Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with RULES1

54830

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
Comment 4 A comment recommends FDA provide additional training for FDA reviewers on De Novo classification to assist FDA reviewers in more thoroughly understanding the devices and how to review De Novo requests with the broader view of assessing the nature of the devices and their value to the patient.
Response 4 FDA currently provides training to FDA staff on the De Novo classification process. With the publication of this final rule, FDA
intends to update its current training to be reflective of the requirements of the final rule. FDA also understands that patient input can be an important consideration during FDAs review of a De Novo request, as reflected in our guidance for industry and FDA Staff, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Ref. 3 and Patient Preference Information Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling Ref. 4.
Comment 5 A commenter proposes that unless required by the FD&C Act or the device is of high public health importance, FDA defer the identification of special controls for devices being granted De Novo classification until after the De Novo request is granted and FDA can make a general assessment of all class II
devices. The same commenter also requests that FDA prioritize the identification of special controls for all class II devices.
Response 5 Because special controls are necessary to assure the safety and effectiveness of class II devices, FDA
does not agree with the commenters proposal. FDA believes it is important to identify the appropriate special controls for class II devices at the time FDA
grants the De Novo request. The granting of the De Novo request does several things: It allows the device to be marketed immediately, creates a classification regulation for devices of the type, and permits the device to serve as a predicate device section 513f2B of the FD&C Act Ref. 5.
Because these consequences flow from the grant of a De Novo request, and because special controls are necessary to reasonably assure the safety and effectiveness of a class II device, FDA
will continue to identify special controls at the time that it grants a De Novo classification request.
The request that FDA prioritize the identification of special controls for all
VerDate Sep<11>2014

17:01 Oct 04, 2021

Jkt 256001

class II devices is outside the scope of this rulemaking.
Comment 6 A comment recommends that medical device applicants be encouraged to perform and/or review studies that address the effect of the device on patient function, because the commenter states that, for all populations, the ability to function at work, at home, and with family is an important outcome.
Response 6 Where relevant to the intended use of a device, FDA currently would take patient function into account in evaluating the safety and effectiveness of the device. As part of its initiative for patients to engage with FDA, FDA has incorporated patient perspectives into the total product life cycle, including in the premarket evaluation of devices Refs. 4 and 6.
Comment 7 A comment objects to the placement of all the De Novo request regulatory requirements in part 860 and suggests that the Center for Devices and Radiological Health CDRH separate requirements for the information needed to classify a device type from requirements for the information needed to authorize a specific low to moderate risk device for marketing by placing the latter in a separate regulation for Premarket Approval of Novel Class I
and II Medical Devices.
Response 7 FDA disagrees with this comment. The De Novo classification provisions will be housed in part 860 of the CFR with the other device classification subparts. We recognize that, because the De Novo classification process includes a pathway to obtain marketing authorization for a specific device, placement of the De Novo classification regulations may not be as straightforward as the other classification regulations. FDA believes that part 860 is the most appropriate fit.
Comment 8 A comment asserts that some devices, especially implantable devices, are inappropriately classified as class II instead of class III because these devices are potentially life-saving or life-threatening. The comment further indicates that the De Novo pathway should not replace the PMA pathway for implanted devices that are not eligible for 510k clearance and recommends that FDA document whether the increase in De Novo grants over the past few years indicates a movement from 510k clearance of devices to De Novo or from PMA review to the less stringent De Novo pathway before finalizing the proposed rule.
Response 8 Altering the statutory standards for device classification and marketing authorization is outside the scope of this rulemaking. FDA classifies devices according to the statutory
PO 00000

Frm 00030

Fmt 4700

Sfmt 4700

criteria set forth in section 513a1 of the FD&C Act. Therefore, if FDA
determines that general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness for a potentially lifesupporting device, FDA must classify that device into class II see section 513a1B of the FD&C Act. Congress added section 513f2 of the FD&C Act as part of FDAMA to limit unnecessary expenditure of FDA and industry resources that could occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness were subject to premarket approval under section 515 of the FD&C Act 21
U.S.C. 360e. As enacted by FDAMA, to submit a De Novo request, a device first had to be found NSE to legally marketed predicate devices through a 510k.
Section 513f2 of the FD&C Act was modified by section 607 of FDASIA, which created an alternative mechanism for submitting a De Novo request that does not require that a device be reviewed first under a 510k and found NSE prior to submission of a De Novo request. If a person believes their device is appropriate for classification into class I or class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510k and NSE.
Comment 9 A comment objects to making De Novo devices immediately available as a predicate device because the commenter suggests that it puts patient safety at risk and does not reward innovation. The commenter proposes a safe harbor of several years where the De Novo device cannot be used as a predicate.
Response 9 FDA disagrees with this comment. Section 513f2 of the FD&C
Act provides that any device classified through the De Novo pathway shall be a predicate device for determining substantial equivalence and does not impose a waiting period for such devices to be used as predicates.
C. Comments and FDA Response on Use of Advisory Committees and Bundling Devices Comment 10 A comment requests FDA to revise 860.1 to limit the use of advisory committees to cases of highrisk, life-supporting, or life-sustaining devices, or to classification panels because the commenter states that referring a De Novo request to an advisory committee should be unusual, as the devices that are the subject of such requests generally present low to moderate risk.

E:FRFM05OCR1.SGM

05OCR1