Among January’s unusually aggressive CDRH enforcement actions (previous item) was a four-page Warning Letter from Center compliance director Steven D. Silverman to an Israeli firm, Curatronic Ltd., for marketing pulsed electromagnetic field devices without clearance or approval. The letter took only 21 days to issue during the height of the holidays.
FDA is often cited for being more aggressive with foreign firms than domestic ones because it has the power to block imports. Further, Curatronic’s devices belong to a category that has a long history of promotional abuse and quackery─but Silverman’s speed is still remarkable.
His letter acknowledged Curatronic’s submission of a 510(k) remarket notification for the BioMove 3000 and 5000 devices for use in stroke rehabilitation by muscle reeducation, prevention or retardation of disuse atrophy, and increasing local blood circulation.
However, the letter said, the company’s Web site is promoting the devices for uses for which it does not have clearance and makes claims not covered by the 510(k)s. FDA also determined that the company is marketing four other cited devices without premarket clearance or approval.
The company was told to stop disseminating promotional materials for the BioMove devices that are the same or similar to those described in the Warning Letter and to stop distributing the four other devices until clearance or approval is obtained.
Boilerplate language threatened detention of the devices “without physical examination upon entry into the United States …” and possible alerts to other federal agencies “so that they may take this information into account when considering the award of contracts.”
Back to Main Article
CDRH Roars in January