FDA Draft Guidance Provides Definitions, Recommendations For Custom Devices-thegraysheet: A new FDA draft guidance (PDF) on custom device exemptions provides industry with definitions for custom devices, explains how FDA plans to interpret regulatory language that limits production to “five units per year of a particular device type,” and provides recommendations for information to be included in annual reports. The Jan. 13 guidance was mandated by the FDA Safety and Innovation Act of 2012, which included a new provision amending an existing custom device exemption. Manufacturers rely on the exemption in limited cases to create or modify a version of a device to meet a doctor’s or a patient’s specific needs without submitting a PMA to FDA.
