[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61391-61393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25959]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Select Updates for Recommendations for Clinical Laboratory 
Improvement Amendments of 1988 Waiver Applications for Manufacturers of 
In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Select Updates for 
Recommendations for Clinical Laboratory Improvement Amendments of 1988 
Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' 
FDA has developed this draft guidance to implement the 21st Century 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. This draft guidance represents FDA's 
current thinking regarding ``the appropriate use of comparable 
performance between a waived user and a moderately complex laboratory 
user to demonstrate accuracy.'' The 2008 CLIA Waiver Guidance remains 
in effect, in its current form, until this draft guidance is finalized, 
at which time the updates in section III of this draft guidance will 
supersede the recommendations in section V of the 2008 CLIA Waiver 
Guidance. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 27, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 ``Select Updates for Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 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.gpo.gov/fdsys/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 draft guidance document entitled 
``Select Updates for Recommendations for Clinical Laboratory 
Improvement Amendments of 1988 Waiver Applications for Manufacturers of 
In Vitro Diagnostic Devices'' to the Office of the Center Director, 
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 the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to 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

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Ave., Bldg. 66, Rm. 5657, Silver Spring, MD 20993-0002, 240-402-6169; 
and 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

    FDA has developed this draft guidance 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 guidance ``Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices'' \1\ (``2008 CLIA Waiver Guidance'') that was 
issued on January 30, 2008. This draft guidance represents FDA's 
current thinking regarding ``the appropriate use of comparable 
performance between a waived user and a moderately complex laboratory 
user to demonstrate accuracy.'' The 2008 CLIA Waiver Guidance remains 
in effect, in its current form, until this draft guidance is finalized, 
at which time the updates in section III of this draft guidance will 
supersede the recommendations in section V of the 2008 CLIA Waiver 
Guidance.
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    \1\ https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070890.pdf.
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    FDA will incorporate the final version of this draft guidance into 
``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, will not be substantively changed and 
will remain in effect.
    The Secretary of Health and Human Services has delegated to FDA (69 
FR 22849, April 27, 2004) 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 (42 U.S.C. 
263a(d)(3)). The Centers for Medicare & 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 (42 U.S.C. 263a(d)(3)).
    On November 29, 2017, FDA announced in the Federal Register a draft 
guidance entitled ``Select Updates for Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 Waiver Applications for 
Manufacturers of In Vitro Diagnostic Devices'' (82 FR 56607). This 
draft guidance proposed additional approaches for demonstrating that a 
test meets the criteria in 42 U.S.C. 263a(d)(3)(A). FDA is issuing a 
revised draft guidance by the same title, after considering comments 
received on the draft guidance issued November 29, 2017.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Select 
Updates for Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 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. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Select Updates for Recommendations for 
Clinical Laboratory Improvement Amendments of 1988 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 draft 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. 3501-3520). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB Control 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.
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Recommendations for Clinical  CLIA Waiver                    0910-0598
 Laboratory Improvement          Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
``Administrative Procedures     CLIA Categorizations.          0910-0607
 for Clinical Laboratory
 Improvement Amendments of
 1988 Categorization''.
``Requests for Feedback on      Q-submissions........          0910-0756
 Medical Device Submissions:
 The Pre-Submission Program
 and Meetings with Food and
 Drug Administration Staff''.
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    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25959 Filed 11-28-18; 8:45 am]
 BILLING CODE 4164-01-P