Regulatory Reporting

Why MDR compliance matters

Under 21 CFR Part 803, FDA requires device user facilities, manufacturers, importers and distributors to report, or keep records of, device-related adverse events. These reports help FDA ensure that devices are not adulterated or misbranded and remain safe and effective for their intended use.

Part 803 sets out who reports, what counts as reportable, how fast reports are due, what each report must contain, and what records must be kept.

Who must report, and what each role owes FDA

• Device user facility: (hospital, ambulatory surgical facility, nursing home, outpatient diagnostic or treatment facility): reports deaths and serious injuries, but not malfunctions. Must keep adverse event files, maintain written MDR procedures and submit an annual report.
• Manufacturer: reports deaths, serious injuries and certain malfunctions. Must keep MDR event files, maintain written MDR procedures and submit supplemental and follow-up reports.
• Importer: reports deaths and serious injuries to FDA and the manufacturer, and certain malfunctions to the manufacturer. Must keep MDR event files and maintain written MDR procedures.
• Distributor: has no reporting obligation, but must maintain device complaint (incident) records.

Reporting timelines at a glance

User facilities

• Death: report to FDA and the manufacturer, if known, within 10 work days.
• Serious injury: report to the manufacturer within 10 work days, or to FDA if the manufacturer is unknown.
• Annual report on Form FDA 3419: due to FDA by January 1 each year.

Importers

• Death or serious injury: report to FDA and the manufacturer within 30 calendar days.
• Malfunction: report to the manufacturer within 30 calendar days.

Manufacturers

• Death, serious injury or reportable malfunction: report to FDA within 30 calendar days.
• Event needing remedial action to prevent an unreasonable risk of substantial harm to public health, or an event FDA requests in writing (5-day report): report to FDA within 5 work days.
• Supplemental or follow-up information not in the initial report: submit to FDA within 30 calendar days of receiving it.

All reports must be in English (§803.13). Manufacturers and importers must file electronically unless FDA grants an exemption (§803.11, §803.12).

The reports FDA receives are housed in the public MAUDE database (Manufacturer and User Facility Device Experience), and FDA may disclose them after removing trade secret and personal information (§803.9). FDA's TPLC database (Total Product Life Cycle) then brings those adverse event reports together with premarket (PMA and 510(k)) and recall data by device product code, so a manufacturer's MDRs are visible to anyone researching its device type. Learn more in FDA's pages on MAUDE and TPLC.