The document provides guidance for implantable radiofrequency transponder systems used for patient identification and health information. It outlines risks like adverse tissue reactions, information security issues, device failures, and electromagnetic interference. It recommends measures to address these risks, including biocompatibility testing, information security validation, software validation, performance testing, and electromagnetic compatibility testing. The guidance also covers sterility, MRI compatibility, and labeling. Compliance with the recommendations provides reasonable assurance of safety and effectiveness, allowing exemption from premarket notification requirements.
This document provides coverage guidance for cervical traction devices under Medicare. It specifies:
1. Cervical traction devices are only covered if the beneficiary has a musculoskeletal or neurologic impairment requiring traction and can tolerate the device.
2. Cervical traction devices attached to a headboard or free-standing frame (E0840, E0850) are not reasonable and necessary as over-the-door devices (E0860) have no proven clinical advantage.
3. More specialized cervical traction devices (E0849, E0855) require additional criteria be met related to diagnoses or traction force needs.
Presentation: Patient implant cards and information leaflets – implementationTGA Australia
The document discusses new requirements in Australia and Europe for providing patient implant cards and information leaflets with implantable medical devices. It outlines two models for implant cards - an EU model providing a permanent card at discharge and a US model providing a temporary card at discharge and permanent card from the manufacturer. It also discusses requirements for information to be included on patient information leaflets for implantable devices, such as device identification information, intended purpose, warnings, and adverse event reporting procedures.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
Fda postmarket surveillance-report-september-remediatedgarridosk
This document proposes strengthening the US national system for medical device postmarket surveillance. It outlines 4 key actions: 1) Establish a unique device identification system. 2) Promote national/international device registries. 3) Modernize adverse event reporting and analysis. 4) Develop new methods for evidence generation, synthesis, and appraisal. The goal is a near real-time surveillance system using electronic health data to quickly identify safety issues and characterize device risks and benefits.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
This document summarizes a presentation given by Michael Swit on the FDA's de novo classification process for novel medical devices. It discusses the origins of the de novo pathway, how devices become eligible for de novo review, and the two approaches outlined in a recent draft guidance (pre-de novo submission and traditional petition). It provides details on the format and timing for a pre-de novo submission and de novo petition, as well as how FDA reviews and responds to each. Statistics on de novo petitions approved from 1998-2011 are also presented, broken down by therapeutic area and year. Finally, special controls commonly required as part of the de novo process are summarized.
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
This document provides coverage guidance for cervical traction devices under Medicare. It specifies:
1. Cervical traction devices are only covered if the beneficiary has a musculoskeletal or neurologic impairment requiring traction and can tolerate the device.
2. Cervical traction devices attached to a headboard or free-standing frame (E0840, E0850) are not reasonable and necessary as over-the-door devices (E0860) have no proven clinical advantage.
3. More specialized cervical traction devices (E0849, E0855) require additional criteria be met related to diagnoses or traction force needs.
Presentation: Patient implant cards and information leaflets – implementationTGA Australia
The document discusses new requirements in Australia and Europe for providing patient implant cards and information leaflets with implantable medical devices. It outlines two models for implant cards - an EU model providing a permanent card at discharge and a US model providing a temporary card at discharge and permanent card from the manufacturer. It also discusses requirements for information to be included on patient information leaflets for implantable devices, such as device identification information, intended purpose, warnings, and adverse event reporting procedures.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
Fda postmarket surveillance-report-september-remediatedgarridosk
This document proposes strengthening the US national system for medical device postmarket surveillance. It outlines 4 key actions: 1) Establish a unique device identification system. 2) Promote national/international device registries. 3) Modernize adverse event reporting and analysis. 4) Develop new methods for evidence generation, synthesis, and appraisal. The goal is a near real-time surveillance system using electronic health data to quickly identify safety issues and characterize device risks and benefits.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
This document summarizes a presentation given by Michael Swit on the FDA's de novo classification process for novel medical devices. It discusses the origins of the de novo pathway, how devices become eligible for de novo review, and the two approaches outlined in a recent draft guidance (pre-de novo submission and traditional petition). It provides details on the format and timing for a pre-de novo submission and de novo petition, as well as how FDA reviews and responds to each. Statistics on de novo petitions approved from 1998-2011 are also presented, broken down by therapeutic area and year. Finally, special controls commonly required as part of the de novo process are summarized.
