21 CFR 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).

[ 63 FR 59221, Nov. 3, 1998]
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Title 21 published on 2015-12-03.

No entries appear in the Federal Register after this date, for 21 CFR Part 814.