[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