Section 22-B10616. POST-APPROVAL REQUIREMENTS

 

10616.1The Department may impose post-approval requirements in a PMA approval order or regulation at the time of approval of the PMA or by regulation subsequent to approval. Post-approval requirements may include as a condition to approval of the device:

 

(a) Restriction of the sale, distribution, or use of the device as provided by 21 U.S.C. §§ 360e(d)(1)(B)(ii) or 360j(e);

 

(b) Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use.  The Department  will state in the PMA approval order the reason or purpose for such requirement and the number of patients to be evaluated and the reports required to be submitted;

 

(c)Prominently display on the labeling of a device and in the advertising of any restricted device of warnings, hazards, or precautions important for the device's safe and effective use, including patient information (for example, information provided to the patient on alternative modes of therapy and on risks and benefits associated with the use of the device);
 

(d)Inclusion of identification codes on the device or its labeling, or in the case of an implant, on cards given to patients if necessary to protect the public health;

 

(e)Maintenance of records that will enable the applicant to submit to the Department information needed to trace patients if such information is necessary to protect the public health. The Department will require that the identity of any patient be disclosed in records maintained under this paragraph only to the extent required for the medical welfare of the individual, to determine the safety or effectiveness of the device, or to verify a record, report, or information submitted to the agency;

 

(f)Maintenance of records for specified periods of time and organization and indexing of records into identifiable files to enable DOH to determine whether there is reasonable assurance of the continued safety and effectiveness of the device;

 

(g)Submission to the Department at intervals specified in the approval order of periodic reports containing the information required by § 10617.2;
 

(h)Batch testing of the device; or

 

(i) Such other requirements as the Department determines are necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device.

 

10616.2An applicant shall grant to the Department access to any records and reports required under the provisions of this chapter, and shall permit authorized Department employees to copy and verify such records and reports and to inspect at a reasonable time and in a reasonable manner all manufacturing facilities to verify that the device is being manufactured, stored, labeled, and shipped under approved conditions.

 

10616.3Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA.

 

 

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).