§ 860.260 Granting or declining a De Novo request.
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Title 21 CFR: Food and Drugs › Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 860: MEDICAL DEVICE CLASSIFICATION PROCEDURES › Subpart D: De Novo Classification › § 860.260: § 860.260 Granting or declining a De Novo request.
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ted per the study protocol, or
(ii) Deficiencies related to the investigation and identified in any request for additional information under § 860.240(b)(1) have not been adequately addressed; or
(11) After a De Novo request is accepted for review under § 860.230(b), the requester makes significant unsolicited changes to the device's:
(i) Indications for use; or
(ii) Technological characteristics.
(d) An order declining a De Novo request will inform the requester of the deficiencies in the De Novo request, including each applicable ground for declining the De Novo request.
(e) FDA will use the criteria specified in § 860.7 to determine the safety and effectiveness of a device in deciding whether to grant or decline a De Novo request. FDA may use information other than that submitted by the requester in making such determination.
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