About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[1]
 
 

Electronic Code of Federal Regulations

e-CFR Data is current as of October 22, 2014

Title 21Chapter ISubchapter HPart 803Subpart A → §803.12


Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions


§803.12   Where and how do I submit reports and additional information?

(a) You 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.

(b) You must specifically identify each report (e.g., “User Facility Report,” “Annual Report,” “Importer Report,” “Manufacturer Report,” “10-Day Report”).

(c) If an entity is confronted with a public health emergency, this can be brought to FDA's attention by contacting the FDA Office of Emergency Operations, Office of Crisis Management, Office of the Commissioner, at 866-300-4374, followed by the submission of an e-mail to emergency.operations@fda.hhs.gov or a fax report to 301-847-8544.

(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 MEDWATCH 3500 form and instructions to complete it at http://www.fda.gov/medwatch/getforms.htm.

[70 FR 9519, July 13, 2005, as amended at 71 FR 1488, Jan. 10, 2006; 75 FR 32659, June 9, 2010]



For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.