The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
This document discusses regulatory approval requirements for medical devices. It notes that medical devices must be approved by regulators in over 80 countries worldwide. Key requirements include defining the device and intended use, ensuring safety and effectiveness, and that benefits outweigh risks. Regulatory controls include audits, quality management systems, premarket reviews, postmarket surveillance, and assigning devices to one of four risk classes. The document outlines Cochlear's regulatory approval process, including developing a regulatory strategy and plan, clinical evidence, and generating a Summary Technical Documentation for submission to regulators. It emphasizes that high quality documentation is essential for regulatory approval.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
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.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
This document discusses regulatory approval requirements for medical devices. It notes that medical devices must be approved by regulators in over 80 countries worldwide. Key requirements include defining the device and intended use, ensuring safety and effectiveness, and that benefits outweigh risks. Regulatory controls include audits, quality management systems, premarket reviews, postmarket surveillance, and assigning devices to one of four risk classes. The document outlines Cochlear's regulatory approval process, including developing a regulatory strategy and plan, clinical evidence, and generating a Summary Technical Documentation for submission to regulators. It emphasizes that high quality documentation is essential for regulatory approval.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
Regulatory approval process for invitro diagnostics in usVinod Raj
This document summarizes the regulatory approval process for in vitro diagnostics (IVDs) in the United States. IVDs are classified into Class I, II, or III based on risk, with Class III devices requiring premarket approval. The main regulatory pathways for approval are 510(k) premarket notification for demonstrating substantial equivalence to a predicate device or the premarket approval (PMA) process for novel high-risk devices. Clinical Laboratory Improvement Amendments also provide quality standards for lab testing. The document reviews the classification system and options for 510(k), PMA, de novo, and lab developed tests.
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.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
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.
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.
This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisationpi
Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.
One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This presentation zooms in on the definition and categorisation, as used by the International Medical Device Regulators Forum.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
This document discusses investigational device exemption (IDE) and post marketing surveillance. IDE allows investigational devices to be used in clinical studies to collect safety and effectiveness data, requiring approval by an institutional review board and FDA for significant risk devices. Post marketing surveillance monitors the safety of medical devices after market release using approaches like spontaneous reporting databases and patient registries to identify potential safety issues and provide long-term monitoring of effects. Both are important parts of ensuring device safety during development and after approval.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
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.
The document discusses the product lifecycle of medical devices. It begins with an introduction that defines the basic phases of a product lifecycle as research, development, production, and end of life. It then outlines 6 key phases in the medical device product lifecycle: 1) Concept, 2) Planning, 3) Design, 4) Validation, 5) Launch, and 6) Post-market. Each phase is described in 1-2 sentences. For example, the Concept phase involves initially defining the product and exploring funding/routes to market, while the Post-market phase includes ongoing surveillance and reporting to continuously evaluate safety.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
This standard provides requirements for testing dietary supplements to ensure ingredients are accurately identified and labeled. It requires supplements to be tested to confirm identity, quantity, and limits on contaminants like metals, pesticides, and microbes. The standard also provides criteria for good manufacturing practices. It applies to supplements containing vitamins, minerals, herbs, amino acids, or other botanical ingredients but excludes conventional foods.
The document provides an overview of the FDA's regulation of medical devices. It explains that the FDA evaluates the safety and effectiveness of devices before and after they reach the market. The FDA classifies devices into three classes based on risk, with class III devices having the strictest controls. There are several types of premarket submissions required by the FDA to get a new device to market, including 510(k) notifications, PMA applications, and IDEs for investigational devices. The document outlines the basic steps and recommends users understand their regulatory responsibilities, stay informed, and utilize FDA resources.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
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.
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.
This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisationpi
Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.
One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This presentation zooms in on the definition and categorisation, as used by the International Medical Device Regulators Forum.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
This document discusses investigational device exemption (IDE) and post marketing surveillance. IDE allows investigational devices to be used in clinical studies to collect safety and effectiveness data, requiring approval by an institutional review board and FDA for significant risk devices. Post marketing surveillance monitors the safety of medical devices after market release using approaches like spontaneous reporting databases and patient registries to identify potential safety issues and provide long-term monitoring of effects. Both are important parts of ensuring device safety during development and after approval.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
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.
