Jan 14, 2014

The US Food and Drug Administration has published draft guidance on how to comply with custom device exemption rules for products intended to treat extremely rare conditions or diseases.

Custom device exemptions were originally laid out in the US Food, Drug and Cosmetics Act, and then changed under the Food and Drug Administration Safety and Innovation Act of 2012. The new guidance is meant to address ongoing questions regarding implementation of and compliance with the exemptions.

The new guidance includes the following components:

  • Devices developed or modified based on orders from individual healthcare professionals
  • Multiple units (no more than five per year) of a custom device may qualify for exemption
  • Annual reporting requirements for manufacturers of custom devices

Manufacturers whose devices qualify for custom device exemptions generally do not have to meet FDA premarket clearance or approval requirements such as Premarket Approval (PMA) reviews.

The FDA is accepting comments on its custom device exemption guidance through March 17, 2014.

Stewart Eisenhart


  • Stewart Eisenhart