[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Notices]
[Pages 235-236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-011]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0506]
Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled
for Research Use Only or Investigational Use Only; Draft Compliance
Policy Guide; 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 a draft Compliance Policy Guide (CPG) entitled
``Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled for
Research Use Only or Investigational Use Only.'' The purpose of the CPG
is to provide guidance on FDA's enforcement priorities concerning
investigational or research IVD's that are being commercialized for
diagnostic or prognostic purposes.
DATES: Written comments on the draft CPG may be submitted by April 6,
1998.
ADDRESSES: Submit written comments on the draft CPG to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written requests
for single copies of the draft CPG to the Division of Small
Manufacturers Assistance (DSMA), Center for Devices and Radiological
Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850 (301-443-6597 or outside MD 1-800-638-2041).
Send two self-addressed adhesive labels to assist that office in
processing your requests, or FAX your request to 301-443-8818.
Facsimiles of the draft CPG are available from the Division of Small
Manufacturers Assistance, CDRH. To receive the draft CPG on your fax
machine, call the CDRH Facts-On-Demand system at 1-800-899-0381 or 301-
827-0111 from a touch tone telephone. At the first voice prompt press
``1'' to access DSMA Facts, at the second voice prompt press ``2,'' and
then enter the document number, ``671,'' followed by the pound sign,
``''. Follow the remaining voice prompts to
complete the request. Copies of the draft CPG may also be downloaded to
a personal computer with access to the World Wide Web (www). The Office
of Regulatory Affairs (ORA) and CDRH Home Pages include the draft CPG
and may be accessed at ``http://www.fda.gov/ora'' or ``http://
www.fda.gov/cdrh'' respectively. The draft CPG will be available on the
Compliance References or Compliance Information pages for ORA and CDRH
respectively.
FOR FURTHER INFORMATION CONTACT: Betty W. Collins, Office of Compliance
(HFZ-300), Center for Devices and Radiological Health, Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4588,
ext. 165.
SUPPLEMENTARY INFORMATION: FDA has developed a draft CPG to provide
guidance on FDA's enforcement priorities concerning investigational or
research IVD's that are being commercialized for diagnostic or
prognostic purposes. This draft CPG applies to IVD's sold or
distributed as test kits. Many manufacturers of IVD's have not followed
the requirements set forth in parts 809 and 812 (21 CFR parts 809 and
812). As a result, numerous IVD's labeled for research or
investigational purposes are being promoted, distributed, and used for
commercial purposes. This has resulted in the widespread use of
laboratory tests with unproven performance characteristics. Unless
exempted from the requirement to submit premarket notification under
section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360b(k)), IVD's that are commercially distributed for
diagnostic use prior to FDA approval or clearance are adulterated and
misbranded under sections 501(f)(1)(B) and 502(o) of the act (21 U.S.C.
351(f)(1)(B) and 352(o)). Such distribution subjects the devices and
responsible firms to regulatory action.
However, FDA recognizes that certain improperly commercialized
IVD's have been in extensive clinical use for a significant period of
time. FDA further recognizes that immediate regulatory action against
certain IVD's might result in adverse consequences to individual
patients and the public health. Therefore, FDA has prepared a draft CPG
in order to describe its enforcement policy. Except in specified
instances, FDA does not intend to initiate enforcement action, for 18
to 30 months from the Federal Register publication date of the notice
of availability (NOA) for the final CPG on commercialization of IVD's
labeled for research use only or investigational use only, against
IVD's that have not been approved or cleared, provided the IVD
manufacturers, importers, and distributors take steps and obtain FDA
approval of a premarket approval application, product license
application, or clearance of a premarket notification submission under
section (510(k)) of the act during that time period. Those steps
include undertaking, by 6 months from the Federal Register publication
date of the NOA for the final CPG, any necessary clinical
investigations or other studies under a protocol sufficient to allow
determination of the IVD's safety and effectiveness. FDA believes that
the 18- to 30-month time period is a reasonable period for gathering
safety and effectiveness data and obtaining FDA approval or clearance.
This draft CPG applies to IVD's that are regulated by FDA's CDRH and
Center for Biologics Evaluation and Research, and supersedes FDA's
earlier draft made public in June 1996.
This draft CPG does not cover analyte specific reagents (ASR's)
that, as specified under Secs. 809.10(e), 809.30, and 864.4020 (21 CFR
864.4020), are not labeled or promoted with performance claims, and are
sold to: (1) In vitro diagnostic manufacturers; (2) clinical
laboratories regulated under the Clinical Laboratory Improvement
Amendments of 1988 as qualified to perform high complexity testing
under 42 CFR part 493 or clinical laboratories regulated under the
Veterans Health Administration Directive 1106; and (3) organizations
that use the ASR to make tests for purposes other than providing
diagnostic information to patients and practitioners. ASR's are defined
as
[[Page 236]]
antibodies, both polyclonal and monoclonal, specific receptor proteins,
ligands, nucleic acid sequences, and similar reagents which, through
specific binding or chemical reaction with substances in a specimen,
are intended for use in a diagnostic application for identification and
quantification of an individual chemical substance or ligand in
biological specimens. FDA's final rule on ASR's was published in the
Federal Register of November 21, 1997 (62 FR 62243).
Additionally, this draft CPG does not pertain to in vitro products
whose use is limited to laboratory research that is entirely unrelated
to the development of IVD's.
This draft guidance document represents the agency's current
thinking on commercialization of in vitro diagnostic devices labeled
for research use only or investigational use only. 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, regulations, or
both.
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft CPG entitled
``Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled for
Research Use Only or Investigational Use Only.'' Two copies of any
comments are to be submitted, 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. The agency will review all
comments, but in issuing a final CPG, need not specifically address
every comment. The agency will make changes to the CPG in response to
comments, as appropriate. A copy of the draft CPG and received comments
may be seen in the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
Dated: December 22, 1997.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 98-011 Filed 1-2-98; 8:45 am]
BILLING CODE 4160-01-F