21 CFR 814.40 - Time frames for reviewing a PMA.

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§ 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)(3) and (g) of the act.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-01-10; vol. 79 # 7 - Friday, January 10, 2014
    1. 79 FR 1735 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 10, 2014.
      21 CFR Part 814

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 814 after this date.

  • 2014-01-10; vol. 79 # 7 - Friday, January 10, 2014
    1. 79 FR 1735 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 10, 2014.
      21 CFR Part 814