Site Feedback

Website Feedback

This contact form is only for website help or website suggestions. If you have questions or comments regarding a published document please contact the publishing agency. Comments or questions about document content can not be answered by OFR staff. Please do not provide confidential information or personal data.

Title 21

This content is from the eCFR and is authoritative but unofficial.

Displaying title 21, up to date as of 7/10/2026. Title 21 was last amended 7/09/2026.
view historical versions
  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter H —Medical Devices
  4. Part 803 —Medical Device Reporting
  5. Subpart A —General Provisions
  6. § 803.12
  • Table of Contents
  • Details
  • Print/PDF
  • Display Options
  • Subscribe
  • Timeline
  • Go to Date
  • Compare Dates
  • Published Edition
  • Developer Tools
eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

§ 803.12 How do I submit initial and supplemental or followup reports?

(a) Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review, and archive.

(b) User facilities that submit their reports and additional information to FDA electronically must use an electronic format that FDA can process, review, and archive. User facilities that submit their reports to FDA on paper must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 3500A. Each report must be identified (e.g., “User Facility Report” or “Annual Report”).

(c) If you are confronted with a public health emergency, this can be brought to FDA's attention by contacting FDA's Office of Crisis Management, Emergency Operations Center by telephone, 24-hours a day, at 301-796-8240 or toll free at 866-300-4374, followed by the submission of an email to: .

Note:

This action does not satisfy your obligation to report under part 803.

(d) You may submit a voluntary telephone report to the MedWatch office at 800-FDA-1088. You may also obtain information regarding voluntary reporting from the MedWatch office at 800-FDA-1088. You may also find the voluntary Form FDA 3500 and instructions to complete it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

eCFR Content