The document discusses the product lifecycle of medical devices. It begins with an introduction that defines the basic phases of a product lifecycle as research, development, production, and end of life. It then outlines 6 key phases in the medical device product lifecycle: 1) Concept, 2) Planning, 3) Design, 4) Validation, 5) Launch, and 6) Post-market. Each phase is described in 1-2 sentences. For example, the Concept phase involves initially defining the product and exploring funding/routes to market, while the Post-market phase includes ongoing surveillance and reporting to continuously evaluate safety.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
This standard provides requirements for testing dietary supplements to ensure ingredients are accurately identified and labeled. It requires supplements to be tested to confirm identity, quantity, and limits on contaminants like metals, pesticides, and microbes. The standard also provides criteria for good manufacturing practices. It applies to supplements containing vitamins, minerals, herbs, amino acids, or other botanical ingredients but excludes conventional foods.
The document provides an overview of the FDA's regulation of medical devices. It explains that the FDA evaluates the safety and effectiveness of devices before and after they reach the market. The FDA classifies devices into three classes based on risk, with class III devices having the strictest controls. There are several types of premarket submissions required by the FDA to get a new device to market, including 510(k) notifications, PMA applications, and IDEs for investigational devices. The document outlines the basic steps and recommends users understand their regulatory responsibilities, stay informed, and utilize FDA resources.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
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.
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.
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.
This document outlines the agenda for a conference on obtaining FDA approval for AI-based medical devices. The agenda includes presentations on paving the path for FDA approval of AI devices, an open Q&A session with the FDA's Digital Health Center of Excellence, how to align product development with FDA regulations for AI, best pre-submission practices, and an update on the 510(k) program. There will also be breaks and a summary session. The presentations will provide guidance on navigating the FDA approval process for AI medical devices and obtaining feedback prior to formal submissions.
Using Clinical Studies to Support Claims for 510(k) Devices. Michael Swit
The document summarizes Michael Swit's presentation on using clinical studies to support claims for 510(k) medical devices. It discusses the FDA's views on using clinical literature to support labeling and advertising claims. It notes that clinical investigations can be used to support claims if they are for the device's intended use. The presentation also examines case studies where companies improperly used clinical literature or studies to promote off-label uses. It emphasizes that the goal for 510(k) devices is to demonstrate substantial equivalence, not superiority claims.
Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices.
They may be simple tools used during medical examinations,
such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents.
The federal agency responsible for regulating medical devices is the Food and Drug
Administration (FDA)—an agency within the Department of Health and Human Services (HHS).
A manufacturer must obtain FDA’s prior approval or clearance before marketing many medical
devices in the United States.
FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review.
Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.
Under the terms of the Medical Device Amendments of 1976
FDA classified all medical devices that were on the market at the time of enactment— the Pre amendment devices—into one of three classes.
Congress provided definitions for the three
classes—Class I, Class II, and Class III—based on the risk (low-, moderate-, and high-risk
respectively) to patients posed by the devices.
A PMA is “the most stringent type of device marketing application required by FDA” for new and/or high-risk devices.
PMA approval is based on the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s)
PMAs generally require some clinical data prior to FDA making an approval decision.
All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated.
An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical study to collect the data required to support a PMA submission.
The IDE permits a device to be shipped lawfully for investigation of the device without requiring that the manufacturer comply with other requirements of the FFDCA, such as registration and listing.
A PMA must contain (among other things) the following information:
summaries of nonclinical and clinical data supporting the application and conclusions drawn from the studies;
a device description including significant physical and performance characteristics;
indications for use, description of the patient population and disease or condition that the device will diagnose, treat, prevent, cure, or mitigate;
a description of the foreign and U.S. marketing history, including if the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device;
proposed labeling; and
a description of the manufacturing process.
If a manufacturer wants to make a change to an approved PMA device.
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.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
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.
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
An Overview of The “De Novo” Process – Reclassifying Devices Automatically Pl...Michael Swit
Presentation to the Drug Information Association (DIA) Annual Meeting, June 26, 2013, focusing on:
* Development of de novo concept
* FDAMA changes
* FDA guidances
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
This document discusses regulations for medical devices in various countries and regions. It provides an overview of the regulatory bodies that oversee medical devices in Australia, Europe, the US, Canada, China, Japan, Brazil, and India. For the US, it describes the Food and Drug Administration's role and classifications of medical devices. It also summarizes key concepts around establishing registration and listing of devices, premarket notification (510(k)), de novo classification, premarket approval, and quality system regulations.
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.
Similar to Overview of FDA Regulation of Devices & Diagnostics (20)
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
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FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
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Overview of FDA Regulation of Devices & Diagnostics
1. Overview of FDA Regulation
of Devices & Diagnostics
Michael A. Swit, Esq.
Vice President
LARTA
NIH-CAP Program
Webinar
February 2008
2. 2
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
may not be relied upon solely on its own to
reach any conclusion of law or fact.
