Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 50624-50626 [2022-17643]
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Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Notices
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BILLING CODE P
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
Food and Drug Administration,
HHS.
Tuesday, August 30,
2022 at 10 a.m. and its continuation at
the conclusion of the open meeting on
August 31, 2022.
PLACE: 1050 First Street NE,
Washington, DC and virtual (this
meeting will be a hybrid meeting).
STATUS: This meeting will be closed to
the public.
MATTERS TO BE CONSIDERED: Compliance
matters pursuant to 52 U.S.C. 30109.
Matters concerning participation in civil
actions or proceedings or arbitration.
*
*
*
*
*
CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer, Telephone:
(202) 694–1220.
TIME AND DATE:
17:22 Aug 16, 2022
Open Session
AGENCY:
Sunshine Act Meeting
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Kimberly Weaver, Director, Office of
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SUPPLEMENTARY INFORMATION:
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Dated: August 11, 2022
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[FR Doc. 2022–17693 Filed 8–16–22; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Jkt 256001
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
Notice of Board Meeting
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Telephonic. Dial-in (listen
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meetup-join/19%3ameeting_
MzZlNTRlZDYtNzRhZS00Z
jhlLThmNWItNmIwZmE2Zm
VkNzRl%40thread.v2/0?context=%
7b%22Tid%22%3a%223f6323b7-e3fd4f35-b43d-1a7afae5910d
%22%2c%22Oid%22%3a%227
c8d802c-5559-41ed-9868-8bfad5d44
af9%22%7d.
DATES:
ADDRESSES:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
ACTION:
Notice of availability.
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
SUMMARY:
E:\FR\FM\17AUN1.SGM
17AUN1
Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Notices
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’’).
JSPEARS on DSK121TN23PROD with NOTICES
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
VerDate Sep<11>2014
17:22 Aug 16, 2022
Jkt 256001
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-201509-18/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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
50625
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed 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
E:\FR\FM\17AUN1.SGM
17AUN1
50626
Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Notices
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
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:
OMB control
No.
21 CFR part; guidance; or FDA form
Topic
807, subpart E ............................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
800, 801, and 809 ......................................................................
‘‘Administrative Procedures for Clinical Laboratory Improvement Amendments (CLIA) of 1988 Categorization’’.
820 ..............................................................................................
Premarket notification .................................................................
Q-submissions ............................................................................
0910–0120
0910–0756
Medical Device Labeling Regulations ........................................
CLIA Categorization ...................................................................
0910–0485
0910–0607
Current Good Manufacturing Practice (CGMP); Quality System
(QS) Regulation.
0910–0073
Dated: August 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
questions to be posed to the advisory
committee at the hearing.
The hearing will be held
virtually October 17 to 19, 2022,
beginning at 8 a.m. Eastern Time on
each day and concluding at 4 p.m. on
Days 1 and 2 and 12:30 p.m. on Day 3.
Either electronic or written comments
on the hearing must be submitted by
November 3, 2022.
DATES:
[FR Doc. 2022–17643 Filed 8–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Proposal To Withdraw Approval of
MAKENA; Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of hearing.
The Food and Drug
Administration (FDA, Agency, or we)
has granted a hearing on the Center for
Drug Evaluation and Research’s
(CDER’s) proposal to withdraw approval
of MAKENA (hydroxyprogesterone
caproate injection, 250 milligrams (mg)
per milliliter (mL), once weekly), new
drug application (NDA) 021945, held by
Covis Pharma Group/Covis Pharma
GmbH (Covis). This notice provides
information and details regarding the
hearing, including the time, date, and
format of the hearing, as well as the
SUMMARY:
VerDate Sep<11>2014
17:22 Aug 16, 2022
Jkt 256001
The docket number for this
matter is FDA–2020–N–2029. The
docket will close on November 3, 2022.
Either electronic or written comments
on this hearing must be submitted by
November 3, 2022. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time on November
3, 2022. Comments received by mail/
hand delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date. Comments received on or before
October 11, 2022, will be provided to
the advisory committee for
consideration.
You may submit comments as
follows:
ADDRESSES:
[Docket No. FDA–2020–N–2029]
JSPEARS on DSK121TN23PROD with NOTICES
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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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 CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 950 and
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
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’’).
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
------------------------------------------------------------------------
OMB control
21 CFR part; guidance; or FDA form Topic No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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
