FDA Regulation for Medical Devices (revised)

The Medical Device Primer series provides the most efficient means of acquiring the background knowledge necessary to “hit the ground running” as a new engineer, sales/marketing associate, product manager, or supervisor in the medical device industry. Information from leading industry publications, industry insiders, website resources, and textbooks has been streamlined into single, concise, cohesive primers on five different topics. Where space does not allow for complete coverage of a topic, links to the best source available for further information are provided.

The FDA Regulation issue of Medical Device Primer covers the FDA as a whole; the Center for Disease and Radiological Health (CDRH) within the FDA; device classification; regulatory pathways including 510(k), PMA, HDE, emergency use, and compassionate use; postmarket requirements; and device labeling.