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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
under section 513f2 of the Federal Food, Drug, and Cosmetic Act or does not contain each of the items required under this part, or a justification for omission of any item;
iii The De Novo request is not formatted as required under 860.210;
iv The De Novo request is for multiple devices and those devices are of more than one type; or v The requester has not responded to, or has failed to provide a rationale for not responding to, deficiencies identified by FDA in previous submissions for the same device, including those submissions described in 860.220a3.
2 If FDA refuses to accept a De Novo request, FDA will notify the requester of the reasons for the refusal. The notice will identify the deficiencies in the De Novo request that prevent accepting and will include the De Novo request reference number.
3 If FDA refuses to accept a De Novo request, the requester may submit the additional information necessary to comply with the requirements of section 513f2 of the Federal Food, Drug, and Cosmetic Act and this part. The additional information must include the De Novo request reference number of the original submission. If the De Novo request is subsequently accepted, the date of acceptance is the date FDA
receives the additional information.

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860.240 Procedures for review of a De Novo request.

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 860.260a or an order declining the De Novo request under 860.260b.
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 requesters 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:

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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.
860.250
request.

Withdrawal of a De Novo
a FDA considers a De Novo request to have been withdrawn if:
1 The requester fails to provide a complete response to a request for additional information pursuant to 860.240b1 within 180 days after the date FDA issues such request;
2 The requester fails to provide a complete response to the deficiencies identified by FDA pursuant to 860.230c2 within 180 days of the date notification was issued by FDA;
3 The requester does not permit an authorized FDA employee an opportunity to inspect the facilities, pursuant to 860.240c, at a reasonable time and in a reasonable manner, and to have access to copy and verify all records pertinent to the De Novo request; or 4 The requester submits a written notice to FDA that the De Novo request has been withdrawn.
b If a De Novo request is withdrawn, the Agency will notify the requester.
The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.
860.260
request.

Granting or declining a De Novo
a1 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:

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1 The device does not meet the criteria under section 513a1 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 devices 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 201h of the Federal Food, Drug, and Cosmetic Act and is not a combination product as defined at 3.2e 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 860.240c 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 812.28a 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 860.240b1 have not been adequately addressed; or
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