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Custom Devices

The custom device exemption​

Under FD&C Act § 520(b) [21 U.S.C. § 360j(b)], certain custom devices are exempt from the 510(k) and PMA requirements. A device qualifies as a custom device if it:

  1. Necessarily deviates from an otherwise applicable performance standard or requirement under section 514 or 515
  2. Is not generally available in finished form for purchase or for dispensing upon prescription
  3. Is not offered through labelling or advertising for commercial distribution
  4. Is intended for use by an individual patient named in the order of a physician or dentist
  5. Is assembled from components or manufactured and finished on a case-by-case basis solely to comply with such order

Record-keeping requirements​

Manufacturers of custom devices must maintain records and submit an annual report to FDA containing:

  • The number of custom devices manufactured per device type
  • The indications for use
  • The basis for the determination that the device qualifies as custom

Official resources​

Annual reports must be submitted to FDA by January 31st for the prior calendar year. Reports should be submitted to the appropriate CDRH division based on device classification and submitted either electronically via FDA's reporting system or by mail to CDRH.