FDA WARNING_LETTER - NeuroMed Devices, Inc.

The FDA issued a Warning Letter to NeuroMed Devices, Inc. after discovering the firm was marketing its ViraCalm and OraCalm products, which are devices, for unapproved indications. While the devices were cleared under 510(k) as Neuro Calm TENS Devices for symptomatic pain relief (prescription use only), a review of the firm's website on August 31, 2012, revealed claims for treating or overcoming herpes. This promotion represents a major change in intended use, potentially affecting device safety and effectiveness. Consequently, the ViraCalm and OraCalm devices are deemed adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE) for these new uses. Additionally, the devices are misbranded under 21 U.S.C. § 352(o) because the firm failed to notify the FDA of its intent to introduce the devices for the new intended use, as required by 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(ii). The FDA noted that the firm had previously agreed to remove herpes references during the original 510(k) review. NeuroMed Devices, Inc. must immediately cease making similar claims and provide a written response within fifteen business days detailing corrective actions, including documentation and a timetable, to prevent recurrence. Failure to comply may result in regulatory actions such as seizure, injunction, or civil money penalties.