21 C.F.R. § 814.114 Timeframes for reviewing an HDE.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart H—Humanitarian Use Devices
§ 814.114 Timeframes for reviewing an HDE.
