Timeframes for reviewing an HDE.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Premarket Approval of Medical Devices
  7. Humanitarian Use Devices
  8. Timeframes for reviewing an HDE.

Checkout our iOS App for a better way to browser and research.

§ 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]


Download our app to see the most-to-date content.