21 C.F.R. § 814.114
Current through September 30, 2024
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 C.F.R. §814.114