Keller and Heckman’s Food and Drug attorneys, in collaboration with our in-house scientists, counsel clients on global medical device laws and regulations, from premarket approval processes, including designing clinical studies when necessary, to advertising and promotion requirements to continuing compliance requirements to enforcement matters. We assist clients with compliance issues under U.S. Food and Drug Administration (FDA) regulations, such as how to classify medical devices (I, II, or III) and preparation of premarket notifications (510(k)s), applications for premarket approval (PMA), Humanitarian Device Exemptions (HDEs), Biologics License Applications (BLAs), De Novo Classifications requests, and Device Master Files (MAF), in addition to related requirements in countries around the world.
Our attorneys provide guidance regarding good manufacturing practices (GMPs), the Quality System Regulation (QSR), Medical Device Reports (MDRs) (Part 803), and Reports of Corrections and Removals (Part 806). We advise clients on FDA inspection practices, recalls and market withdrawals, and how to respond to Warning Letters and other actual or threatened enforcement actions. Keller and Heckman’s Food and Drug attorneys counsel both finished device manufacturers and component suppliers on product liability issues and, when necessary, defend them in related court cases.
- Counseled medical device manufacturers and raw material and component suppliers on risk management strategies to limit potential liability, including protections available under the Biomaterials Access Assurance Act of 1998