Letter to BioImagene, Inc.
Via Federal Express
May 25, 2005
Mr. Mohan Uttarwar
President
BioImagene, Inc
1340 South De Anza, Suite 203
San Jose, California 95129
Dear Mr. Uttarwar:
Based on a recent review of your website, http://bioimagene.com,
the Food and Drug Administration (FDA) has concluded that you are
marketing PATHIAM without approval or clearance from FDA, in violation
of the law.
According to your website, PATHIAM is "a hardware-independent,
Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained
(IHC-stained) slides from any computer via the Internet." PATHIAM
is a device as that term is defined in Section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. § 321(h)) ("the
Act") because it is intended for use in the diagnosis of disease
or other conditions, or in the cure, mitigation, treatment, or prevention
of disease, or because it is intended to affect the structure or
any function of the body.
The Act requires that manufacturers of medical devices obtain marketing
approval or clearance for their products from FDA before they may
offer them for sale. This helps protect the public health by ensuring
that new medical devices are shown to be both safe and effective
or substantially equivalent to other devices already legally marketed
in this country.
The Frequently Asked Questions (FAQ) section of your website notes
that “PATHIAM is an intelligent image analysis software system
designed to fulfill the needs of objective analysis of oncopathology
images. It is [an] information driven Histopathological and Cytopathologic
image analysis, quantification, management and retrieval system
that assists pathologists in detection, counting, classification
and evaluation of cells and tissues in the given image, and caters
to the smarter diagnostic practices needed by researches, oncopathologists,
and physicians, in their war against cancer – a step ahead
in pathological diagnosis and prognosis.”
The FAQ section further states that the device is "helpful
in enhanced diagnostics" because it "increases accuracy,
reproducibility and reduces the false negative and positive counts
that are critical in diagnosis and prognosis."
It appears from the above-referenced promotional information, as
well as other information available on your website, that you are
marketing PATHIAM as a device with medical and diagnostic claims.
Accordingly, the PATHIAM is adulterated under section 501(f)(1)(B)
of the Act because you do not have an approved application for premarket
approval (PMA) in effect pursuant to section 515(a) of the Act or
an approved application for an investigational device exemption
(IDE) under section 520(g) of the Act. This device is also misbranded
under section 502(o) of the Act, because you did not notify the
agency of your intent to introduce the device into commercial distribution,
as required by section 510(k) of the Act. For a device requiring
premarket approval, the notification required by section 510(k)
of the Act is deemed satisfied when a PMA is pending before the
agency [21 C.F.R. 807.81(b)]. The kind of information you need to
submit in order to obtain this approval is available through the
Internet at http://www.fda.gov/cdrh/devadvice/3122.html.
The FDA will evaluate this information and decide whether your product
may be legally marketed.
This letter is not intended to be an all-inclusive list of deficiencies
associated with your device. It is your responsibility to ensure
adherence to each requirement of the Act and regulations for every
FDA-regulated product that you market. You are responsible for investigating
and reviewing all materials to ensure compliance with applicable
regulations.
You should take prompt action to correct these violations. Failure
to correct these violations promptly may result in regulatory action
being initiated by the FDA without further notice. These actions
include, but are not limited to, seizure, injunction, and/or civil
money penalties. Also, Federal agencies are informed about the Warning
Letters we issue, such as this one, so that they may consider this
information when awarding government contracts.
Please notify this office in writing within fifteen (15) working
days of receipt of this letter of the specific steps you have taken
to correct the noted violations, including an explanation of each
step being taken to prevent the recurrence of similar violations.
If corrective action cannot be completed within 15 working days,
state the reason for the delay and the time within which the corrections
will be completed.
Please direct your response to James Woods, Deputy Director of Patient
Safety and Product Quality, Office of In Vitro Diagnostic Device
Evaluation and Safety, 2098 Gaither Road, HFZ-440, Rockville, Maryland
20850.
Sincerely yours,
/S/
Steven I. Gutman
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health
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