Document ID: FDA-2020-N-0011-0002
Agency: fda
Document Type: Rule
Title: Medical Devices; Technical Amendment
Posted Date: 2020-04-02T04:00Z

[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Rules and Regulations]
[Pages 18444-18445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06278]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862 and 866

[Docket No. FDA-2020-N-0011]

Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
certain medical device regulations to accurately reflect the devices 
exempted from premarket notification (510(k)) as indicated in the lists 
published on April 13, 2017, and July 11, 2017. FDA published a final 
amendment, final order in the Federal Register of December 30, 2019 
(``Final Order'') codifying the two Federal Register notices. The 
present revisions are necessary to correct editorial errors to ensure 
that the codified is consistent with the exemptions in the Federal 
Register notices. 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, 2020.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with sections 510(l)(2) and 510(m)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(l)(2) 
and 360(m)(1)(A)), FDA issued two separate notices of final 
determination exempting a list of class I and II devices from section 
510(k) of the FD&C Act, respectively, subject to certain limitations 
published in the Federal Register April 13, 2017 (82 FR 17841) and July 
11, 2017 (82 FR 31976). The devices included in these lists were exempt 
upon publication of the final determination notices in the Federal 
Register notices (see sections 510(l)(2)(A) and 510(m)(3) of the FD&C 
Act). On December 30, 2019 (84 FR 71794), FDA issued an amendment, 
final order, which amended the codified for the classification 
regulations implicated in the Federal Register notices to reflect the 
exemptions and limitations on exemptions in those notices. This Final 
Order incorrectly amended the codified for three device types such that 
the exemption in the current codified is inconsistent with the scope of 
the device exemptions described in the Federal Register notices. 
Specifically, for the three implicated device types, FDA indicated in 
the Federal Register notices that a device with a particular intended 
use was exempt from the premarket notification requirements in section 
510(k) of the FD&C Act; however, the codified currently indicates that 
the entire device type is exempt from section 510(k) of the FD&C Act, 
which is not the case.
    As such, FDA is amending the codified for Sec. Sec.  862.1345, 
862.1775, and 866.2900 (21 CFR 862.1345, 862.1775, and 866.2900) to be 
consistent with the exemptions as stated in the Federal Register 
notices. These amendments are not substantive changes because the 
Federal Register notices exempted the affected devices from the section 
510(k) of the FD&C Act, but are intended to correct the codified and to 
clarify which devices under those classification regulations are exempt 
from the premarket notification requirements in section 510(k) of the 
FD&C Act and which device types remain subject to such requirements.

II. Description of the Technical Amendments

    The regulations specified in this rule have been revised to correct 
and clarify the codified language of the regulations specified in this 
technical amendment, specifically Sec. Sec.  862.1345, 862.1775, and 
866.2900, to be consistent with the exemptions as stated in the Federal 
Register notices. FDA is making no substantive changes to the following 
regulations:
    1. FDA is revising Sec.  862.1345(b) by replacing ``The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9''

[[Page 18445]]

with ``The device, when it is solely intended for use as a drink to 
test glucose tolerance, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  862.9.''
    2. FDA is revising Sec.  862.1775 by replacing ``The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9'' with 
``The device, when it is solely intended for use as an acid reduction 
of ferric ion test, a phosphotungstate reduction test, a gasometric 
uricase test, an ultraviolet uricase test, or an oxygen rate uricase 
test, is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec.  
862.9.''
    3. FDA is revising Sec.  866.2900 by replacing ``The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  866.9'' with 
``The device, when solely intended for use in the collection of 
concentrated parasites from specimens and transport, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  866.9.''

III. Notice and Public Comment

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). 
Section 553 of the 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)(3)(B). 
FDA's revisions make technical or non-substantive changes that pertain 
solely to ensuring that the regulations accurately reflect the 
exemptions made by the Federal Register notices 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

21 CFR Part 862

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
862 and 866 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXIOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec.  862.1345, revise paragraph (b) to read as follows:

Sec.  862.1345  Glucose test system.

* * * * *
    (b) Classification. Class II (special controls). The device, when 
it is solely intended for use as a drink to test glucose tolerance, is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  862.9.

0
3. In Sec.  862.1775, revise paragraph (b) to read as follows:

Sec.  862.1775  Uric acid test system.

* * * * *
    (b) Classification. Class I (general controls). The device, when it 
is solely intended for use as an acid reduction of ferric ion test, a 
phosphotungstate reduction test, a gasometric uricase test, an 
ultraviolet uricase test, or an oxygen rate uricase test, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec.  862.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
4. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
5. In Sec.  866.2900, revise paragraph (b) to read as follows:

Sec.  866.2900  Microbiological specimen collection and transport 
device.

* * * * *
    (b) Classification. Class I (general controls). The device, when 
solely intended for use in the collection of concentrated parasites 
from specimens and transport, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec.  866.9.

    Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06278 Filed 4-1-20; 8:45 am]
 BILLING CODE 4164-01-P