3. 3
Regulatory Overview
• Food and Drug Administration is the sole
federal agency regulating safety and effectiveness
for medical devices
• Medical devices first regulated by FDA in 1938
• 1976 -- Major reform of regulations occurred in
Device Amendments
4. 4
Statutory Overview
• Safe Medical Devices Act of 1990 (SMDA)
– Problems with the “76” amendments; left a lot of
leeway for industry to work around the more
stringent requirements of the amendments
– SMDA initiated more market entry “Gatekeeper”
functions, enforcement and compliance, safety and
post-marketing surveillance
– Resulted in Quality System Regulation (QSR)
5. 5
Statutory Overview
• Medical Device Amendment of 1992 --
“tweaking of the law”
• FDAMA -- Food and Drug Modernization Act
of 1997 -- key theme -- FDA’s mission includes
timely review and approval of beneficial new
products
• MDUFMA – 2002 -- User Fees and additional
tweaks (e.g., combination products)
6. 6
What is a Medical Device?
• Section 201(h) of the FDCA defines a device as:
… an instrument, apparatus implement, contrivance, implant, in vitro reagent,
or other similar or related article, including components, parts or accessories
which are;
(1) Recognized in the National Formulary, or US Pharmacopeia
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease
(3) intended to affect the structure or any function of the body and which
does not achieve its primary intended purposes through chemical
action within or on the body and which is not dependent upon being
metabolized for the achievement of its primary intended purposes
7. 7
Device Classification
• Risk based
– Class I -- includes devices with the lowest risk,
subject to general controls – e.g., labeling, listing,
QSRs, etc.
– Class II -- includes devices for which general
controls are insufficient to assure safety and
effectiveness -- mandatory performance standards
8. 8
Device Classification …
• Class III -- devices with the greatest risk and
insufficient information exists to assure safety
and efficacy
– generally require a PMA submission
– “Post amendment” Class III devices considered
substantially equivalent to pre-amendment devices
may be marketed through the 510(k) process until
FDA specifies PMA requirement
– New technology – automatically into Class III,
regardless of risk
9. 9
Ways to Market a Medical Device
• Premarket Approval (PMA) – for Class III devices
– FDA has 180 days to review the PMA and make a
determination of safety and effectiveness
– Usually requires clinical studies
• “510(k)” or “Premarket Notification” – for most
Class II and some Class I devices
– notify FDA 90 days prior to introducing a device into the US
market
– Must show “substantial equivalence” to a “predicate” device
• General Controls – if PMA or 510k not required, go
to market
10. 10
Investigational Device
Exemption (“IDE”)
• Needed to conduct clinical studies of devices in
most instances (there are exceptions)
• Three basic types
– Feasibility Study -- evaluate safety
– Pilot Study -- effectiveness and optimization of
clinical protocol
– Pivotal Study -- expanded study with finished device
and intended population
11. 11
IDE …
• Institutional Review Board (IRB) must review
and approve IDE
• IRB must make determination of significant risk
vs non-significant risk device
• Significant risk device -- one that presents a
potential risk to the health, safety, or welfare of
a human study subject. Includes devices used in
supporting or sustaining human life or
substantial importance in preventing impairment
13. 13
IDE …
• Examples of non-significant risk devices:
▪ Daily-wear contact lenses
▪ General hospital catheters
▪ MRIs within FDA specified parameters
▪ Limited classes of wound dressing
Listing of significant and non-significant risk devices is available in
“FDA Guidance for Institutional Review Boards and Clinical
Investigators”
14. 14
Premarket Approval Application
(“PMA”)
• Standard of Approval –
– “…valid scientific evidence …there is reasonable assurance
that the device is safe and effective…”
– “Valid scientific evidence is evidence from well-controlled
investigations …that there is reasonable assurance of the
safety and effectiveness of a device under its conditions of
use…”
• Two approaches to filing a PMA –
– Traditional PMA
• Full and complete filing in first instance
• Initially reviewed by FDA scientist and experts to determine whether
file is “administratively complete” and meets the requirements of 21
CFR Part 814, PMA is then officially filed
15. 15
PMA …
• Modular Approach
– Sponsor is responsible for PMA “shell” -- outline of
basic sections for PMA
– Mechanism for interaction of sponsor with agency
reviewers
– Breaks the PMA into well-delineated components,
stages or “modules”
– Module reports filed when testing and analysis of
particular module is complete
16. 16
PMA -- Changes
• Amendments: used to revise existing
information, prior to approval
• Supplement: changes that affect
safety or effectiveness of the existing
device such as intended use, labeling,
packaging, sterilization
–May require new clinical studies
17. 17
510(k)
• Device is substantially equivalent if in comparison to
predicate device, the new device has:
