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61 FR 33244, June 26, 1996, unless otherwise noted.
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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]