The document summarizes the Code of Federal Regulations Title 21 Part 822, which provides procedures and requirements for post-market surveillance of medical devices. It outlines the subparts which address general provisions, notification, post-market surveillance plans, FDA review and action, responsibilities of manufacturers, waivers and exemptions, and records and reports. The purpose is to implement post-market surveillance authority to maximize collection of useful safety data on medical devices after market release. Manufacturers must submit surveillance plans for FDA approval and are responsible for conducting approved plans to monitor devices and report data and issues.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Documentation in Pharmaceutical Industry.pptxAartiVats5
This document discusses various types of documentation required in the pharmaceutical industry, including exploratory product development briefs (EPDBs), product development plans (PDPs), and product development reports (PDRs). It also discusses drug master files (DMFs). The EPDB describes the drug substance and product. The PDP provides guidance for product development stages. The PDR provides a comprehensive understanding of the product and manufacturing process. Finally, the DMF contains confidential information used to support regulatory requirements for quality, safety and efficacy.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Documentation in Pharmaceutical Industry.pptxAartiVats5
This document discusses various types of documentation required in the pharmaceutical industry, including exploratory product development briefs (EPDBs), product development plans (PDPs), and product development reports (PDRs). It also discusses drug master files (DMFs). The EPDB describes the drug substance and product. The PDP provides guidance for product development stages. The PDR provides a comprehensive understanding of the product and manufacturing process. Finally, the DMF contains confidential information used to support regulatory requirements for quality, safety and efficacy.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
International Medical Device Regulators ForumSanthiNori1
The document summarizes the International Medical Device Regulators Forum (IMDRF), which was established in 2011 to accelerate international harmonization of medical device regulations. It provides background on IMDRF's establishment and membership, which includes regulators from 11 countries and regions. The document also discusses IMDRF's relationship to the prior Global Harmonization Task Force (GHTF) and describes IMDRF's management structure, meetings, and current working groups on issues like adverse event terminology and medical device cybersecurity.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
This document provides a checklist of documents required for obtaining market authorization in various BRICS countries. It introduces BRICS as an emerging market comprising Brazil, Russia, India, China and South Africa. Reasons for the emergence of BRICS markets include declining growth in developed markets and availability of patient populations in emerging markets. The checklist then outlines the documents required for market authorization from the regulatory authorities in India, China, South Africa and other BRICS countries. These include application forms, composition details, clinical trial reports, GMP certificates, and other product-specific documents.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
The STED (Summary of Technical Documentation) is a document that manufacturers of IVD medical devices must compile to demonstrate conformity with regulations. It provides:
1) A detailed description of the device's intended purpose and performance.
2) Information on design, manufacturing, safety and performance testing to show compliance with standards.
3) A checklist mapping requirements to how the device meets each essential principle.
The STED is required for premarket review of Class C and D devices and may be requested post-market. It provides regulators a summary of a device's technical file for audit purposes. Higher risk devices require more detailed information in the STED. The level of information helps determine conformity.
This document discusses Good Automated Laboratory Practices (GALP) which provide guidance for managing automated regulated laboratories. It outlines the importance of standard operating procedures, documentation, logs, training, and concludes that GALP helps streamline laboratory processes and ensures work can be done efficiently within shorter timeframes. Key aspects of GALP covered include security, data management, error handling, change control, archiving, backup and recovery, and hardware maintenance.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Clinical investigation and evaluation of medical devices and ivd.pptxreechashah2
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
21 CFR Part 822 Post Marketing Surveillance.pptxMayur Patil
This document summarizes the key points from a seminar presentation on 21 CFR Part 822 Post Marketing Surveillance. It discusses how post-marketing surveillance helps monitor medical devices for side effects after market launch. It outlines the subparts that describe general provisions, notification requirements, post-market surveillance plan submission, FDA review process, manufacturer responsibilities, waivers and exemptions, record keeping and reporting. The presentation provides an overview of the regulatory requirements for conducting post-market surveillance of medical devices to identify unforeseen adverse events.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
International Medical Device Regulators ForumSanthiNori1
The document summarizes the International Medical Device Regulators Forum (IMDRF), which was established in 2011 to accelerate international harmonization of medical device regulations. It provides background on IMDRF's establishment and membership, which includes regulators from 11 countries and regions. The document also discusses IMDRF's relationship to the prior Global Harmonization Task Force (GHTF) and describes IMDRF's management structure, meetings, and current working groups on issues like adverse event terminology and medical device cybersecurity.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
This document provides a checklist of documents required for obtaining market authorization in various BRICS countries. It introduces BRICS as an emerging market comprising Brazil, Russia, India, China and South Africa. Reasons for the emergence of BRICS markets include declining growth in developed markets and availability of patient populations in emerging markets. The checklist then outlines the documents required for market authorization from the regulatory authorities in India, China, South Africa and other BRICS countries. These include application forms, composition details, clinical trial reports, GMP certificates, and other product-specific documents.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
The STED (Summary of Technical Documentation) is a document that manufacturers of IVD medical devices must compile to demonstrate conformity with regulations. It provides:
1) A detailed description of the device's intended purpose and performance.