▪ same intended use as predicate
▪ same technological characteristics as predicate
▪ if new device has different technological characteristics:
▪ they do not raise new questions of safety and effectiveness; and
▪ sponsor demonstrates that new device is as safe and effective as
predicate
18. 18
510(k) & Substantial Equivalence
• Substantial equivalence (“SE”) does not mean
new device and predicate must be identical
• SE -- established relative to intended use, design,
energy used or delivered, materials, safety,
performance, effectiveness, labeling,
biocompatibility, standards and other applicable
characteristics
• Clinical studies -- about 10% of 510(k) need to
show SE
19. 19
510(k) …
• Who is required to submit --
▪ domestic manufactures introducing device to US
markets
▪ specification developers introducing device to US
markets
▪ repackers or relabelers who make a labeling change,
or whose operations significantly affect device
▪ foreign manufactures/exporters or US
representatives offoreign /exporters introducing a
device to US market
20. 20
Types of 510(k)
• Three types of 510(k) developed under “510(k)
Paradigm”
– Special 510(k)
• Limited to certain circumstances and must contain a
“Declaration of Conformity” with design control
requirements
• FDA intends to process special 510(k)s within 30 days of
DCO receipt
21. 21
Types of 510(k) …
• Abbreviated 510(k) - manufacturer may choose if one of the
following apply:
– Guidance document exist
– A special control has been established
– FDA has recognized a relevant consensus standard
• If relying on either a guidance document or special controls,
manufacturer must provide a summary that describes adherence
to such documents during development and testing of the
device.
• If relying on an FDA recognized standard, manufacturer must
include “Declaration of Conformity” to the recognized
standard
– About 400 standards to which submitter can declare conformity
22. 22
Types of 510(k) …
• Traditional 510(k) -- No specific 510(k) form but
there is an FDA suggested format
• Steps to preparing a Traditional 510(k)
– Find a predicate
– If applicable use Guidance Documents
– Prepare and format all contents
– Assemble 510(k)
• For more detailed information on preparing a
Traditional 510(k) --
http://www.fda.gov/cdrh/devadvice/3143.html
23. 23
Quality System Regulation
• Instituted because Good Manufacturing
Practices did not address “original design of
device”
• Needed pre-production design controls
• New authority given to FDA to require
manufacturers to have documented and
validated design controls for the production of
new devices
24. 24
User Fees
• First authorized in 2002 under the Medical
Device User Fee and Modernization Act
(MDUFMA)
• Reauthorized through FY 2012 by Food & Drug
Administration Amendments Act (“FDAAA”)
– PMA -- $185,000
– PMA-Supp: $27,750
– 510(k) -- $3,404
25. 25
Quality System Regulation
• Places focus on post-marketing as well as pre-
marketing activities
• Prior to QSR going into effect, 44% of quality
problems during a 6-year period attributed to
design related defects
26. 26
Quality System Inspection
Technique
• QSIT -- focuses on four major QS subsystems:
– Management Controls
– Design Controls
– Corrective and Preventive Actions (CAPA)
– Production and Process Controls
• For more information and guidance on Quality
System Regulation:
http://www.fda.gov/cdrh/comp/gmp.html
27. 27
Federal Device Hierarchy
President
HHS Secretary
FDA Commissioner
Center for Devices &
Radiological Health Director
Office of Regulatory Affairs
Office of Device Evaluation Local FDA District Office
Office of Compliance
Office of Surveillance
& Biometrics
Office of Compliance
Field Inspectors
28. 28
Resources
• Code of Federal Regulations (“CFR”) -- 21 Parts
800 to 1299 – Key provisions:
– 801 – Labeling
– 803 – Medical Device Reporting (“MDR”)
– 807 – Registration, Listing, and 510(k)
– 812 – IDE
– 814 – PMA
– 820 – QSR
– 822 – Postmarket Surveillance
– 860 – Classifications
• FDA Website -- http://www.fda.gov/cdrh/devadvice
29. 29
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
michael.swit@weinberggroup.com
www.weinberggroup.com
Questions?
30. 30
About your speaker…
Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the
execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. His
expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and
dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience
includes serving for three and a half years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of
FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the
FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug
Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced
FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored
by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his
law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.
31. 31
For twenty –five years, leading companies have
depended on THE WEINBERG GROUP when their
products are at risk. Our technical, scientific and
regulatory experts deliver the crucial results that get
products to market and keep them there.
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