The Custom Device Exemption: What Is It And Does It Ever Apply?

September 8, 2009

Congress carefully defined the term “custom devices” in 1976, but questions about the meaning of that term have persisted ever since.

A recent court case provided an opportunity to clarify the scope of the custom device exemption, for a device that qualifies as a custom device is exempt from FDA premarket clearance or approval.

Additional information available here.