2) Information on design, manufacturing, safety and performance testing to show compliance with standards.
3) A checklist mapping requirements to how the device meets each essential principle.
The STED is required for premarket review of Class C and D devices and may be requested post-market. It provides regulators a summary of a device's technical file for audit purposes. Higher risk devices require more detailed information in the STED. The level of information helps determine conformity.
This document discusses Good Automated Laboratory Practices (GALP) which provide guidance for managing automated regulated laboratories. It outlines the importance of standard operating procedures, documentation, logs, training, and concludes that GALP helps streamline laboratory processes and ensures work can be done efficiently within shorter timeframes. Key aspects of GALP covered include security, data management, error handling, change control, archiving, backup and recovery, and hardware maintenance.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Clinical investigation and evaluation of medical devices and ivd.pptxreechashah2
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
21 CFR Part 822 Post Marketing Surveillance.pptxMayur Patil
This document summarizes the key points from a seminar presentation on 21 CFR Part 822 Post Marketing Surveillance. It discusses how post-marketing surveillance helps monitor medical devices for side effects after market launch. It outlines the subparts that describe general provisions, notification requirements, post-market surveillance plan submission, FDA review process, manufacturer responsibilities, waivers and exemptions, record keeping and reporting. The presentation provides an overview of the regulatory requirements for conducting post-market surveillance of medical devices to identify unforeseen adverse events.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
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.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Su...Jon Lendrum
The document provides an overview of a workshop on assembling 510(k) submissions for the FDA. It discusses selecting a predicate device, organizing data, and preparing the actual 510(k) submission. Key points include understanding FDA Form 3654 (Standards Data Report), tips and best practices for 510(k) submissions, potential pitfalls, and common mistakes. The workshop objectives are to help attendees understand how to select a predicate device, collect and organize required data, and understand the overall 510(k) process.
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
Medical Device Post-Market Surveillance RequirementsEMMAIntl
Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented so that manufacturers understood that their device is still their responsibility even after it has left their manufacturing site and entered the market. PMS is intended to be a reporting system that manufacturers can utilize to continuously monitor device performance and learn from any mistakes such as adverse events...
Premarket Notification 510(k) for Biologics [Autosaved].pptxSusmithaTella2
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...CitiusTech
CitiusTech delivered a poster presentation on the FDA compliance landscape (PMA, De Novo, 510k and Pre Cert) and its implication on AI in Healthcare, at the Mayo Clinic AI Symposium earlier this year.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
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.
This proposal outlines the commercialization pathway for an investigational in vitro diagnostic (IVD) device for nonalcoholic fatty liver disease (NAFLD). They were unable to identify a substantially equivalent predicate device, so they plan to submit a formal pre-submission to the FDA to obtain guidance on the appropriate regulatory pathway. The proposed studies funded by this proposal would support information needed for the pre-submission, including analytical validation and performance characteristics of the test. Depending on FDA feedback, the pathway may involve de novo classification, reclassification, or premarket approval.
Medical device approval chart for Mexico - Emergo EMERGO
In Mexico, medical devices and in-vitro diagnostic devices are regulated by COFEPRIS, a division of the Mexican Ministry of Health. The regulatory process involves classifying the device, appointing a Mexico Registration Holder representative, preparing a registration dossier in Spanish including documentation of quality management and technical specifications, and submitting the application to COFEPRIS for review. Approval time ranges from 1-10 months depending on the device class and review process. Registrations are valid for 5 years and must be renewed in advance of the expiration date.
China medical device approval chart - EMERGOEMERGO
1. The document outlines the regulatory process for medical devices in China, including classification of devices and the approval process for Class I, II, and III devices.
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3. The approval process can take 12-22 months for Class II and III devices and involves appointing a Chinese agent, submitting documentation and application materials in Chinese, testing, and a review by the China Food and Drug Administration before a registration certificate is issued.
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Similar to Cfr code of federal regulations-1 (1) (20)
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Cfr code of federal regulations-1 (1)
1. CFR- CODE OF FEDERAL REGULATIONS
TITLE 21--FOOD AND DRUGS
PART 822
POSTMARKET SURVEILLANCE
By:
N. Sai sree
I/II M PHARMACY
(Regulatory affairs)
CHALAPATHI INSTITUTE OF PHARMACEUTICAL
SCIENCES
2. What is CFR??
• The CFR is the codification of the general and permanent rules and
regulations published in the Federal Register by the executive departments
and agencies of the federal government of the United States. The CFR is
divided into 50 titles that represent broad areas subject to federal regulation.
