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 ).
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.114 Timeframes for reviewing an HDE
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FDA guidance that cites § 814.114
- Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff 26 Nov 2024
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff 16 Dec 2019
- Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff 6 Sept 2019
- Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff 17 Dec 2018
Amendment history
Federal Register documents that created or amended this section.
- 63 FR 59221 3 Nov 1998