Federal Register - October 5, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
54843
TABLE 2SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF THE FINAL RULEContinued $ millions Units Primary estimate
Low estimate
High estimate
$0.09
0.08
Category
Qualitative
Costs:
Annualized Monetized $millions/year
Annualized Quantified
Year dollars
Discount rate percent
Period covered years
$0.01
0.01
$0.17
0.15
2019
2019
2019
2019
7
3
7
3
10
10
10
10
2019
2019
7
3
10
10
2019
2019
7
3
10
10
Notes
Clarification of the De Novo process for requesters. Potentially fewer incomplete submissions and faster introduction of medical devices.
Qualitative.
Transfers:
Federal Annualized Monetized $millions/
year.
From:
Other Annualized Monetized $millions/
year.
To:
From:
To:
Effects:
State, Local or Tribal Government: None.
Small Business: A small one-time administrative burden of up to $300 per year on each affected small entity.
Wages: None.
Growth: None.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule.
The full analysis of economic impacts is available in the docket for this final rule Ref. 20 and at https www.fda.gov/
about-fda/reports/economic-impactanalyses-fda-regulations.
VIII. Analysis of Environmental Impact We have determined under 21 CFR
25.34b and f that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are subject to review by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C.
35013521. The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions,
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searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
Title: Medical Device De Novo Classification Process OMB Control Number 09100844Revision.
Description: This final rule implements the medical device De Novo classification process under section 513f2 of the FD&C Act, which provides a pathway for certain new types of devices to obtain marketing authorization as class I or class II
devices, rather than remaining automatically designated as a class III
device, which would require premarket approval under the postamendments device classification section of the FD&C Act section 513f1.
On October 30, 2017, FDA issued a final guidance De Novo Program guidance Ref. 5 to provide recommendations on the process for the submission and review of a De Novo request. The information collections associated with the guidance are approved under OMB control number 09100844. We provide below a revised burden estimate for the De Novo classification process as described in this final rule.
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Section 860.200 this final rule renumbers proposed 860.201 as 860.200 explains the purpose of the De Novo Classification regulations and provides the applicability of a De Novo request submission. Sections 860.210
and 860.220 this final rule renumbers proposed 860.223 and 860.234 as 860.210 and 860.220 describe the format and content, respectively, of a De Novo request. Section 860.230 this final rule renumbers proposed 860.245 as 860.230 describes the conditions under which FDA may refuse to accept a De Novo request. Section 860.240b this final rule renumbers proposed 860.256b as 860.240b provides for supplemental, amendatory, or additional information for a pending De Novo request. Section 860.250a4 this final rule renumbers proposed 860.267a4 as 860.250a4
provides that a requester may submit a written notice to FDA that the De Novo request has been withdrawn.
Description of Respondents:
Respondents to the information collection are medical device manufacturers seeking to market medical device products that have been automatically designated as class III
under section 513f1 of the FD&C Act.
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