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
FDA Regulation of Mobile Medical ApplicationsMichael Swit
This document provides an overview of the FDA's regulation of mobile medical applications. It summarizes the FDA's 2013 guidance which established three categories for mobile medical apps: 1) those not considered medical devices, 2) those considered medical devices but subject to enforcement discretion due to low risk, and 3) those considered medical devices subject to FDA regulation due to higher risk. It describes the types of apps that fall into each category and provides examples. It also discusses a recent 2014 draft guidance relating to medical device data systems.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
The document outlines the Medical Devices Rules 2015 introduced by the Drug Regulatory Authority of Pakistan. Some key points:
- The rules were introduced to regulate over 1 million medical devices in Pakistan and protect public health by ensuring safety and effectiveness.
- A Medical Devices Board (MDB) is established as the regulatory authority responsible for registration of devices and conformity assessment bodies, issuing licenses, and enforcing implementation of the rules.
- The rules cover various aspects of medical devices including classification, registration, import/export, labeling, usage and advertising. Formats and a fee chart for various regulatory activities are also provided.
The 21st Century Cures Act a focus on Title III Subtitle F – Medical Device I...David Loeser
The 21st Century Cures Act aims to improve and expedite medical device development and regulation. Specifically, Title III Subtitle F focuses on medical device innovations through 10 sections that rewrite rules around devices. This document analyzes 5 key sections: breakthrough devices designation and expedited review (§3051), recognition of standards training for FDA reviewers (§3053), reclassifying some devices (§3054), requiring validated cleaning instructions (§3059), and clarifying software regulation (§3060). The analysis argues these sections will reduce device approval times, improve FDA efficiency, and help safe, effective devices reach patients faster.
2018 Annual Report on China Medical Device RegulationsCIRS China
The annual report summarizes China's medical device regulatory environment and market in 2018. Some key points:
- China approved 206 innovative medical devices in 2018, with 185 produced domestically.
- The NMPA issued numerous regulatory updates, including proposed revisions to the Medical Device Supervision Regulations to reform clinical trials and registration pathways.
- Trends for 2019 include full implementation of the marketing authorization holder system, adjustments to the medical device classification system, and strengthened post-market supervision.
FDA GUIDANCE: Oversight Of Clinical Investigations Risk Based Approach To Mon...crr99999
This draft FDA guidance provides recommendations for using a risk-based approach to monitoring clinical investigations. It encourages sponsors to focus monitoring on critical data and processes, and to use centralized monitoring where appropriate in addition to on-site monitoring. The guidance aims to enhance human subject protection and data quality in clinical trials by making it clear that sponsors have flexibility in designing monitoring strategies.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
General Principals Of Software Validationstaciemarotta
Here are the key definitions and terminology related to software validation:
3.1.1 Requirements and Specifications
Requirements define what the software should do. Specifications define how the software will meet the requirements. Requirements and specifications should be documented, agreed upon, controlled and traceable.
3.1.2 Verification and Validation
Verification ensures the software meets specifications. Validation ensures the software meets the intended use and user needs. Both are required to confirm the software functions as intended and is safe for clinical use.
3.1.3 IQ/OQ/PQ
IQ (Installation Qualification) confirms the software system is installed correctly. OQ (Operational Qualification) confirms the software system operates
The document outlines the Pakistan Medical Devices Rules of 2017. It includes 15 chapters that cover topics such as establishing licenses for medical device manufacturers and importers, classifying and registering medical devices, importing and exporting, labeling, responsibilities of parties, exemptions, usage and maintenance, the Medical Device Board for appeals, the medical device register, fees, and advertising. It also lists the forms associated with the rules.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
The document contains questions and answers about ONC regulations and certification criteria for electronic health records (EHRs). It clarifies that ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) will determine if EHRs meet certification criteria to qualify for certain exceptions and safe harbors. It also addresses questions about certification of specific EHR versions, standards, and whether separate EHR components require their own certification.
This document provides guidance for industry on good abbreviated new drug application (ANDA) submission practices to avoid common deficiencies that can lead to delays in approval. It highlights issues that frequently result in multiple review cycles, including deficiencies related to patents and exclusivity, labeling, product quality, bioequivalence data, and facilities. The guidance aims to help applicants submit more complete applications in order to streamline the ANDA review process.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
Rosemberg Camilo Peñuela was born on February 21, 1994 in Cali, Colombia. The autobiography describes Peñuela's childhood through seven photos with his family in Colombia and Bogota. It shows him growing up with his mother, grandparents, cousin and other loved ones at birthday parties, baptisms, and other celebrations during his early life.
