To Philips Respironics US VGM Customers:
On April 9, 2024, the consent decree agreed to by Philips Respironics and the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA) went into effect. The consent decree provides a clear path forward for Philips Respironics to take specific actions with defined milestones and deliverables to demonstrate compliance with the relevant FDA regulatory requirements.
Impact of the consent decree in the US
In the US, Philips Respironics will continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply masks and other accessories, consumables and replacement parts. Until agreed with the FDA, Philips Respironics will not resume selling new CPAP or BiPAP sleep therapy devices or other respiratory care devices Our intention is to return to serving healthcare providers and patients in the US with sleep therapy devices once the relevant requirements of the consent decree have been met.
For our VGM customer, please note, that the consent decree does not impact the products you have on consignment to support your business model
Our business outside of the US
Outside the US, Philips Respironics will continue to provide sleep and respiratory care devices, masks and other accessories, consumables, and replacement parts, subject to certain requirements.
Update on remediation efforts
We will continue to prioritize the completion of the Philips Respironics June 2021 recall. More than 99% of the actionable registered CPAP and BiPAP sleep therapy devices have been remediated globally, while the remediation of mechanical ventilators is ongoing in coordination with the relevant competent authorities.
Our strategic focus
Philips remains committed to the Sleep & Respiratory Care business and to meeting the requirements of the consent decree. We will further strengthen our quality system and processes, with a continued emphasis on providing products that patients and caregivers can trust. We acknowledge the challenges of the last few years and are fully committed to restoring the trust of our customers, and continuing to serve the millions of patients who rely on our devices every day.
If you have questions related to the consent decree, please visit Philips com/consentdecree
Thank you for your continued support
Sincerely,
Daniel V Leonard Business Leader Sleep & Respiratory Care Philips Respironics