Firm Cited for Promoting Device for Indications Without Clearance

Eidam Diagnostics was cited by the FDA for marketing its CRT 2000 Thermographic System for numerous indications that have not been cleared by the agency, according to a recent warning letter.

The system is a noninvasive, reproducible thermographic tool that evaluates predetermined skin temperature points. It is able to detect changes in the body’s temperature regulation, producing data that can be used for adjunctive diagnosis of certain conditions, including breast abnormalities, peripheral vascular disease and musculoskeletal disorders, according to the company’s website.

CDRH’s Office of Compliance requested the company “immediately cease the dissemination of promotional materials” that market the product for the indications not cleared in its 510(k) application, according to the warning letter, which was sent July 26 and posted on the agency’s website last month.

Eidam told D&DL that it has responded to the warning letter and immediately ceased promoting the indications cited by the FDA upon receipt of the letter.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6445c.pdf.