Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Multivariate Index Assays; Availability, 41081-41083 [07-3660]
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Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Cell Selection Devices for
Point of Care Production of Minimally
Manipulated Autologous Peripheral
Blood Stem Cells (PBSCs)’’ dated July
2007. The draft guidance document
discusses certain cell selection devices
that minimally manipulate autologous
PBSCs at the point of care for specific
clinical indications, and the
applicability of the requirements of 21
CFR part 1271 to such PBSCs. The
guidance also discusses the submission
of data intended to support approval of
cell selection devices.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
rwilkins on PROD1PC63 with NOTICES
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
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 812 have
been approved under 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
0910–0231; the collections of
information in 21 CFR part 820 have
been approved under 0910–0073; and
the collections of information in 21 CFR
part 822 have been approved under
0910–0449.
16:36 Jul 25, 2007
Jkt 211001
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–3659 Filed 7–23–07; 12:02 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0347]
Draft Guidance for Industry and Food
and Drug Administration Staff; In Vitro
Diagnostic Multivariate Index Assays;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
entitled ‘‘In Vitro Diagnostic
Multivariate Index Assays.’’ FDA is
issuing this revised draft guidance to
address the definition and regulatory
status of a class of In Vitro Diagnostic
Devices referred to as In Vitro
Diagnostic Multivariate Index Assays
(IVDMIAs). The revised draft guidance
also addresses premarket and
postmarket requirements with respect to
IVDMIAs. The initial draft of this
guidance was issued September 7, 2006.
DATES: Submit written or electronic
comments on this draft guidance by
August 27, 2007.
PO 00000
Frm 00033
Fmt 4703
Submit written requests for
single copies of the draft guidance
document entitled ‘‘In Vitro Diagnostic
Multivariate Index Assays’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850 or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist that office in processing your
request, or fax your request to 240–276–
3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the draft guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Courtney Harper, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0694.
For further information concerning
the guidance as it related to devices
regulated by CBER: Martin Ruta, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–3518.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
ACTION:
II. Paperwork Reduction Act of 1995
VerDate Aug<31>2005
III. Comments
41081
Sfmt 4703
I. Background
In the Federal Register of September
7, 2006 (71 FR 52800). FDA published
a notice of availability of the initial draft
guidance to address the definition and
regulatory status of a class of in vitro
diagnostic devices referred to as ‘‘In
Vitro Diagnostic Multivariate Index
Assays (IVDMIAs).’’ The initial draft
guidance also addressed premarket and
postmarket requirements with respect to
IVDMIAs.
An IVDMIA, as defined in the draft
guidance document, is a device within
the meaning of the Federal Food, Drug,
and Cosmetic Act (the act). Some
IVDMIAs are laboratory-developed tests
(LDTs); laboratory-developed IVDMIAs
are a specific subset of LDTs. While
FDA has stated that ‘‘clinical
laboratories that develop (in-house) tests
E:\FR\FM\26JYN1.SGM
26JYN1
rwilkins on PROD1PC63 with NOTICES
41082
Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
are acting as manufacturers of medical
devices and are subject to FDA
jurisdiction under the Act,’’ 62 FR
62243 to 62249 (November 21, 1997),
the agency has generally exercised
enforcement discretion over most
standard LDTs. However, in the draft
guidance, FDA recognizes that IVDMIAs
include elements that are not among the
primary ingredients of standard LDTs
(e.g., complex, unique, interpretation
functions). IVDMIAs thus do not fall
within the scope of LDTs over which
FDA has generally exercised
enforcement discretion.
IVDMIAs raise significant issues of
safety and effectiveness. These types of
tests are developed based on observed
correlations between multivariate data
and clinical outcome, such that the
clinical validity of the claims is not
transparent to patients, laboratorians,
and clinicians who order these tests.
Additionally, IVDMIAs frequently have
a high risk intended use. FDA is
concerned that patients and healthcare
practitioners are relying upon IVDMIAs
with high risk intended uses to make
critical healthcare decisions without
any independent assurance that the
IVDMIA has been properly clinically
validated, and without any ability to
assess whether the test yields clinically
valid results.
