(a) FDA will begin substantive review of a De Novo request after the De Novo request is accepted under § 860.230. Within 120 days after receipt of a De Novo request or receipt of additional information that results in the De Novo request being accepted under § 860.230, FDA will review the De Novo request and send the requester an order granting the De Novo request under § 860.260(a) or an order declining the De Novo request under 860.260(b).

(b) A requester may supplement or amend a pending De Novo request to revise existing information or provide additional information.

(1) FDA may require additional information regarding the device that is necessary for FDA to complete the review of the De Novo request.

(2) Additional information submitted to FDA must include the reference number assigned to the original De Novo request and, if submitted on the requester's own initiative, the reason for submitting the additional information.

(c) Prior to granting or declining a De Novo request, FDA may inspect relevant facilities to help determine:

(1) That clinical or nonclinical data were collected in a manner that ensures that the data accurately represents the benefits and risks of the device; or

(2) That implementation of Quality System Regulation (part 820 of this chapter) requirements, in addition to other general controls and any specified special controls, provide adequate assurance that critical and/or novel manufacturing processes produce devices that meet specifications necessary to ensure reasonable assurance of safety and effectiveness.