Section 22-B10632. POST-APPROVAL REQUIREMENTS AND REPORTS

 

10632.1An HDE approved under this section shall be subject to the post-approval requirements and reports set forth under 21 C.F.R. § 1.83, et seq., as applicable, with the exception of § 10616.1(g). In addition, medical device reports submitted to the Department in compliance with the requirements of Chapter 104 shall also be submitted to the IRB of record.

 

10632.2In addition to the reports identified in § 10632.1, the holder of an approved HDE shall prepare and submit the following complete, accurate, and timely reports:
 

(a) An HDE applicant is required to submit reports in accordance with the approval order. Unless the Department specifies otherwise, any periodic report shall include:

 

(1) An update of the information required under § 10619.1 in a separately bound volume;

 

(2)An update of the information required under § 10620.2(b), (c), and (e);
 

(3) The number of devices that have been shipped or sold since initial marketing approval under this section and, if the number shipped or sold exceeds four thousand (4,000), an explanation and estimate of the number of devices used per patient. If a single device is used on multiple patients, the applicant shall submit an estimate of the number of patients treated or  diagnosed using the device together with an explanation of the basis for the estimate;

 

(4)Information describing the applicant's clinical experience with the device since the HDE was initially approved. This information shall include safety information that is known or reasonably should be known to the applicant, medical device reports made under Chapter 104, any data generated from the post-marketing studies, and information (whether published or unpublished) that is known or reasonably expected to be known by the applicant that may affect an evaluation of the safety of the device or that may affect the statement of contraindications, warnings, precautions, and adverse reactions in the device's labeling; and

 

(5)A summary of any changes made to the device in accordance with supplements submitted under § 10622. If information provided in the periodic reports, or any other information in the possession of the Department, gives the agency reason to believe that a device raises public health concerns or that the criteria for exemption are no longer met, the agency may require the HDE holder to submit additional information to demonstrate continued compliance with the HDE requirements.

 

10632.3An HDE holder shall maintain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRB's, as well as any other information that the IRB or the Department requests. Such records shall be maintained in accordance with the HDE approval order.

 

 

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).