On April 24, 2020, Philips announced that its Emergency Care and Resuscitation (ECR) business may resume manufacturing and shipping of external defibrillators for the U.S., following notification from the U.S. Food and Drug Administration (FDA) that the injunction prohibiting those activities has been lifted.
This business has been operating under a consent decree with the FDA since November 2017. Under the terms of the consent decree, Philips was required to suspend manufacture and distribution of its defibrillators from specific Philips facilities in the U.S., pending FDA certification via inspection of the facilities’ compliance with Quality System Regulation.
However, in order to ensure uninterrupted availability of these life-saving devices in the U.S., the consent decree included exemptions for specific Philips Automated External Defibrillator (AED) models to continue to be manufactured and shipped, in addition to providing necessary device servicing, accessories and consumables.
Philips continues to comply with the terms of the consent decree, which remains in effect, and includes ongoing regulatory compliance monitoring and facility inspections of the ECR business and of Philips’ other patient care businesses by the FDA.