FDA Issues Draft Guidance on Reporting Of Adverse Events by Device Makers

The Food and Drug Administration July 8 asked for comments on a draft guidance on adverse event reporting and recordkeeping requirements for medical device manufacturers.

The agency said Medical Device Reporting for Manufacturers “describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.” FDA said its draft is intended to update FDA’s policy and to further clarify FDA’s interpretations of the requirements and, when final, will supersede the manufacturer guidances issued in 1988 and 1997.

This draft guidance also provides answers to frequently asked questions and ...