With this revised draft guidance
document, FDA seeks to identify
IVDMIAs as a discrete category of
device, and to clarify that, even when
offered as LDTs, IVDMIAs must meet
pre- and post-market device
requirements under the act and FDA
regulations, including premarket review
requirements in the case of most class
II and III devices.
FDA received and considered
approximately 60 sets of comments on
the initial draft guidance document,
including comments provided at a
public meeting that was held on
February 8, 2007. After taking the
comments into consideration, the FDA
has updated the draft guidance
document to provide clarifications as
needed.
Certain comments on the initial draft
guidance document requested that FDA
undertake notice and comment
rulemaking rather than issue a guidance
document in order to allow sufficient
opportunity for public input. In
response to this concern, FDA extended
the comment period on the draft
guidance document from 90 days to 180
days, March 5, 2007 (71 FR 68822), and
held a public meeting to provide a
forum for presentations and comments
on the draft guidance document. The
meeting was attended by 266 people
representing a cross-section of
VerDate Aug<31>2005
16:36 Jul 25, 2007
Jkt 211001
interested stakeholders including
industry, consumer groups, and the
medical community. FDA has carefully
considered the comments it has
received. Many comments reflect that
stakeholders construed the definition of
IVDMIAs in the initial draft guidance
document to encompass a wider range
of tests than FDA had intended. The
initial draft guidance document has
been revised to clarify the definition of
an IVDMIA and to provide examples of
tests that the agency does and does not
consider to be IVDMIAs. This section of
the draft guidance was modified so that
stakeholders can more easily
understand the nature of tests
designated as IVDMIAs, and
manufacturers can more easily
determine whether their tests are
IVDMIAs. However, the clarifications do
not alter the scope or intent of the
definition of an IVDMIA found in the
initial draft guidance document.
In response to additional comments
received, the revised draft guidance
document now clarifies FDA regulatory
mechanisms in general, such as how
devices are classified and reviewed
based on the risk of the intended use,
how laboratory-developed IVDMIAs
should be labeled, and how
manufacturers can update and improve
cleared or approved devices using
existing mechanisms within the
regulatory framework. These existing
mechanisms enable manufacturers to
bring innovative new tests to the market
and ensure that they can be updated and
improved as new scientific information
becomes available. While this
information is generally available in
existing regulations, guidance
documents, and on the FDA Web site,
the revised draft guidance provides a
summary of this information with a
focus on IVDMIAs in order to assist
those stakeholders who are not familiar
with existing FDA requirements.
In other comments, some stakeholders
expressed concern that requiring FDA
regulatory compliance for IVDMIAs has
the potential to discourage the
development of new tests for rare
diseases. A manufacturer of an IVDMIA
for a disease or condition that affects
small patient populations may find that
research and development costs exceed
market returns. The draft guidance has
been revised to indicate FDA’s intent to
exercise enforcement discretion for
laboratory-developed IVDMIAs that are
intended to diagnose rare diseases (i.e.,
IVDMIAs that meet the definition of
Humanitarian Use Devices under 21
CFR part 814 Subpart H).
Finally, the draft guidance document
clarifies that laboratories that
manufacture IVDMIAs should follow
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
the Medical Device Reporting
requirements for manufacturers, 21 CFR
part 803 for their IVDMIA device(s). As
in the initial draft guidance, the revised
draft guidance indicates that FDA
intends to issue guidance to assist
laboratories that manufacture IVDMIAs
in complying with the Quality System
regulation (QS), 21 CFR part 820. In
response to comments that expressed
concern about coming into compliance
with the QS regulation, the revised draft
guidance indicates that until such a
final guidance is published, FDA
intends to exercise enforcement
discretion with regard to post-market
QS requirement enforcement for
laboratories that manufacture IVDMIAs,
recognizing that some Clinical
Laboratory Improvement Amendments
of 1988 (CLIA’ 88) requirements may
partially fulfill corresponding QS
regulation requirements.
