A bill to amend the Federal Food, Drug, and Cosmetic Act to require manufacturers, importers, and distributors of medical devices to maintain certain records respecting the handling of complaints, analysis of device failures, and the return of devices.

Amends the Federal Food, Drug, and Cosmetic Act to require manufacturers, importers, and distributors of medical devices to maintain certain records respecting procedures for the handling of complaints, analysis of device failures, and the return of devices.