FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on FDA or the public.” Nevertheless, for those interested in medical device reporting, the document is required reading as it collects and refines Agency positions and expectations on everything from adverse event reporting basics, to definitions, to procedures and timing.
One item of potential utility to device manufacturers involved in product liability litigation is this Q & A:
3.4 When I submit an MDR report, is the report considered an admission that my device caused or contributed to the reported event?
No, the submission of a report or related information to us and our release of that information is not necessarily an admission that you, your employees, or your device caused or contributed to the reportable event [21 CFR 803.16]. We have included such a disclaimer on FDAs [sic] public database, [MAUDE] – Manufacturer and User Facility Device Experience.
This notion — that submission of an MDR is not an admission that the device actually caused the reported adverse event — is not new, but it is good to see it restated in this Final Guidance nonetheless.