Document ID: FDA-2017-D-5625-0011
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Amendments Waiver by Application Studies; Draft Guidance for Industry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: 2018-11-29T05:00Z

[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61387-61388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25960]

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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Improvement Amendments Waiver by Application Studies; Draft Guidance 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the availability of the draft guidance entitled ``Recommendations for 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 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 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 This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 27, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download

[[Page 61388]]

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. 5657, 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, 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)) 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 and with previous training in performing 
the test; sometimes referred to as ``moderate complexity users''). For 
a CLIA Waiver by Application, we believe such studies need to 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 FD&C 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 (MDUFA III), 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 sequential submissions.

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 at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 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 [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 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:

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 21 CFR part; guidance; or FDA
             form                       Topic           OMB Control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
``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 CLIA 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. 2018-25960 Filed 11-28-18; 8:45 am]
 BILLING CODE 4164-01-P