FDA is issuing this revised draft in
order to gather significant new
comments before issuing a final version
of the guidance. Because the agency
believes it has addressed the most
important concerns raised by the
comments it received on the initial
draft, and because it is important to
issue a final guidance to provide clarity
for stakeholders, FDA is providing a
comment period of 30 days following
publication of this document.
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 represents the
agency’s current thinking on IVDMIAs.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘In Vitro
Diagnostic Multivariate Index Assays,’’
you may either send an e-mail request
to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number 1610 to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
E:\FR\FM\26JYN1.SGM
26JYN1
Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturers’ assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the CBER Internet site at https://
www.fda.gov/cber/guidelines.htm or on
the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–3660 Filed 7–23–07; 12:02 pm]
IV. Paperwork Reduction Act of 1995
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Emergency Use Authorization of
Medical Products.’’ The guidance
explains FDA’s policies for authorizing
the use of an unapproved medical
product or an unapproved use of an
approved medical product during a
declared emergency. This guidance
finalizes the draft guidance published in
the Federal Register of July 5, 2005 (70
FR 38689).
DATES: Submit written or electronic
comments on agency guidances at any
time.
This draft guidance contains
information collection provisions that
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 draft guidance
document have been approved by OMB
in accordance with the PRA under the
regulations governing premarket
notifications (21 CFR part 807, subpart
E, OMB control number 0910–0120)
premarket approval applications (21
CFR part 814, OMB control number
0910–0231), investigational device
exemptions (21 CFR part 812, OMB
control number 0910–0078), quality
system regulation (21 CFR part 820,
OMB control number 0910–0073), and
medical device reporting (21 CFR part
803, OMB control number 0910–0437).
The labeling provisions addressed in
this guidance have been approved by
OMB under OMB control number 0910–
0485.
rwilkins on PROD1PC63 with NOTICES
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document on
or before August 27, 2007. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
comments, except that individuals may
submit one copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Comments received may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Aug<31>2005
17:41 Jul 25, 2007
Jkt 211001
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0333]
Guidance; Emergency Use
Authorization of Medical Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Submit written requests for
single copies of this guidance to the
Office of Counterterrorism Policy and
Planning (HF–29), Food and Drug
Administration, 5600 Fishers Lane, rm.
14C–26, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–827–5671.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance document.
FOR FURTHER INFORMATION CONTACT:
Charlotte Christin, Office of
Counterterrorism Policy and Planning
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
a guidance for industry, government
agencies, and FDA staff entitled
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
41083
‘‘Emergency Use Authorization of
Medical Products.’’ This guidance
describes the agency’s general
recommendations and procedures for
issuance of emergency use
authorizations (EUA) under section 564
of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360bbb–3),
which was amended by the Project
BioShield Act of 2004 (Public Law 108–
276).
Section 564 of the act provides for
authorization of ‘‘emergency use’’ of a
medical product, after a declaration of
emergency justifying an authorization is
issued by the Secretary of Health and
Human Services (the Secretary) based
on one of the following grounds: A
determination by the Secretary of
Homeland Security that there is an
actual or potential ‘‘domestic
emergency;’’ a determination by the
Secretary of Defense that there is an
actual or potential ‘‘military
emergency;’’ or a determination by the
Secretary that there is a public health
emergency under section 319 of the
Public Health Service Act that affects or
has the significant potential to affect
national security. The Commissioner of
Food and Drugs may issue an EUA for
an unapproved drug, device, or biologic,
or an unapproved use of an approved
drug, device, or biologic, during a
declared emergency if the statutory
criteria set forth in section 564 of the act
are met.
On July 5, 2005, FDA published for
comment in the Federal Register a draft
of this guidance. Comments received
from industry, associations, health care
professionals, consumers, and staff of
other Federal agencies have been taken
into consideration in finalizing this
guidance. Changes are based on a
thorough review of all comments
received. As revised, the guidance
includes a more detailed discussion of
the scope of preemption (where
applicable) and also provides points of
contact for further information on
several Federal liability protection and
compensation programs.