This document discusses themes of love, friendship, and heartbreak through a collection of poems and quotes. It explores the fleeting nature of love compared to the enduring power of true friendship. Friendship is described as delicate yet long-lasting, providing support in difficult times. While love can hurt, real friends accept each other's flaws and are there in times of need.
El documento habla sobre la comunidad de Bolo Madre Vieja, un corregimiento ubicado en el sur de un municipio. La comunidad se caracteriza por ser muy unida y solidaria, donde sus miembros se ayudan mutuamente cuando lo necesitan. El principal entretenimiento son los campeonatos de fútbol que se realizan cada dos meses.
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
FDA Regulation of Mobile Medical ApplicationsMichael Swit
This document provides an overview of the FDA's regulation of mobile medical applications. It summarizes the FDA's 2013 guidance which established three categories for mobile medical apps: 1) those not considered medical devices, 2) those considered medical devices but subject to enforcement discretion due to low risk, and 3) those considered medical devices subject to FDA regulation due to higher risk. It describes the types of apps that fall into each category and provides examples. It also discusses a recent 2014 draft guidance relating to medical device data systems.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
The document outlines the Medical Devices Rules 2015 introduced by the Drug Regulatory Authority of Pakistan. Some key points:
- The rules were introduced to regulate over 1 million medical devices in Pakistan and protect public health by ensuring safety and effectiveness.
- A Medical Devices Board (MDB) is established as the regulatory authority responsible for registration of devices and conformity assessment bodies, issuing licenses, and enforcing implementation of the rules.
- The rules cover various aspects of medical devices including classification, registration, import/export, labeling, usage and advertising. Formats and a fee chart for various regulatory activities are also provided.
The 21st Century Cures Act a focus on Title III Subtitle F – Medical Device I...David Loeser
The 21st Century Cures Act aims to improve and expedite medical device development and regulation. Specifically, Title III Subtitle F focuses on medical device innovations through 10 sections that rewrite rules around devices. This document analyzes 5 key sections: breakthrough devices designation and expedited review (§3051), recognition of standards training for FDA reviewers (§3053), reclassifying some devices (§3054), requiring validated cleaning instructions (§3059), and clarifying software regulation (§3060). The analysis argues these sections will reduce device approval times, improve FDA efficiency, and help safe, effective devices reach patients faster.
2018 Annual Report on China Medical Device RegulationsCIRS China
The annual report summarizes China's medical device regulatory environment and market in 2018. Some key points:
- China approved 206 innovative medical devices in 2018, with 185 produced domestically.
- The NMPA issued numerous regulatory updates, including proposed revisions to the Medical Device Supervision Regulations to reform clinical trials and registration pathways.
- Trends for 2019 include full implementation of the marketing authorization holder system, adjustments to the medical device classification system, and strengthened post-market supervision.
FDA GUIDANCE: Oversight Of Clinical Investigations Risk Based Approach To Mon...crr99999
This draft FDA guidance provides recommendations for using a risk-based approach to monitoring clinical investigations. It encourages sponsors to focus monitoring on critical data and processes, and to use centralized monitoring where appropriate in addition to on-site monitoring. The guidance aims to enhance human subject protection and data quality in clinical trials by making it clear that sponsors have flexibility in designing monitoring strategies.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
General Principals Of Software Validationstaciemarotta
Here are the key definitions and terminology related to software validation:
3.1.1 Requirements and Specifications
Requirements define what the software should do. Specifications define how the software will meet the requirements. Requirements and specifications should be documented, agreed upon, controlled and traceable.
3.1.2 Verification and Validation
Verification ensures the software meets specifications. Validation ensures the software meets the intended use and user needs. Both are required to confirm the software functions as intended and is safe for clinical use.
