Biotility: Regulatory Approval for Medical Devices (United States)

Describes FDA’s regulatory controls for three common marketing approval pathways for the three classes of medical devices, and explains the Code of Federal Regulations that pertain to medical device approval in the United States.

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About this Course

This course provides an overview of the U.S. Food and Drug Administration’s (FDA) regulatory authority over medical devices and discusses key amendments to the Food, Drug and Cosmetic Act which govern the approval pathways of medical devices in the U.S.

The presenter explains the system for classification of medical devices in detail, with examples of types of medical devices in each class. Learners will gain an understanding of the three common pathways used by FDA to market safe medical devices, including no premarket evaluation, premarket notification (510(k)), and premarket approval processes. The course covers requirements of the Code of Federal Regulations, as well as general and special regulatory controls for each class of medical devices.

Other topics covered by this course include considerations for predicate devices and substantial equivalence, requirements for a 510(k) application and summary of content per 21 CFR §807.92, applicable regulatory controls that apply to Class III medical devices, and requirements for a Premarket Approval Application (PMA) per 21 CFR §814. This course also describes types of changes that impact filings and information required by FDA when changes are made to a premarket notification (510(k)) application per 21 CFR §807.81, and to a Premarket Approval Application, per 21 CFR §814.39.

Biotility: Regulatory Approval for Medical Devices (United States) course is tailored to the biotech industry service providers and personnel involved in manufacture and/or testing of medical devices in the United States. This includes, but is not limited to, personnel working with medical devices in: Manufacturing, Product Design, Process Design, Research and Development, Quality Assurance, Quality Control, Quality Management, Medical Device Marketing, or Management of Medical Device Operations.

Note: This Biotility at the University of Florida course is offered by CITI Program. See FAQs for more information.

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Language Availability: English

Suggested Audiences: Biotech industry service providers and personnel involved in manufacture and/or testing of medical devices in the United States, Personnel working with medical devices in manufacturing, product design, and process design as well as research and development, Personnel working with medical devices in quality assurance, quality control, quality management, medical device marketing, or management of medical device operations

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $124.75 per person

Demo Instructions


Course Content

Regulatory Approval for Medical Devices - Module 1

Module 1 provides an overview of FDA’s regulatory authority and key amendments to the Food, Drug, and Cosmetic Act which govern the approval pathways of medical devices in the U.S. The presenter reviews key terms and definitions and explains the  medical device classification system. Learners will about the three common pathways used by FDA to market safe medical devices and applicable regulatory controls per 21 CFR §807 and 21 CFR §820.

Recommended Use: Required
ID (Language): 20677 (English)
Author(s): Wayner Williams, CQA, MS - Medical Device and Pharmaceutical Consulting, Inc.

Regulatory Approval for Medical Devices - Module 2

This module reviews two of the three common pathways used by FDA to market safe medical devices, including no premarket evaluation and premarket notification (510(k)) processes. The module covers FDA requirements and regulatory controls for these pathways. The presenter explains considerations for predicate devices and substantial equivalence for premarket notification (510(k)). Further, the module includes requirements for a 510(k) application and summary of content per FDA regulations 21 CFR §807.92.

Recommended Use: Required
ID (Language): 20678 (English)
Author(s): Wayner Williams, CQA, MS - Medical Device and Pharmaceutical Consulting, Inc.

Regulatory Approval for Medical Devices - Module 3

Module 3 explains the general and special regulatory controls applicable to Class III medical devices and the premarket approval pathway. This includes requirements for a Premarket Approval Application (PMA), including making changes and supplements to a PMA based upon regulations in 21 CFR §814. This module also describes types of changes that impact filings and information required by FDA when changes are made to a premarket notification (510(k)) application per 21 CFR §807.81.

Recommended Use: Required
ID (Language): 20679 (English)
Author(s): Wayner Williams, CQA, MS - Medical Device and Pharmaceutical Consulting, Inc.


FAQs

Who should take the Regulatory Approval for Medical Devices course?

The Biotility: Regulatory Approval for Medical Devices (United States) course is tailored to biotech industry service providers and personnel involved in the manufacture and/or testing of medical devices in the United States. This includes, but is not limited to, personnel working with medical devices in:

  • Manufacturing
  • Product Design
  • Process Design
  • Research and Development
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Medical Device Marketing
  • Management of Medical Device Operations
  • Regulatory Compliance (FDA)

What are the benefits of this course?

Medical device manufacturers in the United States are required to understand and comply with federal mandates and Subchapter H of Title 21 of the Code of Federal Regulations. The Biotility: Regulatory Approval for Medical Devices (United States) industry training course provides an in-depth overview of medical device classification, examples of devices from each risk category, and details on the common pathways for regulatory approval to market medical devices. Learners in this course will understand the regulations and policies put in place by FDA for pre-market approval, manufacture, and post-marketing compliance for medical devices in the United States.

How long will the course take to complete?

The Biotility: Regulatory Approval for Medical Devices (United States) course consists of three modules. Completion of all modules, as well as the corresponding quizzes should take 165 to 210 minutes.