10400.1This 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.
10400.2This part supplements and does not supersede other provisions of this chapter, including the provisions of Chapter 107.
authority
Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.
source
Final Rulemaking published at 60 DCR 10252 (July 12, 2013).
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