Post marketing surveillance is the practice of
monitoring the safety of a pharmaceutical drug or
medical device after it has been released on
the market and is an important part of the science
of pharmacovigilance
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
3. SUB PARTS:
Sub part A - General provisions
Sub part B - Notification
Sub part C - Post market surveillance plan
Sub part D - FDA Reviews and action
Sub part E - Responsibilities of manufacturer’s
Sub part F - Waivers and Exemptions
Sub part G - Records and reports
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
4. SUBPART A--GENERAL PROVISIONS (822.1-822.4)
• This part implements section 522 of
the Federal Food, Drug, and Cosmetic
Act (the act) by providing procedures
and requirements for post market
surveillance.
Sec. 822.1 What
does this part
cover?
• The purpose of this part is to
implement our post market
surveillance authority to maximize the
likelihood that PMS plans will result in
the collection of useful data.
Sec. 822.2 What is
the purpose of this
part?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
5. • Some of the terms we use in this
part are specific to post market
surveillance and reflect the
language used in the statute
(law).
Sec. 822.3 How do
you define the terms
used in this part?
• If we have ordered you to
conduct post market surveillance
of a medical device under
section 522 of the act, this part
applies to you.
Sec. 822.4 Does
this part apply to
me?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
6. SUB PART B- NOTIFICATION(822.5-822.7)
Sec. 822.5 How will I
know if I must conduct post
market surveillance?
We will send you a letter
notifying you of the
requirement to conduct
post market surveillance.
Sec. 822.6 When will you
notify me that I am
required to conduct post
market surveillance?
They will notify during
the review of a marketing
application for your
device, as your device
goes to market, or after
your device has been
marketed for a period of
time.
Sec. 822.7 What should I
do if I do not agree that
post market surveillance is
appropriate?
If you do not agree you
may request review of our
decision by requesting a
meeting with the Director
Office of Surveillance
and Biometrics, who
generally issues the order
for post market
surveillance.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
7. SUBPART C-POST MARKET SURVEILLANCE PLAN (822.8 822.15)
Sec. 822.8 When I submit my post market surveillance
plan?
• You must submit your plan within 30 days of the date you
receive the post market surveillance order.
Sec. 822.9 What must I include in my submission?
• Your submission must include the following:
• Organizational/administrative information.
• Post market surveillance plan.
• Designated person information.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
8. Sec. 822.10 What must I
include in my surveillance
plan?
• It includes:
• The investigator agreement, if
applicable;
• Sources of data, e.g., hospital
records;
• The data collection plan and
forms;
• Sample size and units of
observation.
Sec. 822.11 What should I
consider when designing
my plan to conduct post
market surveillance?
• If any, patient protection
measures should be
incorporated into your plan.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
9. Sec. 822.12 Do you have any information that will help me prepare my submission or
design my post market surveillance plan?
Guidance documents that discuss our current thinking on preparing a post market
surveillance submission and designing a post market surveillance plan are available.
Sec. 822.13 [Reserved].
Sec. 822.14 May I reference information previously submitted instead of submitting it
again?
Yes, you may reference information that you have submitted in premarket submissions
as well as other post market surveillance submissions.
Sec. 822.15 How long must I conduct post market surveillance of my device?
The length of post market surveillance will depend on the post market surveillance
question identified in our order. We may order prospective surveillance for a period up to 36
months, longer periods require your agreement.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
10. SUBPART D- FDA REVIEW AND ACTION(822.16 -822.23)
• First, we will determine that the submission is
administratively complete. Then, in
accordance with the law whether the
designated person has appropriate
qualifications and experience
Sec. 822.16 What will you
consider in the review of
my submission?
• We will review your submission within 60 days
of receipt
Sec. 822.17 How long will
your review of my
submission take?
• We will send you a letter notifying you of our
decision and identifying any action you must
take.
Sec. 822.18 How will I be
notified of your decision?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
11. Sec. 822.19 What kinds of decisions may you make?
If your plan: Then we will send you: And you must:
Should result in the
collection of useful data
that will address the post
market surveillance
question
An approval order,
identifying any specific
requirements related to
your post market
surveillance
Conduct post market
surveillance of your
device in accordance
with the approved plan
Is not likely to result in
the collection of useful
data that will address the
post market surveillance
question
A letter disapproving
your plan and
identifying the reasons
for disapproval
Revise your post market
surveillance submission
and submit it to us
within the specified
timeframe. We will
determine the timeframe
case-by-case, based on
the types of revisions or
information that you
must submit
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
12. If fail to
submit plan then
failure to comply
with section 522 of
the act. Your
failure would be a
prohibited act
under section
301(q)(1)(C) of the
act, and your
device would be
misbranded under
section 502(t)(3)
of the act.
