21 CFR 814.114 - Timeframes for reviewing an HDE.

§ 814.114 Timeframes for reviewing an HDE.

Within 75 days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, FDA shall send the applicant an approval order, an approvable letter, a not approvable letter (under § 814.116), or an order denying approval (under § 814.118).

[ 63 FR 59221, Nov. 3, 1998]

Title 21 published on 09-Jun-2018 03:51

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

  • 2018-02-21; vol. 83 # 35 - Wednesday, February 21, 2018
    1. 83 FR 7366 - Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective February 21, 2019. See section III of this document for additional explanation of the effective date of this final rule.
      21 CFR Parts 807, 812, and 814
The section you are viewing is cited by the following CFR sections.