Inspections, Compliance, Enforcement, and Criminal Investigations
Biolmagene, Inc. 25-May-05
Department of Health and Human Services
Public Health Service
2098 Gaither Road
May 25, 2005
Mr. Mohan Uttarwar
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(0(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
Steven I. Gutman
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health