Regulatory Approval for Medical Devices

The Food and Drug Administration is responsible for ensuring medical devices are safe and effective for their intended uses before they are marketed within the US. This course provides an overview of FDA’s regulatory authority and key amendments to the Food, Drug & Cosmetic Act, which govern the approval pathways of medical devices in the US today. Participants will gain an understanding of the different pathways used by FDA to market safe medical devices, including both the 510(k) and pre-market approval processes. Finally, the types of changes that can impact filings—and the information required by the FDA when changes are made—will be explored.

Suggested audiences include 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; and personnel working with medical devices in quality assurance, quality control, quality management, medical device marketing, or management of medical device operations