An FDA final rule adds a new requirement that to qualify for a custom device exemption, a device must treat a rare condition for which clinical investigations would be impractical.
The rule also states that production of a custom device must be limited to no more than five units per year and that manufacturers must report to the FDA annually on the custom devices they supplied.
The FDA noted that a device that meets the qualification of a custom device is exempt from 510(k) and premarket approval submissions. The changes in the definition were triggered by amendments in 2012 to the FD&C Act. — Jeff Kinney