1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
  6. Subpart H - Humanitarian Use Devices
  7. 21 CFR § 814.114
21 CFR § 814.114
Timeframes for reviewing an HDE
June 25, 2020
CFR

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]

Next
§ 814.116 Procedures for review of an HDE

Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.

Designed and built by Tekk Innovations LLC, the makers of the LawStack iPhone app or Android app.

© 2020 Tekk Innovations LLC