FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R. Part 803. These actions were disclosed in a recent official FDA blog post from Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH). The Part 803 regulations require user facilities, such as hospitals, to have written procedures to ensure the submission of reports no more than 10 work days after the facility becomes aware of information reasonably suggesting that a medical device has, or may have, caused or contributed to a death or serious injury to a patient. User facilities are not required to determine if a medical device malfunctioned or failed to meet its specifications. Reports of medical device-related deaths must be submitted to FDA and the manufacturer, whereas reports of medical device-related serious injuries need only be submitted to the manufacturer; however, even these reports must be submitted to FDA if the manufacturer is not known. In addition, medical device report event files must be maintained, which are subject to FDA inspection, including documentation of the deliberations and decision making.

In December 2015, FDA initiated inspections of 17 hospitals in the wake of events related to infections associated with contaminated duodenoscopes or spread of uterine cancer following the use of morcellators. At the end of these inspections, 15 of 17 hospitals were issued a Form FDA 483 with the listing of inspectional observations of noncompliance with the regulations. The FDA post includes a table with a listing of all inspected hospitals and links to each FDA Form 483 that was issued and the deficiencies that were identified.