3.1.3 IQ/OQ/PQ
IQ (Installation Qualification) confirms the software system is installed correctly. OQ (Operational Qualification) confirms the software system operates
The document outlines the Pakistan Medical Devices Rules of 2017. It includes 15 chapters that cover topics such as establishing licenses for medical device manufacturers and importers, classifying and registering medical devices, importing and exporting, labeling, responsibilities of parties, exemptions, usage and maintenance, the Medical Device Board for appeals, the medical device register, fees, and advertising. It also lists the forms associated with the rules.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
The document contains questions and answers about ONC regulations and certification criteria for electronic health records (EHRs). It clarifies that ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) will determine if EHRs meet certification criteria to qualify for certain exceptions and safe harbors. It also addresses questions about certification of specific EHR versions, standards, and whether separate EHR components require their own certification.
This document provides guidance for industry on good abbreviated new drug application (ANDA) submission practices to avoid common deficiencies that can lead to delays in approval. It highlights issues that frequently result in multiple review cycles, including deficiencies related to patents and exclusivity, labeling, product quality, bioequivalence data, and facilities. The guidance aims to help applicants submit more complete applications in order to streamline the ANDA review process.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
Rosemberg Camilo Peñuela was born on February 21, 1994 in Cali, Colombia. The autobiography describes Peñuela's childhood through seven photos with his family in Colombia and Bogota. It shows him growing up with his mother, grandparents, cousin and other loved ones at birthday parties, baptisms, and other celebrations during his early life.
This document discusses themes of love, friendship, and heartbreak through a collection of poems and quotes. It explores the fleeting nature of love compared to the enduring power of true friendship. Friendship is described as delicate yet long-lasting, providing support in difficult times. While love can hurt, real friends accept each other's flaws and are there in times of need.
El documento habla sobre la comunidad de Bolo Madre Vieja, un corregimiento ubicado en el sur de un municipio. La comunidad se caracteriza por ser muy unida y solidaria, donde sus miembros se ayudan mutuamente cuando lo necesitan. El principal entretenimiento son los campeonatos de fútbol que se realizan cada dos meses.
Genghis Khan was born in 1162 in Mongolia and went on to unite the Mongol tribes and create the largest contiguous empire in history. He was raised by his mother after his father died when he was young. In 1206, he united the Mongol tribes under one rule. As leader, called Khan, he expanded the empire through conquest and tolerated other religions. When he died in 1227 at age 65, the Mongol Empire stretched from Eastern Europe to the Sea of Japan. His empire did not last, but he left a lasting legacy for Mongolia.
This document provides instructions for a name pattern project. Students will use colored pencils to write their name in cursive on folded paper, creating a mirrored effect when unfolded. They will then fill in the enclosed spaces with patterns and designs, coloring both sides to create an abstract insect-like figure from their name. The project requires using patterns, coloring all areas, and optionally matching or not matching the patterns on the mirrored sides.
The document provides an overview of Info-Tech Research Group, including:
- They have been serving IT professionals since 1997 and focus on making their work easier and helping them achieve greater success.
- They provide action-oriented advice, practical tools and real solutions to help IT professionals assess trends, make technology decisions, implement new technologies and processes, and manage and improve IT operations.
- Their research includes step-by-step solution sets, access to benchmarking and metrics programs, workshops, and on-demand phone consultations with their research
Angela Mellado Gomez introduces her family which includes her father Fernando, mother Geli, and brother Fernando. She has three pet cats named Cuqui, Lasi, and Tara. Her best friend is Belen and she also has other friends including Tatiana, Paula, Cynthia, Teresa, Celia, Geles, Sonia and Nicole. Her favorite sport is rhythmic gymnastics where her classmates include Sara, Mariam, Arancha, Elena and Julia. Her birthday is October 28th and she is 12 years old. Her favorite hobbies include rhythmic gymnastics, football, basketball, tennis and volleyball.
Anyi Paola Bonilla Henao was born on September 9, 1993 in Chaparral, Tolima, Colombia. She has a sister named Valentina Giraldo Henao and was raised by her parents Elberth Bonilla Garibello and Rubiela Henao Palacio. Some of her earliest memories include her baptism at 3 months old, dressing as Queen of Egypt for Halloween as a child, and celebrating her First Communion in Belalcazar, Caldas at age 10 with her family. Anyi studied at Álvaro Gómez Hurtado School starting at age 11 and hopes to study childhood education at the Technological University of Pereira to help her mother.
The thinkers behind our modern day economieslilyzhang27
The document discusses the economic theories of Karl Marx, Adam Smith, and John Maynard Keynes. It notes that Marx advocated for a command economy where the government controls supply and prices. It describes Smith's support for free market capitalism and an invisible hand regulating supply and demand. The summary describes Keynes' belief that governments should intervene to stabilize prices and interest rates, and that total demand from public and private sectors drives an economy, forming the basis of Keynesian economics.
