[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11091-11093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03860]



[[Page 11091]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5570]


Recommendations for Clinical Laboratory Improvement Amendments of 
1988 Waiver Applications for Manufacturers of In Vitro Diagnostic 
Devices; Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Recommendations for 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver 
Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA 
has updated this guidance to implement the waiver improvements section 
of the 21st Century Cures Act (the Cures Act), which requires FDA to 
revise ``Section V. Demonstrating Insignificant Risk of an Erroneous 
Result--Accuracy'' of the guidance ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver 
Guidance'') that was issued on January 30, 2008. The remainder of the 
2008 CLIA Waiver Guidance, with exception of technical edits for 
consistency with the newly amended section V, has not been 
substantively changed. This final guidance provides additional and 
updated approaches for demonstrating that a test meets the statutory 
criteria for waiver and includes FDA's revised thinking regarding ``the 
appropriate use of comparable performance between a waived user and a 
moderately complex laboratory user to demonstrate accuracy.''

DATES: The announcement of the guidance is published in the Federal 
Register on February 26, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-5570 for ``Recommendations for Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Waiver Applications for 
Manufacturers of In Vitro Diagnostic Devices.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Recommendations for Clinical Laboratory Improvement Amendments of 
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro 
Diagnostic Devices'' to the Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002 or to the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to

[[Page 11092]]

assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3435, Silver Spring, MD 20993-0002, 240-402-6169 or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    This final guidance revises the guidance titled ``Recommendations 
for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver 
Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 
CLIA Waiver Guidance'') that was issued on January 30, 2008, to 
implement section 3057 of the Cures Act (Pub. L. 114-255), which 
requires FDA to revise ``Section V. Demonstrating Insignificant Risk of 
an Erroneous Result--Accuracy'' of the 2008 CLIA Waiver Guidance. The 
remainder of the 2008 CLIA Waiver Guidance, with exception of technical 
edits for consistency with the newly amended section V, has not been 
substantively changed. This update provides additional approaches for 
demonstrating that a test meets the criteria in 42 U.S.C. 263a(d)(3)(A) 
and includes FDA's revised thinking regarding ``the appropriate use of 
comparable performance between a waived user and a moderately complex 
laboratory user to demonstrate accuracy.''
    The Secretary of Health and Human Services has delegated to FDA the 
authority to determine whether particular tests are ``simple'' and have 
``an insignificant risk of an erroneous result'' under CLIA and thus 
are eligible for CLIA waiver (69 FR 22849, April 27, 2004). The Centers 
for Medicare & and Medicaid Services is responsible for oversight of 
clinical laboratories, which includes issuing Certificates of Waiver. 
CLIA requires that clinical laboratories obtain a certificate before 
accepting materials derived from the human body for laboratory tests 
(42 U.S.C. 263a(b)).
    The 2008 CLIA Waiver Guidance describes recommendations for device 
manufacturers about study design and analysis for CLIA Waiver by 
Application to support an FDA determination as to whether the device 
meets the statutory criteria for waiver.
    On November 29, 2017, FDA issued a draft guidance titled ``Select 
Updates for Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 Waiver Applications for Manufacturers of In Vitro 
Diagnostic Devices.'' This draft guidance proposed additional 
approaches for demonstrating that a test meets the criteria in 42 
U.S.C. 263a(d)(3)(A). On November 29, 2018, FDA issued a revised draft 
guidance by the same title, which appeared in the Federal Register of 
November 29, 2018 (83 FR 61391), after considering comments received on 
the draft guidance issued November 29, 2017. This document revises 
section V of the guidance ``Recommendations for Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Waiver Applications for 
Manufacturers of In Vitro Diagnostic Devices,'' issued on January 30, 
2008.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Recommendations for Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Waiver Applications for 
Manufacturers of In Vitro Diagnostic Devices.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at 
https://www.regulations.gov. Persons unable to download an electronic 
copy of ``Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 16046 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
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50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
54................................  Financial Disclosure       0910-0396
                                     by Clinical
                                     Investigators.
803...............................  Medical Device             0910-0437
                                     Reporting.
809...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``Recommendations for Clinical      CLIA Waiver                0910-0598
 Laboratory Improvement Amendments   Applications.
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices''.
``Administrative Procedures for     CLIA Categorizations       0910-0607
 Clinical Laboratory Improvement
 Amendments of 1988
 Categorization''.
``Requests for Feedback and         Q-submissions.......       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
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    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03860 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P