FDA WARNING_LETTER - HOSPIMED

The FDA issued a Warning Letter to QLRAD Netherlands for illegally marketing its RectalPro Endorectal Balloon (ERB) in the United States without required marketing clearance or approval. Based on the firm's website and brochures, the FDA determined the device is adulterated under section 501(f)(1)(B) of the Act due to the absence of an approved premarket approval (PMA) or investigational device exemption (IDE) application. Additionally, the device is misbranded under section 502(o) for being introduced into interstate commerce without submitting a premarket notification (510(k)). Although rectal balloons for prostate immobilization are classified as Class II devices requiring 510(k) clearance, QLRAD's device is not exempt from premarket notification under 21 CFR 876.4730 because its intended use for prostate immobilization during radiation therapy differs from legally marketed devices and raises new safety concerns. Despite prior communications with the FDA and claims of not marketing the product, evidence indicates active commercial distribution. QLRAD must immediately cease commercial distribution of these uncleared devices and provide a written response within fifteen business days detailing corrective actions, including documentation and a timetable for systemic changes. Non-compliance will result in continued refusal of admission for the devices into the U.S.