Timeframes for reviewing an HDE.

21 C.F.R. § 814.114
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
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).

Starting a business? Corpus forms LLCs in all 50 states and DC.