[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Rules and Regulations]
[Pages 17065-17066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 821
[Docket No. FDA-2021-N-0246]
Medical Devices; Technical Amendments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its medical device regulations to make an editorial
nonsubstantive change and replace a reference to an obsolete office
with updated information. The rule does not impose any new regulatory
requirements on affected parties. This action is editorial in nature
and is intended to improve the accuracy of the Agency's regulations.
DATES: This rule is effective April 1, 2021.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of
Policy, Center for Devices and Radiological Health, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5519, Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's Center for Devices and Radiological Health (CDRH) has
reorganized to create an agile infrastructure that can adapt to future
organizational, regulatory, and scientific needs (84 FR 22854, May 20,
2019; 85 FR 18439, April 2, 2020). The newly formed Office of Product
Evaluation and Quality (OPEQ) combined the former Office of Compliance,
the Office of Device Evaluation, the Office of Surveillance and
Biometrics, and the Office of In Vitro Diagnostics and Radiological
Health, with a focus on a Total Product Lifecycle (TPLC) approach to
medical device oversight. Within OPEQ there are Offices of Health
Technology that focus on the TPLC review of specific types of medical
devices as well as cross-cutting offices focusing on specific policy
and programmatic needs including the Office of Regulatory Programs and
the Office of Clinical Evidence and Analysis. As part of this technical
amendment, we are making changes to correct a reference to an obsolete
office and to correctly identify the positions with authority to make
decisions on exemptions and variances from tracking orders. This change
is nonsubstantive and editorial in nature.
II. Description of the Technical Amendments
The regulations specified in this rule have been revised to make a
non-substantive editorial change to correct ``Director of the Office of
Regulatory Program'' to ``Director or Principal Deputy Director of the
Office of Product Evaluation and Quality'' and replace a reference to
``Director, Office of Compliance'' with ``Director or Deputy Directors,
CDRH, or the Director or Principal Deputy Director of the Office of
Product Evaluation and Quality.'' The rule does not impose any new
regulatory requirements on affected parties. The amendments are
editorial in nature and should not be construed as modifying any
substantive standards or requirements.
III. Notice and Public Comment
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). Section
553 of the Administrative Procedure Act (APA) exempts ``rules of agency
organization, procedure, or practice'' from proposed rulemaking (i.e.,
notice and comment rulemaking) (5 U.S.C. 553(b)(3)(A)). Rules are also
exempt when an Agency finds ``good cause'' that notice and comment
rulemaking procedures would be ``impracticable, unnecessary, or
contrary to the public interest'' (5 U.S.C. 553(b)(3)(B)).
FDA has determined that this rulemaking meets the notice and
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA's
revisions make technical or non-substantive changes that pertain solely
to the CDRH reorganization and do not alter any substantive standard.
FDA does not believe public comment is necessary for these minor
revisions.
The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because the amendments do not impose
any new regulatory requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.
List of Subjects in 21 CFR Part 821
Imports, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR
part 821 is amended as follows.
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS
0
1. The authority citation for part 821 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371,
374.
0
2. In Sec. 821.2, revise paragraphs (b) introductory text and (c) to
read as follows:
Sec. 821.2 Exemptions and variances.
* * * * *
(b) A request for an exemption or variance shall be submitted in
the form of a petition under Sec. 10.30 of this chapter and shall
comply with the requirements set out therein, except that a response
shall be issued in 90 days. The Director or Deputy Directors, CDRH, or
the Director or Principal Deputy Director of the Office of Product
Evaluation and Quality, CDRH, shall issue responses to requests under
this section. The petition shall also contain the following:
* * * * *
(c) An exemption or variance is not effective until the Director or
Deputy Directors, CDRH, or the Director or Principal Deputy Director of
the Office of Product Evaluation and Quality,
[[Page 17066]]
CDRH, approves the request under Sec. 10.30(e)(2)(i) of this chapter.
Dated: March 25, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-06681 Filed 3-31-21; 8:45 am]
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