Court Approves Consent Decree in Philips FDA Case
In a significant development, the court has officially approved a consent decree between Philips and the FDA, stemming from identified issues with certain Philips Respironics sleep and respiratory care devices.
As part of the decree, Philips Respironics must cease production of most sleep and respiratory devices at three Pennsylvania facilities until specific requirements outlined in the agreement are met. This includes a prohibition on selling new CPAP, BiPAP, or other respiratory care devices within the U.S. until compliance is ensured.
The decree also mandates external inspections of Philips’ Sleep and Respiratory Care facilities to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA), particularly regarding the testing of foam used to replace sound abatement foam in recalled devices. The FDA is granted authority to impose injunction provisions on additional facilities if future inspections reveal non-compliance, underscoring the commitment to safety and regulatory standards.
This regulatory action follows heightened scrutiny over the safety and reliability of Philips’ devices, particularly concerning the foam degradation issue. The consent decree aims to comprehensively address these concerns before allowing Philips’ products back into the U.S. market.
