FDA 483 OBSERVATION · #19 OF 1,923 MOST-CITED
Lack of Written MDR Procedures
FDA cited this observation 863 times across 807 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
A device firm did not develop, maintain, and implement written Medical Device Reporting (MDR) procedures — the internal system for identifying, evaluating, and timely reporting to FDA the deaths, serious injuries, and malfunctions the device may have caused or contributed to.
Why FDA writes it — MDR is how FDA sees safety signals across the market. If a firm has no written procedure to recognize and report reportable events, serious device problems never reach the agency — so the missing procedure is itself a reportable-system failure.
- Develop, maintain, and implement written MDR procedures covering timely and effective identification, communication, and evaluation of events that may be reportable.
- Build a standardized reportability decision process and document the decision for each event, including events determined not reportable.
- Establish timely transmission of complete reports and keep MDR files and documentation of your deliberations.
- Integrate MDR with complaint handling so a reportable event surfaced as a complaint is screened and reported on time.
- Firms treat MDR as covered by complaint handling and never write the distinct procedure 803.17 requires.
- No documented reportability rationale, so “not reportable” calls cannot be defended and reportable events slip past the deadline.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.1× the rate of the average FDA-cited firm (8.8% vs 7.8%), across 807 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Written MDR procedures have not been implemented.
Written MDR procedures have not been developed.
Written MDR procedures have not been developed, maintained and implemented.
Written MDR procedures have not been developed, maintained and implemented.
Written MDR procedures have not been developed and implemented.
Written MDR procedures have not been developed and maintained.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →