21 C.F.R. § 814.40
Time frames for reviewing a PMA
Within 180 days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order under § 814.44(d), an approvable letter under § 814.44(e), a not approvable letter under § 814.44(f), or an order denying approval under § 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 § 814.45 and to request administrative review under section 515 (d)(4) and (g) of the act.
Notes of Decisions
Cited in 3
cases, 1995–2020 · leading case: prod.liab.rep. (Cch) P 14,158 Dorothy Marie Reeves v. Acromed Corp., Acromed Corp., 44 F.3d 300 (5th Cir. 1995).
prod.liab.rep. (Cch) P 14,158 Dorothy Marie Reeves v. Acromed Corp., Acromed Corp., 44 F.3d 300 (5th Cir. 1995). “21 C.F.R. § 814.40 . In contrast to the FDA’s Pre-Market Approval process, the agency’s Pre-Market Notification process is more abbreviated and involves less FDA oversight.”
Fender v. Medtronic, Inc., 887 F. Supp. 1326 (E.D. Cal. 1995). “21 C.F.R. § 814.40 . In contrast ... the agency’s Pre-Market Notification process is more abbreviated and involves less FDA oversight.”
Coghill v. Bayer Corp. (E.D. Ky. 2020). “at 319 ; 21 C.F.R. § 814.40 . This includes the device’s packaging and labeling.”
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