82 FR 56607 - 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Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has developed this draft guidance to implement a section of the 21st Century Cures Act (Cures Act) that requires FDA to revise ``V. Demonstrating Insignificant Risk of an Erroneous Result--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 This draft guidance updates FDA's thinking regarding the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56607-56609]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25775]


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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In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Select Updates for 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 
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic 
Devices.'' FDA has developed this draft guidance to implement a section 
of the 21st Century Cures Act (Cures Act) that requires FDA to revise 
``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 
updates FDA's thinking regarding the appropriate use of comparable 
performance between a waived user and a moderately complex laboratory 
user to demonstrate accuracy. 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 January 29, 2018 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 ``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

[[Page 56608]]

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.thefederalregister.org/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 
``Recommendations for Clinical Laboratory Improvement Amendments of 
1988 (CLIA) 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. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Marina Kondratovich, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 
301-796-6036; or Peter Tobin, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5657, Silver Spring, MD 20993-0002, 301-796-6169.

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 ``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 updates FDA's 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.
    FDA will incorporate the updates of the final version of this draft 
guidance into ``V. Demonstrating Insignificant Risk of an Erroneous 
Result--Accuracy'' of the 2008 CLIA Waiver Guidance. The remainder of 
the 2008 CLIA Waiver Guidance will not be changed by this update and 
will remain in effect.
    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 are 
thus eligible for waiver categorization (69 FR 22849, April 27, 2004). 
The Centers for Medicare & Medicaid Services (CMS) 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)). Laboratories that perform only 
tests that are ``simple'' and that have an ``insignificant risk of an 
erroneous result'' may obtain a certificate of waiver (42 U.S.C. 
263a(d)(2)).
    CLIA, 42 U.S.C. 263a(d)(3) Examinations and Procedures, as modified 
by the Food and Drug Administration Modernization Act of 1997 (FDAMA), 
reads as follows regarding tests that may be performed by laboratories 
with a Certificate of Waiver:

    ``The examinations and procedures [that may be performed by a 
laboratory with a Certificate of Waiver] . . . are laboratory 
examinations and procedures that have been approved by the Food and 
Drug Administration for home use or that, as determined by the 
Secretary, are simple laboratory examinations and procedures that 
have an insignificant risk of an erroneous result, including those 
that--(A) employ methodologies that are so simple and accurate as to 
render the likelihood of erroneous results by the user negligible, 
or (B) the Secretary has determined pose no unreasonable risk of 
harm to the patient if performed incorrectly.''

    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 described above. This update 
provides additional details and pathways for demonstrating that a test 
has an insignificant risk of erroneous result which is a key element 
for obtaining a CLIA Waiver by Application.
    In developing this specific update, we have considered interactions 
with stakeholders since the issuance of the final guidance on January 
30, 2008.

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 
``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. This draft 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. Guidance 
documents are 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 GUD1627 to identify the 
guidance you are requesting.

[[Page 56609]]

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
this guidance were approved under OMB control number 0910-0598. The 
collections of information in 21 CFR part 54 have been approved under 
0910-0396, and the collections of information in 21 CFR parts 50 and 56 
have been approved under OMB control number 0910-0755.

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25775 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P