CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > SUBPART H—Humanitarian Use Devices (§814.100 to §814.126) > 814.114—Timeframes for reviewing an HDE.

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 ).

Code of Federal Regulations

[63 FR 59221, Nov. 3, 1998]