21 CFR § 803.23 Medical Device Reporting

§ 803.23 Where can I find information on how to prepare and submit an MDR in electronic format?

Current through Sep 8, 2026 · Read all of Part 803

⚠ 2 pending changes to Part 803

(a) You may obtain information on how to prepare and submit reports in an electronic format that FDA can process, review, and archive at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.

(b) We may sometimes update information on how to prepare and submit reports electronically. If we do make modifications, we will ensure that we alert reporters by updating the eMDR Web page.

← § 803.22 What are the circumstances in which I am not required to file a report?§ 803.30 If I am a user facility, what reporting requirements apply to me? →