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.
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: $124.76 per person