The German CleanTech Institute (DCTI) is an independent research institute focused on clean and sustainable technologies. It aims to accelerate the promotion and adoption of cleantech through applied research, consulting, information services, and events. DCTI conducts market analyses, feasibility studies, and sustainability assessments to help companies optimize processes and communicate their cleantech commitments. It also publishes reports on various cleantech sectors and hosts a business climate index to monitor industry expectations.
This document provides an overview of customs, cultures and traditions in the Czech Republic presented by a group of students. It discusses the role of family, women, Christmas traditions, etiquette for new acquaintances, and communication patterns. Key points include the importance of family in Czech culture; traditional gender roles with women also working but responsible for home/childcare; Christmas traditions involving St. Nicholas and superstitions; formal greetings and indirect communication style; and maintaining personal space and addressing people formally until the relationship is closer.
The document lists the names of 14 research groups at Info-Tech Research Group in no particular order. Each research group is listed on its own line without any additional details provided about the research areas or members.
Jhenniffer was born in Bogotá in 1995. Her father passed away when she was 4 months old and her mother is Sandra Patricia Gamboa. She started kindergarten at age 5 and elementary school at age 7, after which she moved to Bogotá with her mother and new stepfather Duberney. Jhenniffer is currently living happily with her mother, stepfather, and younger brother Sergio, whom she loves very much.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow, releases endorphins, and promotes changes in the brain which help regulate emotions and stress levels.
Executives and business stakeholders still expect traditional commitments and deadlines, not “sprints” and “velocity.” Find the balance between New School Agility and Old School Command and Control http://bit.ly/1AswlnD
This document is a repetitive list of the phrase "Info-Tech Research Group" appearing on 14 separate lines without any additional context or information provided.
Journal interne de Prêt à Partir Avril 2016. Compensation de nos émissions carbone et développement durable dans l'autocar. Energies renouvelables (photovoltaïque, hydro-électrique, méthanisation). Actions humanitaires au Niger (Niger ma Zaada). Bio-méthane, effet de serre, charte CO2 de l'ADEME, écologie et agences de voyages. François Piot.
This autobiography summarizes key events in the author's life from age 2 to 17. It describes traveling with his mother in a circus at age 2, being born with cousins at age 3, spending time with family at his grandmother's restaurant at age 5, enjoying the garden at age 4, starting school at age 7 where he met lifelong friends, beginning high school at age 11 where he was baptized and made his first communion, and currently studying in 11th grade course 1101 as he prepares to graduate in a few days.
This document provides information about atomic structure and bonding. It discusses:
- The basic components of atoms (protons, neutrons, electrons) and their properties.
- Electron orbitals and energy levels within atoms. Electrons occupy discrete shells and energy levels.
- Covalent bonding between atoms, where valence electrons are shared. This forms crystalline structures.
- Semiconductors like silicon and germanium have incomplete valence shells, so their atoms form covalent bonds to share electrons until each has a full outer shell. This tightly binds electrons.
- Doping semiconductors with impurities introduces extra electrons or holes, increasing conductivity and making the material n-type or p-
This collection of photos documents Jinna Angelica Garcia and her family over several years. The photos show her at age 2 celebrating her brother's birthday with family and beer, age 3 on the beach with her funny father soaking up the sun all day, and age 5 meeting Jesus for the first time, which she remembered as a very special day meeting all her family and people she loved and being very happy.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Watson Megatech, Inc.
% Chad Watson
Dec 1, 2011
President and CEO
5800 Industrial Blvd
Suite 11
Omaha, NE 68135
Re: P091462
BioBanking
Filed: Jan 9, 2010
Amended: August 5, September 8 and 13, 2010; February 22, 2011; September 22, 2011; October 6, 2011 and November 1, 2011.
Procode: RLD
Dear Mr. Watson:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has completed its review of your premarket approval application (PMA) for the BioBanking Device.
BioBanking is intended to be for sub-dermal use as a radio frequency (RF) emitter in the prevention of identity theft and financial fraud. The device will interact with external scanners through radio frequency to identify the individual as well as financial account information. The device will also interact with external encoders for the purposes of addition or removal of financial account information. The device is solar powered and does not need internal batteries that would provide potential medical issues in the PMA review process.
