FDA Issues Enforcement Policy for Ventilators Amid Shortage Concerns

Ventilator shortages dominated the coronavirus-related news cycle over the weekend with Elon Musk revealing ventilator discussions with Medtronic, and FDA implementing an enforcement policy for ventilators and accessories, along with other respiratory devices. The policy went into effect immediately and will remain in effect for the duration of the coronavirus (COVID-19) public health emergency. "Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate," the agency noted. That said, anyone can submit online or written comments on any guidance at any time. FDA said the policy is intended to foster the continued availability of certain safe and effective medical devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines, and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency. FDA recommendations include: FDA wants hospitals and providers to, whenever possible, use FDA-cleared conventional/standard full-featured ventilators when available to support patients with respiratory failure. Under the policy, manufacturers may make certain modifications to FDA-cleared indications, claims, or functionality of these devices without prior submission of a premarket notification, as long as the modifica...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news