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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR803.12]
See Related Information on Where and how do I submit reports and additional information? in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 803 -- MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec. 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]

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