Page 78 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 57

(b) If you are an importer, you must submit reports as follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you
become aware of a reportable event:
(i) Submit reports of device-related deaths or serious injuries to FDA and to the manufacturer;
or
(ii) Submit reports of device-related malfunctions to the manufacturer.
(c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to FDA, as
follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you
become aware of a reportable death, serious injury, or malfunction.
(2) Submit reports of individual adverse events no later than 5 work days after the day that you
become aware of:
(i) A reportable event that requires remedial action to prevent an unreasonable risk of substan-
tial harm to the public health, or
(ii) A reportable event for which we made a written request.
(3) Submit annual baseline reports.
(4) Submit supplemental reports if you obtain information that you did not submit in an initial report.
Id. § 803.10.

This massive data collection exercise has resulted in a huge database of events. Because it is so
immense and the data so varied, it has not been as useful as Congress hoped. Attempts have been
made by FDA to get better reports, but the mass of data continues to grow. It is difficult for FDA to
craft an enforcement program that catches every required report, without inducing companies to
over-report just to avoid FDA confrontation.