§ 814.114 Timeframes for reviewing an HDE.

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Title 21 CFR: Food and Drugs › Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 814: PREMARKET APPROVAL OF MEDICAL DEVICES › Subpart H: Humanitarian Use Devices › § 814.114: § 814.114 Timeframes for reviewing an HDE.

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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]

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