§814.114. Timeframes for reviewing an HDE.
21 C.F.R. § 814.114
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).
Notes, amendments, and revision history
Amendments
[63 FR 59221, Nov. 3, 1998]
Source
Source: 61 FR 33244, June 26, 1996, unless otherwise noted.
Authority
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.
Amendments
[63 FR 59221, Nov. 3, 1998]