The BioBanking insertion process can be administered by non-medical personnel trained in the implementation of the product. Financial institution personnel responsible for this administration will be trained and certified in application of the BioBanking device.
The sub-dermal BioBanking device is one element of the total transaction system. There is also a reader for the RF signals. Since the reader is a passive device it does not fall under provisions of the CDRH purview.
We are pleased to inform you that the PMA is approved. You may begin commercial distribution
of the device in accordance with the conditions of approval described below. You may continue
commercial distribution of the device upon receipt of this letter.
Page 2 – Mr. Watson
The sale and distribution of this device are governed by The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as: any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,
i. contains or acts as part of an electronic circuit and
ii. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
i. any ionizing or non-ionizing electromagnetic or particulate radiation, or
ii. any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
The device is restricted under section 515(d)(l)(B)(ii) o.
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The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
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The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
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1. Guidance for Industry and FDA Staff
Class II Special Controls Guidance
Document: Implantable
Radiofrequency Transponder
System for Patient Identification
and Health Information
Document issued on: December 10, 2004
For questions regarding the use or interpretation of this guidance contact: Gail Gantt at 240-276-3700
or by email gail.gantt@fda.hhs.gov
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
General Hospital Devices Branch
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
2. Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room
1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted
to http://www.fda.gov/dockets/ecomments. Please identify your comments with the docket
number listed in the notice of availability that publishes in the Federal Register announcing the
availability of this guidance document. Comments may not be acted upon by the Agency until
the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/ode/guidance/1541.pdf, or CDRH Facts-On-Demand. In order to
receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the
second voice prompt, press 1 to order a document. Enter the document number (1541) followed
by the pound sign (#). Follow the remaining voice prompts to complete your request.
3. Table of Contents
1. BACKGROUND..................................................................................................................................................1
2. SCOPE..................................................................................................................................................................2
3. RISKS TO HEALTH ..........................................................................................................................................3
4. RECOMMENDED MITIGATION MEASURES ............................................................................................4
A. BIOCOMPATIBILITY ........................................................................................................................................4
B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)..............................................................4
C. SOFTWARE VALIDATION ................................................................................................................................5
D. MIGRATION TESTING OF IMPLANTED TRANSPONDER .....................................................................................5
E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER ................................................................................5
F. PERFORMANCE TESTING OF INSERTER............................................................................................................5
G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER ...............................................5
H. ELECTROMAGNETIC COMPATIBILITY..............................................................................................................5
I. ELECTRICAL SAFETY PERFORMANCE TESTING ...............................................................................................5
J. STERILITY ......................................................................................................................................................6
K. MAGNETIC RESONANCE IMAGING COMPATIBILITY ........................................................................................6
L. LABELING.......................................................................................................................................................6
5. LIMITATIONS OF EXEMPTION FROM PREMARKET NOTIFICATION ............................................7
4. Contains Nonbinding Recommendations
Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document:
Implantable Radiofrequency Transponder
System for Patient Identification and Health
Information
This guidance represents the Food and Drug Administration's (FDA's) current thinking on
this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed on the title page of this
guidance.
1. Background
This guidance document was developed as a special control guidance to support the
classification of the implantable radiofrequency transponder system for patient identification and
health information into class II (special controls). The device is intended to enable access to
secure patient identification and corresponding health information in humans. This guidance is
issued in conjunction with a Federal Register notice announcing the classification of implantable
radiofrequency transponder system for patient identification and health information.
This guidance document describes a means by which implantable radiofrequency transponder
systems for patient identification and health information may comply with the requirement of
class II special controls. Designation of this guidance document as a special control means that
manufacturers of implantable radiofrequency transponder systems for patient identification and
health information who follow the recommendations listed in this document, before introducing
their device into commercial distribution in the United States, will also be able to market their
device without being subject to the premarket notification requirements of section 510(k) of the
Act.
Section 510(m) of the Act provides that FDA may exempt a class II device from the premarket
notification requirements under section 510(k) of the act if FDA determines that premarket
notification is not necessary to provide reasonable assurance of the safety and effectiveness of
1
5. Contains Nonbinding Recommendations
the device. FDA has determined premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of this generic type of device if the manufacturer
follows the recommendations in this special controls guidance or equivalent measures to address
the risks identified in this guidance. Thus, persons who intend to market a device of this type do
not need to submit a premarket notification to FDA and receive agency clearance prior to
marketing the device, but as a class II device, the device must comply with the other applicable
general and special controls (Section 513(a)(1)(B)).
