10609. TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION

10609 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). SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10609