FDA Relaxes Rules To Allow for More Ventilators, Finally
The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly to respond to the spread of COVID-19.
In new guidance issued on Monday, the FDA said that it will practice “enforcement discretion” by allowing manufacturers of ventilators to allow for some modifications of hardware, software, and materials. This allows manufacturers more flexibility in response to supply shortages that could keep them from ramping up production.
The new guidance will also allow for the quicker addition of new production lines and alternative production locations, meaning that if other companies that have space to install production lines of their own (GM, for example, has offered unused space in its shuttered p
Article from Latest – Reason.com