A Medical Device Daily
The FDA has sent a letter to Mohan Uttarwar, president of BioImagene (San Jose, California), requiring the company to correct a variety of what it terms “violations” of agency law in statements posted on its web site. The agency in its letter charges that the company is marketing its Pathiam product in such a way that it requires, but does not have, clearance or approval of the agency.
The agency says that Pathiam is, under the Federal Food, Drug and Cosmetic Act, a device “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.” Under these terms, it requires FDA okay for commercialization.
The agency said that, according to the web site, Pathiam is “a hardware-independent, web-enabled software allowing pathologists to view and analyze immunohistochemically-stained slides from any computer via the Internet.” And the agency notes that the company’s web site is promoting the product with “medical and diagnostic claims,” requiring FDA review and approval.
The claims for Pathiam include its use as “an image analysis, quantification, management and retrieval system that assists pathologists in detection, counting, classification and evaluation of cells and tissues . . . 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 “Frequently Asked Questions” area of the site also notes 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.” The letter said that these were not the only deficiencies in the promotional statements.
The agency said that, because of these claims – and lack of clearance – the Pathiam “is adulterated” and “misbranded.” And that failure to correct the violations would result in further agency actions that may include “seizure, injunction, and/or civil money penalties.”
The company was given 15 days in which to inform the agency of the specific steps is taking to correct the noted 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.”