Quiero saber acerca de...

54842

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
regulation for combination products include application of a risk-based approach and coordination among Centers for their review and regulation.
Review of combination products in a De Novo classification request would consider safety and effectiveness questions relating to the combination product as a whole, each constituent part, interactions between them, and user/patient interaction with the product.
Comment 58 A comment asks FDA
to clarify that while a De Novo request may be appropriate for the device constituent part of a combination product where the constituent parts of the combination product are distributed separately e.g., 3.2e3 through 4, and the non-device drug or biologic constituent part is to be marketed under its own, separate application, the nondevice constituent part must be appropriately labeled for use with the device constituent part i.e., approved at doses, concentrations, routes of administration, indications, and adequate instructions for use. The commenter notes that if the non-device constituent part is not appropriately labeled for use with the device constituent part, then FDA would cause the non-device constituent party to be adulterated or misbranded.
Response 58 FDA does not agree that clarification is necessary. Per 3.2e, the labeling of the constituent parts of such cross-labeled combination products specify use only with the other approved individually specified constituent parts, which are required to achieve the intended use, indication, or effect. The labeling for the combination product is comprised of the labeling for each constituent part.
Comment 59 A comment requests that FDA consider co-packaged combination products per 3.2e2
that have a device primary mode of action as eligible for the De Novo classification process.
Response 59 Regarding inclusion of co-packaged combination products as
defined in 3.2e2 that have a device primary mode of action, FDA does not believe further clarification is warranted in the codified because 860.260 this final rule renumbers proposed 860.289
as 860.260 explains that we are using the definition of combination products in 3.2e1 through 4. Co-packaged combination products as defined in 3.2e2 that have a device primary mode of action are part of this definition and eligible for the De Novo classification process.
VI. Effective Date This final rule will become effective 90 days after the date of publication in the Federal Register.
VII. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act 5 U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995 Pub. L. 1044. Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity. We believe that this final rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities.
Because small entities affected by this final rule would incur very low onetime costs to read and understand the rule, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 section 202a requires us to prepare a written statement, which includes an assessment of anticipated
costs and benefits, before issuing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any one year.
The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product.
This final rule would not result in an expenditure in any year that meets or exceeds this amount.
The final rule will clarify the De Novo classification process for certain medical devices to obtain marketing authorization as class I or class II
devices, rather than remaining automatically designated as class III
devices under the FD&C Act. In addition, the final rule will clarify and create a more efficient De Novo classification process by specifying: 1
What medical devices are eligible for the De Novo classification process; 2
what information manufacturers must provide in De Novo requests; and 3
how to organize this information. By clarifying and making the process more efficient, the final rule could reduce the time and costs associated with reviewing De Novo requests. Moreover, the final rule will allow us to refuse to accept inappropriate and deficient De Novo requests and require us to protect the confidentiality of certain data and information submitted with a request until we issue an order granting the request.
Industry will incur costs to read and understand this final rule. We estimate that the annualized costs over 10 years would range from $0.01 million to $0.17
million at a 7 percent discount rate, with a primary estimate of $0.09
million. We estimate that the annualized costs over 10 years at a 3
percent discount rate would range from $0.01 million to $0.15 million, with a primary estimate of $0.08 million.

TABLE 2SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF THE FINAL RULE
$ millions
lotter on DSK11XQN23PROD with RULES1

Units Category
Primary estimate
Low estimate
High estimate
Benefits:
Annualized
Monetized $millions/year
Annualized Quantified

VerDate Sep<11>2014

17:01 Oct 04, 2021

Jkt 256001

PO 00000

Frm 00042

Fmt 4700

Year dollars
Sfmt 4700

2019
2019
2019
2019

Discount rate percent
Period covered years
7 3
7 3

E:FRFM05OCR1.SGM

10
10
10
10

05OCR1

Notes