{"data":{"id":"us/21-cfr-803.10","jurisdiction":"us","citation":"21 CFR 803.10","heading":"Generally, what are the reporting requirements that apply to me?","body":"(a) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:\n(1) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:\n(i) Submit reports of device-related deaths to us and to the manufacturer, if known, or\n(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.\n(2) Submit annual reports (described in § 803.33) to us.\n(b) If you are an importer, you must submit reports (described in subpart D of this part), as follows:\n(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:\n(i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or\n(ii) Submit reports of device-related malfunctions to the manufacturer.\n(2) [Reserved]\n(c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:\n(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.\n(2) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:\n(i) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or\n(ii) A reportable event for which we made a written request.\n(3) Submit supplemental reports if you obtain information that you did not submit in an initial report.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f074a49d584c85da7e59b6a18379505bb302836e2cb9a1ec7a13e3cf1da340d1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-803.9","next":"us/21-cfr-803.11"},"notice":"GroundRules: Original legal text. Not legal advice."}