89 FR 249 pgs. 106512-106513 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
Type: NOTICEVolume: 89Number: 249Pages: 106512 - 106513
Pages: 106512, 106513Docket number: [Docket No. FDA-2024-N-2149]
FR document: [FR Doc. 2024-31014 Filed 12-27-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2149]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by January 29, 2025.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0844. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
De Novo Classification Process (Evaluation of Automatic Class III Designation)-21 CFR Part 860, Subpart D
OMB Control Number 0910-0844-Revision
This information collection supports FDA regulations and information collection discussed in associated guidance. Sections 201(h), 513(a) and (f), 701(a), and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h), 360c(a) and (f), 371(a), and 374) establish a comprehensive system for the regulation of medical devices intended for human use. Section 513(f)(2) of the FD&C Act provides for a "De Novo" classification process, most recently amended by section 3101 of the 21st Century Cures Act (Pub. L. 114-255). The final rule "Medical Device De Novo Classification Process" (86 FR 54826), established part 860, subpart D (21 CFR part 860, subpart D) (§§?860.200 through 860.260) to implement provisions in section 513(f)(2) of the FD&C Act. These regulations govern format and content elements for De Novo device classification requests, as well as withdrawal of the requests, and explain FDA procedures for acceptance, review, and granting or denying a request.
FDA's guidance for industry and FDA staff, "De Novo Classification Process (Evaluation of Automatic Class III Designation)", provides guidance on the process for the submission and review of a De Novo classification request under section 513(f)(2) of the FD&C Act, also known as the De Novo classification process. This process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
In addition to regulatory requirements set forth in part 860, subpart D, the guidance document entitled "Acceptance Review for De Novo Classification Requests" communicates our thinking on criteria set out in §?860.230, in assessing whether a De Novo request should be accepted for substantive review. The guidance document includes an "Acceptance Checklist" to assist respondents in this regard.
The guidance document "Electronic Submission Template for Medical Device De Novo Requests," provides the standards for the submission of De Novo requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
The collections of information described by this notice are necessary to satisfy the previously mentioned statutory requirements for administration of this voluntary submission program. FDA uses the information to evaluate whether a medical device may be reclassified from class III into class I or II and, if applicable, to determine the general and/or special controls necessary to sufficiently regulate the medical device. Respondents to this information collection are private sector or other for-profit businesses.
In the Federal Register of May 29, 2024 (89 FR 46402), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
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| 21 CFR part 860, subpart D; information collection activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| §§?860.210, 860.220, 860.230; De Novo requests-format, content, and acceptance elements | 79 | 1 | 79 | 182 | 14,378 |
| §?860.230; FDA acceptance of request ( GFI Acceptance Checklist; Appendix A)? 1 | 79 | 1 | 79 | ||
| §?860.250; withdrawal of request | 5 | 1 | 5 | 0.17 (10 mins.) | 1 |
| Total | 14,379 | ||||
| 1 ?FDA assumes activities associated with review of the Acceptance Checklist are included in burden for submission of requests captured in row 1. | |||||
Our estimated burden for the information collection reflects an overall increase of 2,002 hours and a corresponding increase of 11 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Since the publication of the 60-day notice, we issued the guidance document entitled "Electronic Submission Template for Medical Device De Novo Requests" (August 23, 2024, 89 FR 68166; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests ) and are including it in this information collection. Given that all submissions were previously received electronically and the ability to voluntarily submit De Novo requests using eSTAR was included in the previous information collection request (ICR), inclusion of the guidance in this ICR is not expected to impact the estimated burden.
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31014 Filed 12-27-24; 8:45 am]
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