§ 814.114. Timeframes for reviewing an HDE.
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/us/cfr/t21/s§ 814.114·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]