(a)(1) FDA will issue to the requester an order granting a De Novo request if none of the reasons in paragraph (c) of this section for declining the De Novo request applies.

(2) If FDA grants a De Novo request, within 30 days after the issuance of an order granting the De Novo request, FDA will publish in the Federal Register a notice of the classification order, including any special controls.

(b) If FDA declines a De Novo request, FDA will issue a written order to the requester.

(c) FDA may decline a De Novo request if the requester fails to follow the requirements of this part or if, upon the basis of the information submitted in the De Novo request or any other information before FDA, FDA determines:

(1) The device does not meet the criteria under section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3 for classification into class I or II;

(2) The De Novo request contains a false statement of material fact or there is a material omission;

(3) The device's labeling does not comply with the requirements in parts 801 and 809 of this chapter, as applicable;

(4) The product described in the De Novo request does not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act and is not a combination product as defined at § 3.2(e) of this chapter;

(5) The device is of a type which has already been approved in existing applications for premarket approval (PMAs) submitted under part 814 of this chapter;

(6) The device is of a type that has already been classified into class I, class II, or class III;

(7) An inspection of a relevant facility under § 860.240(c) results in a determination that general or general and special controls would not provide reasonable assurance of safety and effectiveness;

(8) A nonclinical study subject to part 58 of this chapter that is described in the De Novo request, and that is essential to show there is reasonable assurance of safety, was not conducted in compliance with part 58 of this chapter and no reason for the noncompliance is provided or, if a reason is provided, the practices used in conducting the study do not support the validity of the study;

(9) A clinical investigation described in the De Novo request involving human subjects that is subject to the institutional review board regulations in part 56 of this chapter, informed consent regulations in part 50 of this chapter, or GCP described in § 812.28(a) of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable;

(10) A clinical or nonclinical study necessary to demonstrate that general controls or general and special controls provide reasonable assurance of safety and effectiveness:

(i) Has not been completed 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.