21 CFR 814.114 - Timeframes for reviewing an HDE.

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There are 2 Updates appearing in the Federal Register for 21 CFR 814. View below or at eCFR (GPOAccess)
§ 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 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