10400 GENERAL

10400.1 This section establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. A device user facility shall report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. A manufacturer or importer shall report deaths and serious injuries that its device has or may have caused or contributed to, shall report certain device malfunctions, and shall establish and maintain adverse event files. A manufacturer shall also submit specified follow-up. These reports help the Department to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. A medical device distributor shall maintain records (files) of incidents, but is not required to report these incidents.

10400.2 This part supplements and does not supersede other provisions of this chapter, including the provisions of Chapter 107.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).