§ 804.1 - Scope.

(a) FDA is requiring medical device distributors to report deaths, serious illnesses, and serious injuries that are attributed to medical devices. Distributors are also required to report certain device malfunctions and to submit a report to FDA annually certifying the number of medical device reports filed during the preceding year, or that no reports were filed. These reports enable FDA to protect the public health by helping to ensure that devices are not adulterated or misbranded and are otherwise safe and effective for their intended use. In addition, device distributors are required to establish and maintain complaint files or incident files as described in § 804.35, and to permit any authorized FDA employee at all reasonable times to have access to, and to copy and verify, the records contained in this file. This part supplements, and does not supersede, other provisions of this subchapter, including the provisions of part 820 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.