Section 22-B10410. FILES AND DISTRIBUTOR RECORDS

 

10410.1A user facility, importer, or manufacturer shall establish and maintain MDR event files. The user shall clearly identify all MDR event files, and maintain them to facilitate timely access.

 

10410.2For purposes of this section, "MDR event files" are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references to other information (e.g., medical records, patient files, and engineering reports), in lieu of copying and maintaining duplicates in this file.  MDR event files must contain:

 

(a)Information in your possession or references to information related to the adverse event, including all documentation of your deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under this section; and

 

(b)Copies of all MDR forms, as required by this section, and other information related to the event that you submitted to us and other entities such as an importer, distributor, or manufacturer.

 

10410.3If you are a user facility, importer, or manufacturer, you must permit any authorized DOH employee, at all reasonable times, to access, copy, and verify the records required by this section.

 

10410.4A user facility shall retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this section.

 

10410.5If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, electronic, or oral communication, either received or generated by you, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness, or performance of a device. You must also maintain information about your evaluation of the allegations, if any, in the incident record. You must clearly identify the records as device incident records and file these records by device name. You may maintain these records in written or electronic format. You must back up any file maintained in electronic format.

 

10410.6A device distributor shall retain copies of the required device incident records for a period of two (2) years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater.  Copies of these records shall be maintained even if a device is no longer distributed.

 

10410.7A device distributor shall maintain the device complaint files established under this section at the principal business establishment. A manufacturer shall maintain the file at the same location where a complaint file is maintained under Chapter 107. Any authorized DOH employee shall, at all reasonable times, have access to copy or verify the records required by this section.

 

10410.8A manufacturer shall maintain MDR event files as part of your complaint file, under Chapter 107, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in Chapter 107.  You must document and maintain in your MDR event files an explanation of why you did not submit or could not obtain any information required by this part, as well as the results of your evaluation of each event.

 

 

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).