21 CFR § 814.114 Premarket Approval of Medical Devices

§ 814.114 Timeframes for reviewing an HDE.

Current through Sep 8, 2026 · Read all of Part 814

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]

← § 814.112 Filing an HDE.§ 814.116 Procedures for review of an HDE. →