Letter to Correlogic Systems, Inc.
July 12, 2004
Via FedEx
Peter J. Levine
President and CEO
Correlogic Systems, Inc.
6701 Democracy Boulevard, Suite 300
Bethesda, MD 20817
Re: OvaCheck™
Dear Mr. Levine:
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has completed
its review of the information provided by Correlogic Systems, Inc. (Correlogic)
in its letter of May 7, 2004, and presentation of March 17, 2004, regarding
the OvaCheck™ test developed by Correlogic "to aid in the detection
and early identification of protein expression patterns associated with ovarian
cancer in a high risk population." (May 7, 2004 letter) (Emphasis
in original.) You contend that FDA should, in the exercise of enforcement discretion,
decline to regulate OvaCheck because oversight of Correlogic's laboratory operations
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) is sufficient.
For the reasons discussed below, OIVD has determined that the OvaCheck test
is subject to FDA regulation under the device provisions of the Federal Food,
Drug, and Cosmetic Act (the act).
FDA has recognized the skill and expertise of CLIA-regulated high complexity
laboratories to use reagents in test procedures and analyses of their own development,
and has in general not regulated laboratory-developed testing services.1
This determination has been based in part upon the need to manage the agency's
limited review resources2, and the agency is not at this time undertaking
a general departure from this approach. We do not intend to regulate the activities
of Correlogic's reference laboratory (CSIRL) or its laboratory partners, LabCorp
and Quest, in the ongoing provision of the OvaCheck testing service. The software
intended for use in the OvaCheck, however, is subject to FDA regulation.
Correlogic has developed [DELETED] software [DELETED] at Correlogic's main
laboratory facility in Bethesda, Maryland. [DELETED] software [DELETED] two
clinical laboratories that have licenses from Correlogic to offer the test.
[DELETED] Because these articles of software are "intended for use in the
diagnosis of disease," they are "devices" under the act, 21 U.S.C.
321(h)(2).
Under section 513(f)(1) of the act, 21 U.S.C. 360c(f)(1), "[a]ny device
intended for human use which was not introduced or delivered for introduction
into interstate commerce for commercial distribution before the date of enactment
of this section is classified into class III" unless it has been found
substantially equivalent to a class I or class II device, or unless it has been
reclassified into class I or class II. Correlogic does not contend, and we are
unaware of any evidence, that the software was introduced into interstate commerce
for commercial distribution before May 28, 1976. Our records also do not indicate
that you have obtained either a determination of substantial equivalence to
a class I or class II device or a reclassification for the software.
Under section 515 of the act, 21 U.S.C. 360e(f)(1), a device which is classified
into class III by operation of section 513(f)(1) "is required to have,
unless exempt under section 520(g), an approval under this section of an application
for premarket approval." Your submissions also do not contend, and we confirm,
that you have not sought or received an exemption for investigational use of
the software under section 520(g) or a premarket approval under section 515.
In sum, your [DELETED] software are devices for which premarket approval is
required to establish safety and effectiveness. The appropriate vehicle for
such approval is the submission and FDA review of a premarket approval application
(PMA). PMA requirements are set forth in FDA's regulations (21 C.F.R. part 814).
Additional information on PMAs and on device regulation generally appears at
www.fda.gov. We invite you to discuss with us specific approaches for clinical
investigation of the device or for preparing a submission for FDA review. We
will also be happy to discuss other regulatory requirements that may apply to
your devices.
We remain committed to working with you as we strive to protect the public
health without unnecessarily imposing regulatory burdens on the marketing of
products of potential clinical importance. If you have questions, please contact
Steven Gutman, M.D., at 301-594-3084.
Sincerely yours,
/s/
Steven I. Gutman, M.D., MBA
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health
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