[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P