Following the effective date of a final rule exempting the device, manufacturers of implantable
radiofrequency transponder systems for patient identification and health information will need to
address the issues covered in this special control guidance. However, the manufacturer need
only show that its device meets the recommendations of the guidance or in some other way
provides equivalent assurances of safety and effectiveness.1 If manufacturers cannot comply
with these recommendations or equivalent measures, they will not be exempt from the
requirements of premarket notification and will need to submit a premarket notification and
receive clearance for their device prior to marketing.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
The Least Burdensome Approach
The issues identified in this guidance document represent those that we believe need to be
addressed before your device can be marketed. In developing the guidance, we carefully
considered the relevant statutory criteria for Agency decision-making. We also considered the
burden that may be incurred in your attempt to follow the statutory and regulatory criteria in the
manner suggested by the guidance and in your attempt to address the issues we have identified.
We believe that we have considered the least burdensome approach to resolving the issues
presented in the guidance document. If, however, you believe that there is a less burdensome
way to address the issues, you should follow the procedures outlined in the “A Suggested
Approach to Resolving Least Burdensome Issues” document. It is available on our Center
web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html.
2. Scope
The scope of this document is limited to the following device as described in 21 CFR 880.6300
Implantable Radiofrequency Transponder System for Patient Identification and Health
Information (product code: NRV):
1
We recommend that you document how you have addressed the recommendations in your
design history file. Manufacturers must maintain design controls, including a design history file,
in accordance with 21 CFR 820.30.
2
6. Contains Nonbinding Recommendations
An implantable radiofrequency transponder system for patient identification and health
information is a device intended to enable access to secure patient identification and
corresponding health information. This system may include a passive implanted
transponder, inserter, and scanner. The implanted transponder is used only to store a
unique electronic identification code which is read by the scanner. The identification
code is used to access patient identity and corresponding health information stored in a
database.
3. Risks to Health
In the table below, FDA has identified the risks to health generally associated with the use of the
Implantable Radiofrequency Transponder System for Patient Identification and Health
Information addressed in this document. FDA recommends the following measures to mitigate
the identified risks in this guidance, as shown in the table below.
Recommended mitigation measures
Identified risk
(See the corresponding subheading in section 4)
A. Biocompatibility
Adverse Tissue Reaction J. Sterility
L. Labeling
Migration of implanted transponder D. Migration Testing of Implanted Transponder
B. Information Security Procedures (Design and
Compromised Information Security
Validation)
E. Performance Testing of Implanted Transponder
Failure of implanted transponder
L. Labeling
Failure of Inserter F. Performance Testing of Inserter
G. Performance Testing and Hazard Analysis of
Failure of electronic scanner Electronic Scanner
C. Software Validation
L. Labeling
H. Electromagnetic compatibility
Electromagnetic Interference
L. Labeling
I. Electrical Safety performance testing
Electrical Hazards
L. Labeling
Magnetic Resonance Imaging K. Magnetic Resonance Imaging Compatibility
Incompatibility L. Labeling
Needle stick L. Labeling
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7. Contains Nonbinding Recommendations
4. Recommended Mitigation Measures
FDA believes that conformance with this guidance document, when combined with the general
controls of the Act, will provided reasonable assurance of the safety and effectiveness of the
implantable radiofrequency transponder system for patient identification and health information.
We recommend that you (the manufacturer) evaluate your device as described below and, where
appropriate, document the results in your design history file as a part of the Quality Systems
Requirements (21 CFR 820.30).
A. Biocompatibility
We recommend that you ensure the biocompatibility of the patient-contacting parts of your
device by following the tests in the:
• International Standard Organization (ISO) standard ISO-10993, Biological
Evaluation of Medical Devices Part 1: Evaluation and Testing.
B. Information Security Procedures (Design and Validation)
When discussing the issue of medical devices that store, access, and/or transfer information
externally, you should address the concept of information security. Information security is
the process of preventing the modification, misuse or denial of use, or the unauthorized use
of that information. We recommend that your specifications for a compatible database
address the following four components of information security: Confidentiality, Integrity,
Availability, and Accountability (CIAA).
