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.
D.C. Mun. Regs. tit. 22, r. 22-B10400