D.C. Mun. Regs. tit. 22, r. 22-B10617

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10617 - REPORTS

10617.1

The holder of an approved PMA shall comply with the requirements in Chapter 104 and with any other requirements applicable to the device by other regulations in this section or by order approving the device.

10617.2

Unless the Department specifies otherwise, any periodic report shall:

(a) Identify changes described in § 10608.1 and changes required to be reported to the Department under § 10608.2; and

(b) Contain a summary and bibliography of the following information not previously submitted as part of the PMA:

(1) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant;

(2) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, the Department concludes that the agency needs a copy of the unpublished or published reports, the Department will notify the applicant that copies of such reports shall be submitted; or

(3) Identify changes made pursuant to an exception or alternative under 21 C.F.R. § 801.128 or 21 C.F.R. § 809.11.

D.C. Mun. Regs. tit. 22, r. 22-B10617

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

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.