Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 803 - MEDICAL DEVICE REPORTING
Subpart B - GENERALLY APPLICABLE REQUIREMENTS FOR INDIVIDUAL ADVERSE EVENT REPORTS
Section 803.23 - Where can I find information on how to prepare and submit an MDR in electronic format?

21 C.F.R. § 803.23

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Current through November 30, 2024
Section 803.23 - Where can I find information on how to prepare and submit an MDR in electronic format?
(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.

21 C.F.R. §803.23