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 published on 2012-04-01
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