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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations there is no legally marketed device upon which to base a determination of substantial equivalence SE.
FDA will classify devices according to the classification criteria in the FD&C
Act. FDA classifies devices into class I
general controls if there is information showing that the general controls of the FD&C Act are sufficient to reasonably assure safety and effectiveness; into class II special controls if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III premarket approval if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or lifesupporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.
Devices will be classified by FDA
by written order.
A De Novo request includes administrative information, regulatory history, device description,
classification summary information, benefits and risks of device use, and performance data to demonstrate reasonable assurance of safety and effectiveness.
FDA may refuse to accept a De Novo request that is ineligible or that is not sufficiently complete to permit a substantive review.
After a De Novo request is accepted, FDA will begin a substantive review of the De Novo request that may result in either FDA requesting additional information, issuing an order granting the request, or declining the De Novo request.
FDA may decline a De Novo request if, among other things, the device is ineligible or insufficient information is provided to support De Novo classification.
The rule also describes our practices for the conditions under which the confidentiality of a De Novo file is maintained.
C. Legal Authority This rule is being issued under the device definition provision of the FD&C
Act, the combination products provision of the FD&C Act, the device
classification section of the FD&C Act, the De Novo classification section of the FD&C Act, the general rulemaking section of the FD&C Act, and the inspection section of the FD&C Act.
D. Costs and Benefits The final rule clarifies 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. A more transparent De Novo classification process could improve the efficiency of obtaining marketing authorization for certain novel medical devices. The medical device industry will incur onetime costs to read and understand this rule. Over 10 years, the annualized cost estimates a 7 percent discount rate range from $0.01 million to $0.17 million, with a primary estimate of $0.09
million. The annualized costs over 10
years at a 3 percent discount rate range from $0.1 million to $0.15 million, with a primary estimate of $0.08 million.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
Abbreviation or acronym
What it means
510k
CDRH
CFR
EUA
FDA
FD&C Act
FDAMA

Premarket Notification Center for Devices and Radiological Health Code of Federal Regulations Emergency Use Authorization Food and Drug Administration Federal Food, Drug, and Cosmetic Act Food and Drug Administration Modernization Act of 1997
Freedom of Information Act Federal Register Good Laboratory Practice Humanitarian Device Exemption Investigational Device Exemption Information Collection Information Collection Request Not Substantially Equivalent Office of Management and Budget Protected Health Information Premarket Approval Application Paperwork Reduction Act of 1995
Public Law Quality System Regulation Reference Requests for Designation under 21 CFR 3.7 3.7
Substantially Equivalent Summary of Safety and Effectiveness Data United States Code
FOIA
FR
GLP
HDE
IDE
IC
ICR
NSE
OMB
PHI
PMA
PRA
Pub. L.
QSR
Ref.
RFD
SE
SSED
U.S.C.

III. Background lotter on DSK11XQN23PROD with RULES1

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A. Need for the Regulation/History of This Rulemaking In the Federal Register on December 7, 2018 83 FR 63127, FDA issued a proposed rule entitled Medical Device De Novo Classification Process and
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requested comments on the proposed rule by March 7, 2019. This rule establishes procedures and criteria for the submission and withdrawal of a De Novo request. It also establishes procedures and criteria for FDA to accept, review, grant, and/or decline a De Novo request.

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B. Summary of Comments to the Proposed Rule FDA received comments on the proposed rule from several entities, including medical device associations;
industry, medical and healthcare professional associations; public health
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