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

§ 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: emergency.operations@fda.hhs.gov.

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.

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