FDA WARNING_LETTER - Belmont Instrument Corporation

The FDA issued a Warning Letter to Belmont Instrument Corporation regarding their Belmont Hyperthermia Pump. The firm obtained 510(k) clearance (K090089) for the device to raise the temperature of the thoracic or peritoneal cavity by continuously lavaging with warmed sterile solution.

However, an FDA review of the firm's website on March 26, 2012, revealed the device is being marketed for unapproved uses. A video on belmontinstrument.com showed the pump used for cancer treatment in the appendix and with chemotherapeutic drugs. Additionally, hipecdoctor.com, registered by Belmont Instrument Corporation, presented information on Hyperthermic Intraperitoneal Chemotherapy (HIPEC), describing the device's use with heated chemotherapy for cancer treatment, implying higher, more effective doses without systemic risks.

These unapproved uses render the Belmont Hyperthermia Pump adulterated under section 501(f)(1)(B) of the Act, as the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). The device is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device for these new intended uses, as required by section 510(k) and 21 CFR 807.81(a)(3)(ii).

The FDA requests Belmont Instrument Corporation immediately cease marketing the device for