This guidance document is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). It represents the agency’s
current thinking on emergency use
authorizations of medical products. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 72, Number 143 (Thursday, July 26, 2007)]
[Notices]
[Pages 41081-41083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3660]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0347]
Draft Guidance for Industry and Food and Drug Administration
Staff; In Vitro Diagnostic Multivariate Index Assays; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance entitled ``In Vitro Diagnostic
Multivariate Index Assays.'' FDA is issuing this revised draft guidance
to address the definition and regulatory status of a class of In Vitro
Diagnostic Devices referred to as In Vitro Diagnostic Multivariate
Index Assays (IVDMIAs). The revised draft guidance also addresses
premarket and postmarket requirements with respect to IVDMIAs. The
initial draft of this guidance was issued September 7, 2006.
DATES: Submit written or electronic comments on this draft guidance by
August 27, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``In Vitro Diagnostic Multivariate Index
Assays'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850 or to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the draft guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.fda.gov/dockets/ecomments. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0694.
For further information concerning the guidance as it related to
devices regulated by CBER: Martin Ruta, Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-3518.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 7, 2006 (71 FR 52800). FDA
published a notice of availability of the initial draft guidance to
address the definition and regulatory status of a class of in vitro
diagnostic devices referred to as ``In Vitro Diagnostic Multivariate
Index Assays (IVDMIAs).'' The initial draft guidance also addressed
premarket and postmarket requirements with respect to IVDMIAs.
An IVDMIA, as defined in the draft guidance document, is a device
within the meaning of the Federal Food, Drug, and Cosmetic Act (the
act). Some IVDMIAs are laboratory-developed tests (LDTs); laboratory-
developed IVDMIAs are a specific subset of LDTs. While FDA has stated
that ``clinical laboratories that develop (in-house) tests
[[Page 41082]]
are acting as manufacturers of medical devices and are subject to FDA
jurisdiction under the Act,'' 62 FR 62243 to 62249 (November 21, 1997),
the agency has generally exercised enforcement discretion over most
standard LDTs. However, in the draft guidance, FDA recognizes that
IVDMIAs include elements that are not among the primary ingredients of
standard LDTs (e.g., complex, unique, interpretation functions).
IVDMIAs thus do not fall within the scope of LDTs over which FDA has
generally exercised enforcement discretion.
IVDMIAs raise significant issues of safety and effectiveness. These
types of tests are developed based on observed correlations between
multivariate data and clinical outcome, such that the clinical validity
of the claims is not transparent to patients, laboratorians, and
clinicians who order these tests. Additionally, IVDMIAs frequently have
a high risk intended use. FDA is concerned that patients and healthcare
practitioners are relying upon IVDMIAs with high risk intended uses to
make critical healthcare decisions without any independent assurance
that the IVDMIA has been properly clinically validated, and without any
ability to assess whether the test yields clinically valid results.
With this revised draft guidance document, FDA seeks to identify
IVDMIAs as a discrete category of device, and to clarify that, even
when offered as LDTs, IVDMIAs must meet pre- and post-market device
requirements under the act and FDA regulations, including premarket
review requirements in the case of most class II and III devices.
FDA received and considered approximately 60 sets of comments on
the initial draft guidance document, including comments provided at a
public meeting that was held on February 8, 2007. After taking the
comments into consideration, the FDA has updated the draft guidance
document to provide clarifications as needed.
Certain comments on the initial draft guidance document requested
that FDA undertake notice and comment rulemaking rather than issue a
guidance document in order to allow sufficient opportunity for public
input. In response to this concern, FDA extended the comment period on
the draft guidance document from 90 days to 180 days, March 5, 2007 (71
FR 68822), and held a public meeting to provide a forum for
presentations and comments on the draft guidance document. The meeting
was attended by 266 people representing a cross-section of interested
stakeholders including industry, consumer groups, and the medical
community. FDA has carefully considered the comments it has received.
Many comments reflect that stakeholders construed the definition of
IVDMIAs in the initial draft guidance document to encompass a wider
range of tests than FDA had intended. The initial draft guidance
document has been revised to clarify the definition of an IVDMIA and to
provide examples of tests that the agency does and does not consider to
be IVDMIAs. This section of the draft guidance was modified so that
stakeholders can more easily understand the nature of tests designated
as IVDMIAs, and manufacturers can more easily determine whether their
tests are IVDMIAs. However, the clarifications do not alter the scope
or intent of the definition of an IVDMIA found in the initial draft
guidance document.
In response to additional comments received, the revised draft
guidance document now clarifies FDA regulatory mechanisms in general,
such as how devices are classified and reviewed based on the risk of
the intended use, how laboratory-developed IVDMIAs should be labeled,
and how manufacturers can update and improve cleared or approved
devices using existing mechanisms within the regulatory framework.
These existing mechanisms enable manufacturers to bring innovative new
tests to the market and ensure that they can be updated and improved as
new scientific information becomes available. While this information is
generally available in existing regulations, guidance documents, and on
the FDA Web site, the revised draft guidance provides a summary of this
information with a focus on IVDMIAs in order to assist those
stakeholders who are not familiar with existing FDA requirements.
In other comments, some stakeholders expressed concern that
requiring FDA regulatory compliance for IVDMIAs has the potential to
discourage the development of new tests for rare diseases. A
manufacturer of an IVDMIA for a disease or condition that affects small
patient populations may find that research and development costs exceed
market returns. The draft guidance has been revised to indicate FDA's
intent to exercise enforcement discretion for laboratory-developed
IVDMIAs that are intended to diagnose rare diseases (i.e., IVDMIAs that
meet the definition of Humanitarian Use Devices under 21 CFR part 814
Subpart H).
Finally, the draft guidance document clarifies that laboratories
that manufacture IVDMIAs should follow the Medical Device Reporting
requirements for manufacturers, 21 CFR part 803 for their IVDMIA
device(s). As in the initial draft guidance, the revised draft guidance
indicates that FDA intends to issue guidance to assist laboratories
that manufacture IVDMIAs in complying with the Quality System
regulation (QS), 21 CFR part 820. In response to comments that
expressed concern about coming into compliance with the QS regulation,
the revised draft guidance indicates that until such a final guidance
is published, FDA intends to exercise enforcement discretion with
regard to post-market QS requirement enforcement for laboratories that
manufacture IVDMIAs, recognizing that some Clinical Laboratory
Improvement Amendments of 1988 (CLIA' 88) requirements may partially
fulfill corresponding QS regulation requirements.
FDA is issuing this revised draft in order to gather significant
new comments before issuing a final version of the guidance. Because
the agency believes it has addressed the most important concerns raised
by the comments it received on the initial draft, and because it is
important to issue a final guidance to provide clarity for
stakeholders, FDA is providing a comment period of 30 days following
publication of this document.
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
represents the agency's current thinking on IVDMIAs. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``In Vitro Diagnostic Multivariate
Index Assays,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1610 to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
[[Page 41083]]
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the CBER Internet site at https://www.fda.gov/cber/
guidelines.htm or on the Division of Dockets Management Internet site
at https://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
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 draft guidance document have been
approved by OMB in accordance with the PRA under the regulations
governing premarket notifications (21 CFR part 807, subpart E, OMB
control number 0910-0120) premarket approval applications (21 CFR part
814, OMB control number 0910-0231), investigational device exemptions
(21 CFR part 812, OMB control number 0910-0078), quality system
regulation (21 CFR part 820, OMB control number 0910-0073), and medical
device reporting (21 CFR part 803, OMB control number 0910-0437). The
labeling provisions addressed in this guidance have been approved by
OMB under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this document
on or before August 27, 2007. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed
comments, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments received may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-3660 Filed 7-23-07; 12:02 pm]
BILLING CODE 4160-01-S
