FDA WARNING_LETTER - ReBuilder Medical Technologies, Inc.

This FDA Warning Letter, dated July 16, 2008, was issued to ReBuilder Medical Technologies, Inc., following a review of their website. The FDA found the ReBuilder™ and ReBuilder™ EMS devices were marketed for new intended uses without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The devices were deemed adulterated under section 501(f)(1)(B) for lacking an approved PMA or IDE. They were also misbranded under section 502(o) because a 510(k) notice for significant modifications to intended use was not provided, as required by 21 C.F.R. 807.81(a)(3)(ii). The letter cited numerous promotional claims, such as healing diabetic skin ulcers and treating various neuropathies, which significantly deviated from the devices' cleared uses. Further misbranding violations included inadequate directions for use under section 502(f)(1) and, separately, misbranding under section 502(o) due to the firm's establishment registration not being current for 2008 and the devices not being listed. ReBuilder Medical Technologies, Inc. must promptly cease disseminating promotional materials with new intended uses and provide a written response within fifteen working days, detailing corrective actions and a plan to prevent recurrence. Failure to comply could lead to regulatory actions, including seizure, injunction, and civil money penalties.