FDA sends warning to BMC Medical for allegedly adulterating, misbranding device

WASHINGTON – The U.S. Food and Drug Administration (FDA) issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices, which are imported into the United States by React Health (formerly 3B Medical). Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review. The newly branded G3X APAP, the FDA said, includes new software algorithms that can distinguish between central and obstructive hypopnea events and modifications to its sound-abatement system, gas pathway components, printed circuit board assembly and control software. The agency said these changes could significantly affect the device’s safety and effectiveness, requiring a new regulatory submission before commercialization. As a result, the FDA deemed the devices both “adulterated” and “misbranded” under the Federal Food, Drug, and Cosmetic Act. The warning letter also alleges that BMC failed to report a device correction to the FDA. The agency said certain Luna G3 APAP devices running firmware version G3-2.00.76 could unexpectedly shut down during use, interrupting therapy for patients with obstructive sleep apnea. BMC reportedly addressed the issue by updating the firmware to version G3-2.00.77 but did not submit the required Report of Correction or Removal within the required timeframe. The FDA instructed BMC to respond within 15 business days, outlining corrective actions and plans to prevent future violations. The agency warned that failure to address the issues could lead to further regulatory action and noted that the cited violations may indicate broader quality management and compliance concern.

• When reached for comment, Bill Shoop, CEO of React Health, stated: “React Health and BMC take this matter seriously and are actively engaged with the FDA to address their observations fully and promptly. Our commitment to patient safety, quality and compliance is unwavering, and we continue to serve our customers.”