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# Custom Device Annual Report Hints
- URL: https://www.fdaweb.com/custom-device-annual-report-hints/
- Published: 2018-03-08T12:00:00.000Z
- Updated: 2026-09-14T23:28:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140943

A CDRH Webinar gave hints to improve compliance with the custom device annual report requirements. A custom device exemption allows medical device manufacturers to market certain devices designed to treat a unique pathology or physiological condition without premarket approval. Manufacturers of custom devices are to report to FDA annually.

During the W[ebinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm595654.htm?ref=fdaweb.com), CDRH Office of Compliance jurisdictional officer **Kareem Burney** and consumer safety officer **Jamie Kamon-Brancazio** talked about some of the problems seen in annual reports and ways to improve their quality to help facilitate and improve the process for both industry and the agency.