FDA Regulatory Practice

Medical Devices

We work closely with our medical device clients to advise the proper classification of devices, and have assisted clients in obtaining market authorization through the premarket approval application (PMA) and premarket notification (510[k]) process. We have assisted clients with a wide variety of compliance and enforcements issues, including good manufacturing practice/quality system (QS) regulation matters; establishment registration and device listing; product recalls or market withdrawals; U.S. FDA inspection practices; responding to Warning Letters and other actual or threatened enforcement actions; and advising on device promotion and advertising boundaries. Our attorneys have experience with a wide variety of medical devices, including traditional products as well as with in-vitro diagnostics, software devices and mobile medical apps, and combination drug/device products.

Our FDA litigation attorneys regularly provide counseling on product liability issues for finished device manufacturers and component suppliers and defending related court cases. We have forged relationships with various non-legal FDA consultants who assist clients to prepare premarket notifications (510[k]s) and applications for premarket approval (PMAs) in the U.S.