[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