5.05. US Medical Devices – Is My Product an FDA-Regulated Medical Device?

This course has been prepared by Neil O’Flaherty who heads the Medical Device Practice Group at Amin Wasserman Gurnani LLP (www.awglaw.com). As part of his U.S. FDA medical device regulatory practice, he assists clients in determining whether their products are actively regulated medical devices or whether they are not actively regulated devices or non-devices. For clients with actively regulated medical devices, he assists them with understanding and implementing the applicable U.S. FDA regulatory controls. Neil is a frequent speaker for industry conferences, seminars, and educational training programs.

• Statutory definition of “device”
• Intended use
• Not all items affecting a body structure or function are regulated as devices
• Medical device classification
• Exclusions from the definition of “device” or active regulation by FDA
• Transition of laboratory-developed tests into active regulation

Course duration: 40 min