Document ID: FDA-2017-D-5625-0001
Agency: fda
Document Type: Notice
Title: Recommendations for Dual 510(k) and Clinical Laboratory Improvement
Amendments Waiver by Application Studies; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability
Posted Date: 2017-11-29T05:00Z

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56610-56612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25774]

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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Improvement Amendments Waiver by Application Studies; Draft Guidance 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the availability of the draft guidance entitled ``Recommendations for 
Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) 
Waiver by Application Studies.'' It describes study designs for 
generating data that supports both 510(k) clearance and CLIA waived 
categorization. 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 waived categorization in addition to 510(k) clearance 
for new In Vitro Diagnostic (IVD) devices. FDA believes increased use 
of this pathway will speed up the process of bringing simple and 
accurate IVD devices to CLIA waived settings, which will better serve 
patients and providers. This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by January 29, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 56611]]

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.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 21CFR 
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 Dual 510(k) and CLIA Waiver by Application 
Studies'' 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: Peter Tobin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5645, Silver Spring, MD 20993-0002, 240-402-6169.

SUPPLEMENTARY INFORMATION:

I. Background

    In an application for CLIA waived categorization (CLIA Waiver by 
Application) a manufacturer submits evidence to FDA that a test, 
initially categorized as moderate complexity, meets the CLIA statutory 
criteria for waiver, 42 U.S.C. 263a(d)(3), and requests that FDA 
categorize the test as waived. Historically, CLIA Waiver by Application 
has followed clearance or approval of an IVD test. This stepwise 
approach currently remains the most utilized path by manufacturers. For 
additional information, please see FDA's Guidance, ``Administrative 
Procedures for CLIA Categorization'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070889).
    While a premarket notification (510(k)) and CLIA Waiver by 
Application each include discrete elements not required in the other, 
both submissions include comparison and reproducibility studies. For a 
510(k), such studies are often performed by trained operators (i.e., 
laboratory professionals who meet the qualifications to perform 
moderate complexity testing and with previous training in performing 
the test; sometimes referred to as ``moderate complexity users''). For 
a CLIA Waiver by Application, such studies must be conducted by 
untrained operators (i.e., operators in waived settings with limited or 
no training or hands on experience in conducting laboratory testing; 
sometimes referred to as ``waived users'').
    An applicant may choose to conduct a single set of comparison and 
reproducibility studies with untrained operators to satisfy associated 
requirements for both 510(k) and CLIA Waiver by Application. 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 (MDUFA III), allowing the 
review of both a 510(k) and CLIA Waiver Application within a single 
submission with a reduced overall review time.
    This guidance leverages FDA's experience implementing this pathway 
in MDUFA III in order to make the Dual Submission pathway least 
burdensome. Use of this guidance is expected to reduce study-related 
costs and provide time savings for manufacturers of certain Class II 
IVD devices intended for CLIA waived settings.

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 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. 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

[[Page 56612]]

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 Dual 510(k) and CLIA Waiver by 
Application Studies'' may send an email request to [email protected] 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 draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR 54 have been approved under 0910-0396; the collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
control number 0910-0755, the collections of information in 21 CFR 807 
have been approved under 0910-0120; the collections of information in 
the guidance document entitled ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices'' have been approved 
under 0910-0598, the collections of information in the guidance 
document entitled ``Requests for Feedback on Medical Device 
Submissions'' have been approved under 0910-0756; and the collections 
of information in the guidance document entitled ``Administrative 
Procedures for Clinical Laboratory Improvement Amendments of 1988 
Categorization'' have been approved under 0910-0607.

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25774 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P