[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11089-11090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5625]


Recommendations for Dual 510(k) and Clinical Laboratory 
Improvement Amendments Waiver by Application Studies; 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 
Dual 510(k) and CLIA Waiver by Application Studies.'' It describes 
study designs for generating data that may support both 510(k) 
clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver. 
Use of the Dual 510(k) and CLIA Waiver by Application pathway is 
optional; however, FDA believes this pathway is in many instances the 
least burdensome and fastest approach for manufacturers to obtain a 
CLIA waiver at the same time as 510(k) clearance for new in vitro 
diagnostic (IVD) tests. FDA believes increased use of this pathway will 
speed up the process of bringing simple and accurate IVD tests to CLIA-
waived settings, which will better serve patients and providers.

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-5625 for ``Recommendations for Dual 510(k) and CLIA Waiver 
by Application Studies.'' 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 Dual 510(k) and CLIA Waiver by Application 
Studies'' to the Office of

[[Page 11090]]

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. 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 
Ave., Bldg. 66, Rm. 3435, Silver Spring, MD 20993-0002, 240-402-6169.

SUPPLEMENTARY INFORMATION: 

I. Background

    Typically, in an application for CLIA waiver (CLIA Waiver by 
Application) a manufacturer submits evidence to FDA that a previously 
cleared or approved test, initially categorized as moderate complexity, 
meets the CLIA statutory criteria for waiver (see 42 U.S.C. 263a(d)(3)) 
and requests that FDA categorize the test as waived. This means that 
historically a CLIA Waiver by Application has followed clearance or 
approval of an IVD test.
    While a premarket notification (510(k); 21 U.S.C. 360(k)) and CLIA 
Waiver by Application each include discrete elements not required in 
the other, both submissions generally include comparison and 
reproducibility studies. For a 510(k), such studies are often performed 
by trained operators (i.e., test operators who meet the qualifications 
to perform moderate complexity testing; sometimes referred to as 
``moderate complexity users''). For a CLIA Waiver by Application, we 
believe such studies should be conducted by the intended user (i.e., 
test operators in waived settings and with limited or no training or 
hands-on experience in conducting laboratory testing; sometimes 
referred to as ``untrained operators'' or ``waived users'') (see 42 
U.S.C. 263a(d)(3)).
    An applicant may choose to conduct a single set of comparison and 
reproducibility studies with untrained operators to satisfy certain 
requirements to establish both substantial equivalence under section 
513(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)) 
for 510(k) clearance and simplicity and insignificant risk of erroneous 
results under 42 U.S.C. 263a(d)(3) for CLIA waiver. To streamline the 
review of such data, the Dual 510(k) and CLIA Waiver by Application 
(Dual Submission) pathway was established as part of the Medical Device 
User Fee Amendments of 2012, allowing the review of both a 510(k) and 
CLIA Waiver by Application within a single submission with a reduced 
overall review time compared to separate, sequential submissions.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of November 29, 2018 (83 FR 61387). 
FDA revised the guidance as appropriate in response to the comments.

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 Dual 510(k) and CLIA 
Waiver by Application Studies.'' 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. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Recommendations for Dual 510(k) and CLIA Waiver by 
Application Studies'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16038 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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807, subpart E....................  Premarket                  0910-0120
                                     notification.
``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. 2020-03859 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P


