D.C. Mun. Regs. tit. 22, r. 22-B10609

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

Rule 22-B10609 - TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION

10609.1

Within one hundred eighty (180) days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, the Department will review the PMA and, after receiving the appropriate Department advisory committee's report and recommendations, send the applicant an approval order under 21 C.F.R. § 814.44(d)(1), an approvable letter under 21 C.F.R. § 814.44(e), a not approvable letter under 21 C.F.R. § 814.44(f)(1) or (2), or an order denying approval under 21 C.F.R. § 814.45. The approvable letter and the not approvable letter will provide an opportunity for the applicant to amend or withdraw the application, or to consider the letter to be a denial of approval of the PMA under 21 C.F.R. § 814.45 and to request administrative review under Sections 21 U.S.C. §§ 360e(d)(3) and (g).

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.