National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 60025 [2017-27128]
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
SUPPLEMENTARY INFORMATION:
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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 for
use based on performance
characteristics 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. Through the
approach described in the 2003
guidance, manufacturers established
sufficient control to maintain the level
of safety and effectiveness demonstrated
in 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)).
FDA believes this policy is important
for public health as it promotes more
timely availability of a wider array of
clinical laboratory tests for patient
benefit. To ensure that its full benefits
are realized, FDA is providing
additional clarity to help manufacturers
and FDA better apply the concepts in
the guidance.
This draft guidance, when finalized,
is intended to update and provide
clarity on the Replacement Reagent and
Instrument Family Policy for
manufacturers of IVD devices and FDA
staff. It incorporates concepts and
recommendations from FDA’s guidance
entitled ‘‘Deciding When to Submit a
510(k) for a Change to an Existing
Device,’’ issued on October 25, 2017 (82
FR 49375).
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This draft guidance is being issued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The draft guidance, when finalized, will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 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. 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of the draft guidance may do so by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
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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 ‘‘Replacement Reagent and
Instrument Family Policy for In Vitro
Diagnostic Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 16045 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidances. 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 21 CFR
part 820 are approved under OMB
control number 0910–0073; the
collections of information in 21 CFR
part 807, subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
parts 801 and 809 are approved under
OMB control number 0910–0485; the
collections of information in the
guidance document ‘‘Administrative
Procedures for CLIA [Clinical
Laboratory Improvement Amendments
of 1988] Categorization’’ are approved
under OMB control number 0910–0607;
and the collections of information for
requests for feedback on medical device
submissions in the guidance document
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
are approved under OMB control
number 0910–0756.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27132 Filed 12–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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60025
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Planning Grant (R34) and Implementation
Cooperative Agreement (U01).
Date: January 16, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institutes of Health/
NIAID, 5601 Fishers Lane, Rockville, MD
20852, 240–669–5026, haririmf@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 12, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–27128 Filed 12–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Page 60025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant
(R34) and Implementation Cooperative Agreement (U01).
Date: January 16, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: Maryam Feili-Hariri, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institutes of Health/NIAID, 5601 Fishers Lane,
Rockville, MD 20852, 240-669-5026, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: December 12, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-27128 Filed 12-15-17; 8:45 am]
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