• Confidentiality means the characteristic of data and information being
disclosed only to authorized persons, entities and processes at authorized
times and in the authorized manner. (The assurance that no unauthorized
users have access to the information.)
• Integrity means the characteristic of data and information being accurate and
complete and the preservation of accuracy and completeness. (The
assurance that the information is correct (accurate and complete) - that is, it
has not been improperly modified.)
• Availability means the characteristic of data, information and information
systems being accessible and usable on a timely basis in the required manner.
(The assurance that the information will be available when needed.)
• Accountability is the application of identification and authentication to assure
that the prescribed access process is being done by an authorized user.
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8. Contains Nonbinding Recommendations
C. Software Validation
We recommend that you validate the software in your device by referring to the following
guidance:
• Guidance for FDA Reviewers and Industry Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices
http://www.fda.gov/cdrh/ode/57.html
• General Principles of Software Validation; Final Guidance for Industry and
FDA Staff
http://www.fda.gov/cdrh/comp/guidance/938.html
D. Migration Testing of Implanted Transponder
We recommend that you conduct testing of the implanted transponder to demonstrate that the
transponder will not migrate after implantation.
E. Performance Testing of Implanted Transponder
We recommend that you conduct testing of the transponder that will demonstrate that under
conditions of use the transponder sends an identification (ID) code and that the ID code is
correct. The testing should address loss or corruption of the data, latency and through-put,
and be coordinated with the electromagnetic compatibility (EMC) performance of the
implant, scanner and wireless data link.
F. Performance Testing of Inserter
We recommend that you demonstrate the functionality of the insertion device by conducting
testing that demonstrates that inserter can properly implant the transponder.
G. Performance Testing and Hazard Analysis of Electronic Scanner
We recommend that you address the functionality of the electronic scanner by conducting
performance testing and hazard analysis that demonstrate the scanner utility in reading the
transponder identification code.
H. Electromagnetic Compatibility
We recommend that you demonstrate the basic EMC of the device (i.e., transponder and
scanner together) by performing EMC testing in accordance with the following FDA-
recognized standard:
• IEC 60601-1-2 (Second Edition, 2001) Medical electrical equipment - Part1:
General requirements for safety; Electromagnetic compatibility -
Requirements and Tests, or its equivalent.
I. Electrical Safety Performance Testing
We recommend that you demonstrate the electrical safety of your device by following the
testing in:
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9. Contains Nonbinding Recommendations
• IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements
for Safety
J. Sterility
We recommend that the transponder and inserter be sterile with a sterility assurance level of
10-6. We also recommend that you address the sterility of your device by reviewing the
following:
• Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for
Industry and FDA. http://www.fda.gov/cdrh/ode/guidance/361.html.
K. Magnetic Resonance Imaging Compatibility
We recommend that you demonstrate the magnetic resonance imaging compatibility of your
device by following:
• ASTM F2052-02 Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the Magnetic Resonance
Environment
• ASTM F2182-02a Standard Test Method for Measurement of Radio
Frequency Induced Heating Near Passive Implants During Magnetic
Resonance Imaging
• ASTM F2213-04 Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119-01 Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants.
In addition, you should also address the EMC concerns for implant exposure to the
significant magnetic and radiofrequency emissions from MRI, including concerns for
implant malfunction or damage from MRI exposure and the use of the scanner during MRI
procedures.
L. Labeling
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate
directions for lay use.2
2
Final labeling must comply with the requirements of 21 CFR 801 before a medical device is
introduced into interstate commerce.
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10. Contains Nonbinding Recommendations
We recommend that instructions delineate the technological features of the specific device
and how the device is to be used on patients. We recommend that the instructions encourage
local/institutional training programs designed to familiarize users with the features of the
device and how to use it in a safe and effective manner. If there are any precautions or
warnings, which relate to packaging or sterility, these should be repeated on the package
labels.
We also recommend that you provide after surgery care instructions to the patient. See also
Guidance on Medical Device Patient Labeling,
http://www.fda.gov/cdrh/ohip/guidance/1128.html.
5. Limitations of Exemption from Premarket Notification
FDA's decision to exempt a Class II device from the requirement of premarket notification is
based on the existing and reasonably foreseeable characteristics of devices within that generic
type that currently are, or have been, in commercial distribution. Section 21 CFR 880.9 specifies
the limitations to exemption. If any of these limitations apply, your device is not exempt and
you must submit a premarket notification.
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