Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled for Research Use Only or Investigational Use Only; Draft Compliance Policy Guide; Availability

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

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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