[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Pages 50624-50626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6765]


Replacement Reagent and Instrument Family Policy for In Vitro 
Diagnostic Devices; 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 ``Replacement Reagent and 
Instrument Family Policy for In Vitro Diagnostic Devices.'' This 
guidance is intended to update and provide clarity on the replacement 
reagent and instrument family policy for manufacturers of in vitro 
diagnostic devices and FDA staff to promote consistent application of 
the concepts in this guidance. Specifically, it addresses a 
manufacturer's application of an assay that was previously cleared for 
use based on performance characteristics when used with a specified 
instrument

[[Page 50625]]

to an additional instrument that was previously cleared, or that is a 
member of an instrument family from which another member has been 
previously cleared. This document supersedes the final guidance 
``Replacement Reagent and Instrument Family Policy'' issued on December 
11, 2003.

DATES: The announcement of the guidance is published in the Federal 
Register on August 17, 2022.

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-6765 for ``Replacement Reagent and Instrument Family Policy 
for 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, 240-402-7500.
     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, 240-402-7500.
    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 
``Replacement Reagent and Instrument Family Policy for In Vitro 
Diagnostic Devices'' to the Office of Policy, 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: Scott McFarland, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3572, Silver Spring, MD 20993-0002, 301-
796-6217.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2003, FDA issued updated guidance on the ``Replacement Reagent 
and Instrument Family Policy'' for in vitro diagnostic (IVD) devices. 
The 2003 guidance described a mechanism for manufacturers to follow 
when applying an assay that was previously cleared based on performance 
characteristics when used with a specified instrument to an additional 
instrument that is either cleared or a member of an instrument family 
from which another instrument was previously cleared. Through the 
approach described in the 2003 guidance, manufacturers established 
sufficient control to maintain the level of safety and effectiveness 
demonstrated for the cleared device for these types of modified 
devices, when evaluated against predefined acceptance criteria using a 
proper validation protocol, without submission of a premarket 
notification (510(k)).
    This guidance is intended to update and provide clarity on the 
replacement reagent and instrument family policy for manufacturers of 
IVD devices and FDA staff to promote consistent application of the 
concepts in this guidance. Specifically, it addresses a manufacturer's 
application of an assay that was previously cleared for use based on 
performance characteristics when used with a specified instrument to an 
additional instrument that was previously cleared, or that is a member 
of an instrument family from which another member has been previously 
cleared. This document supersedes the final guidance ``Replacement 
Reagent and Instrument Family Policy'' issued on December 11, 2003.
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 18, 2017 (82 FR 60024). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including changing the scope of the guidance such 
that, in certain limited situations, point of care IVD devices could be 
within the scope of the guidance rather than being expressly identified 
as outside the scope

[[Page 50626]]

of the guidance, the addition of flowcharts, updates to examples, and 
further clarification of terminology.
    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 the replacement reagent and instrument 
family policy for 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.

II. 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 and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Replacement Reagent and Instrument 
Family Policy for 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 950 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidances have been 
approved by OMB as listed in the following table:

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                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
``Administrative Procedures for     CLIA Categorization.       0910-0607
 Clinical Laboratory Improvement
 Amendments (CLIA) of 1988
 Categorization''.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
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    Dated: August 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17643 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P