FDA WARNING_LETTER - Storz Medical, AG

The FDA issued a Warning Letter to Storz Medical Ag after reviewing their website on April 5, 2010, concerning the D-Actor 50 and D-Actor 200 devices. The D-Actor 50 devices were found to be marketed in the U.S. without marketing clearance or approval, rendering them adulterated under section 501(f)(1)(B) of the Act for lacking an approved PMA or IDE, and misbranded under section 502(o) for not submitting a 510(k) notification. For the D-Actor 200 devices, while initially cleared under 510(k) K072809 for minor muscle aches and increased local blood circulation, the firm's website made new claims such as "tissue is purified" and "the interaction between the central and peripheral nervous systems is improved." These statements represent a major change in intended use, requiring a new premarket notification per 21 CFR 807.81(a)(3)(ii). Consequently, the D-Actor 200 devices are also deemed adulterated and misbranded for these unapproved uses. Storz Medical is required to immediately cease marketing both devices for unapproved uses and take prompt corrective action. The firm must respond in writing within fifteen working days, detailing corrective steps, preventative measures, and supporting documentation. Failure to comply may lead to severe regulatory actions, including seizure, injunction, civil money penalties, refusal of device admission into the U.S. via Import Alert, and denial of Certificates to Foreign Governments.