Sec. 822.20
What are the
consequences if I
fail to submit a
post market
surveillance
plan?
You must
submit three
copies of the
request to make
the proposed
change and revised
post market
surveillance plan
to the applicable
address with
making changes in
your plan that will
not affect the
nature or validity
of the data.
Sec. 822.21 What
must I do if I
want to make
changes to my
post market
surveillance plan
after you have
approved ?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
13. CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
Sec. 822.22
What recourse
do I have if I
do not agree
with your
decision?
Same as that of 822.7
Sec. 822.23 Is
the information
in my
submission
considered
confidential?
We consider the content of your
submission confidential until we
have approved your post market
surveillance plan.
14. SUBPART E--RESPONSIBILITIES OF MANUFACTURERS
(822.4 – 822.8)
Sec. 822.24 What are my
responsibilities once I am
notified that I am required
to conduct post market
surveillance?
• You must submit your
plan to conduct post
market surveillance to us
within 30 days from
receipt of the order
(letter) notifying you that
you are required to
conduct post market
surveillance of a device.
Sec. 822.25 What are my
responsibilities after my
post market surveillance
plan has been approved?
• After we have approved
your plan, you must
conduct the post market
surveillance of your
device in accordance with
your approved plan.
Sec. 822.26 If my company
changes ownership, what
must I do?
• You must notify us within
30 days of any change in
ownership of your
company.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
15. • You must notify us within 30 days of
the date of your decision to close your
business. You should provide the
expected date of closure and discuss
your plans to complete or terminate
post market surveillance of your
device.
Sec. 822.27 If I go
out of business,
what must I do?
• You may request that we allow you to
terminate post market surveillance or
modify your post market surveillance
because you no longer market the
device.
Sec. 822.28 If I
stop marketing the
device subject to
post market
surveillance, what
must I do?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
16. SUBPART F--WAIVERS AND EXEMPTIONS (822.29 – 822.30)
• You may request that we waive any
specific requirement of this part. You may
submit your request, with supporting
documentation, separately or as a part of
your post market surveillance submission
to the address.
Sec. 822.29 May I request
a waiver of a specific
requirement of this part?
• You may request exemption from the
requirement to conduct post market
surveillance for your device or any specific
model of that device at any time.
Sec. 822.30 May I request
exemption from the
requirement to conduct
post market surveillance?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
17. SUBPART G-RECORDS AND REPORTS (822.31 – 822.38)
Sec. 822.31 What records am I required to keep?
You must keep copies of:
All correspondence with your investigators or FDA, including required reports;
Your approved post market surveillance plan, with documentation of the date and
reason for any deviation from the plan;
All data collected and analyses conducted in support of your post market surveillance
plan.
Sec. 822.32 What records are the investigators in my surveillance plan required to
keep?
Your investigator must keep copies of:
All correspondence between investigators, FDA, the manufacturer, and the designated
person, including required reports.
The approved post market surveillance plan, with documentation of the date and reason
for any deviation from the plan.
All data collected and analyses conducted at that site for post market surveillance.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
18. • You, the designated person, and your
investigators must keep all records for a
period of 2 years after we have accepted
your final report.
Sec. 822.33 How long
must we keep the records?
• you must ensure that all records related to
the post market surveillance have been
transferred to the new sponsor or
investigator and notify us within 10
working days of the effective date of the
change.
Sec. 822.34 What must I
do with the records if the
sponsor of the plan or an
investigator in the plan
changes?
• We can review your post market
surveillance programs during regularly
scheduled inspections initiated to
investigate recalls or other similar actions,
and inspections initiated specifically to
review your post market surveillance plan.
Sec. 822.35 Can you
inspect my manufacturing
site or other sites involved
in my post market
surveillance plan?
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES
19. Sec. 822.36 Can you
inspect and copy the
records related to my
post market
surveillance plan?
• We may, at a
reasonable time
and in a reasonable
manner, inspect
and copy any
records pertaining
to the conduct of
post market
surveillance that
are required to be
kept by this
regulation.
Sec. 822.37 Under
what circumstances
would you inspect
records identifying
subjects?
• We are likely to be
interested in such
records if we have
reason to believe
that required
reports have not
been submitted, or
are incomplete,
inaccurate, false, or
misleading.
Sec. 822.38 What
reports must I submit
to you?
• You must submit
interim and final
reports as specified
in your approved
post market
surveillance plan.
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES