[Federal Register: September 7, 2006 (Volume 71, Number 173)]
[Notices]
[Page 52800-52801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se06-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0347]
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff
on In Vitro Diagnostic Multivariate Index Assays; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic
Multivariate Index Assays.'' This draft guidance addresses the
definition and regulatory status of a class of in vitro diagnostic
devices referred to as In Vitro Diagnostic Multivariate Index Assays
(IVDMIAs). The guidance also addresses premarket and postmarket
requirements with respect to IVDMIAs. An IVDMIA employs data, derived
in part from one or more in vitro assays, and an algorithm that
usually, but not necessarily, runs on software, to generate a result
that diagnoses a disease or condition or is used in the cure,
mitigation, treatment, or prevention of disease.
DATES: Submit written or electronic comments on this draft guidance by
December 6, 2006.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry, Clinical
Laboratories, and FDA Staff on 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. 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 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Submit written comments concerning this draft guidance to the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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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, 240-276-0490, ext. 162.
SUPPLEMENTARY INFORMATION:
I. Background
The definition of a device is set forth at section 201(h) of the
Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 321(h)). It
provides in relevant part: ``The term `device' * * * means an
instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part, or accessory, which is * * * (2) intended for use in
the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other
animals * * *'' (21 U.S.C. 321(h)). An IVDMIA is a test system that
employs data, derived in part from one or more in vitro assays, and an
algorithm that usually, but not necessarily, runs on software, to
generate a result that diagnoses a disease or condition or is used in
the cure, mitigation, treatment, or prevention of disease. An IVDMIA is
[[Page 52801]]
therefore a device within the meaning of the act.
FDA is aware of some confusion about the regulation of IVDMIAs that
are developed by and used in a laboratory. We believe this confusion
derives in part from FDA's approach to regulation of laboratory-
developed tests that use commercially available ASRs and other
commercially available, FDA-regulated components. FDA seeks to dispel
the existing confusion and clarify its approach to regulation of
IVDMIAs with this guidance document.
Some of the apparent confusion is associated with the rules that
classify and regulate analyte specific reagents (ASRs) that move in
commerce (hereinafter ASR rule) (Sec. Sec. 864.4020, 809.10(e), and
809.30 (21 CFR parts 864 and 809)). The ASR rule does not extend to
tests developed in-house by clinical laboratories using commercially
available ASRs and used exclusively by that laboratory, or ASRs created
in-house and used exclusively by that laboratory for in-house testing.
(November 21, 1997 Federal Register, 62 FR 62243, 62249.) While FDA
stated in the preamble to the final ASR rule that ``clinical
laboratories that develop [in-house] tests are acting as manufacturers
of medical devices and are subject to FDA jurisdiction under the act,''
62 FR 62249, FDA chose not to extend the rule to such tests and it has
generally exercised enforcement discretion over laboratory-developed
ASRs and laboratory-developed tests that use commercially available and
laboratory-developed ASRs.
FDA took this approach because it believed it was regulating ``the
primary ingredients of most in-house developed tests,'' and because it
believed that laboratories certified as high complexity under the
Clinical Laboratory Improvement Amendments, 42 U.S.C. 263a, ``have
demonstrated expertise and ability to use ASRs in test procedures and
analyses.'' (62 FR 62249 (emphasis added)).
FDA believed it was regulating the primary ingredients of most in-
house tests because it was regulating the common elements of in-house
tests, including most ASRs (Sec. 864.4020), general purpose reagents
(Sec. 864.4010), general purpose laboratory equipment (21 CFR
862.2050), other laboratory instrumentation (21 CFR part 864, subpart
D), and controls (21 CFR 862.1660). IVDMIAs include elements, as
described in the section on ``Definition and Regulatory Status of
IVDMIAs'' of this guidance, that are not among these primary
ingredients of in-house tests and that, therefore, raise safety and
effectiveness concerns.
Also, as stated previously, FDA decided to exclude laboratory-
developed tests from the ASR rule due to its confidence in high-
complexity laboratories' ability to use ASRs. The manufacture of an
IVDMIA involves steps that are not synonymous with the use of ASRs and
that are not within the ordinary ``expertise and ability'' of
laboratories that FDA referred to when it issued the ASR rule.
Therefore, IVDMIAs do not fall within the scope of laboratory-developed
tests over which FDA has generally exercised enforcement discretion.
FDA intends to issue guidance regarding those laboratory-developed
tests over which it has in the past generally exercised, and over which
it intends to continue to exercise, enforcement discretion. IVDMIAs
must meet pre- and post-market device requirements under the act and
FDA regulations, including premarket review requirements in the case of
class II and III devices.
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 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 ``Draft Guidance for Industry,
Clinical Laboratories, and FDA Staff on 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
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
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 807.87 have been approved under
OMB control number 0910-0120; the collections of information in
Sec. Sec. 809.10 and 809.30 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR 814.20 have
been approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 820
have been approved under OMB control number 0910-0073; and the
collections of information in 21 CFR part 803 have been approved under
OMB control number 0910-0437.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. 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 brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7499 Filed 9-5-06; 4:00 pm]
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