View all text of Subpart H [§ 814.100 - § 814.126]
§ 814.114 - Timeframes for reviewing an HDE.
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).