"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 plants) those companies are free to do so. Of course, non-medical manufacturers have massive logistical challenges and it may still take months for them to actually be in a position to make ventilators. The FDA's temporary "discretion" will only remove some bureaucratic barriers.
The FDA is also temporarily easing up on regulations about where ventilators can be used, allowing ventilators that are authorized for use in one environment to be used in others. For example, a ventilator that is approved only for home use may now also be used in a health care facility. Devices used to help people with sleep apnea may now be legally modified to help people with COVID-19-related respiratory problems."
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 plants) those companies are free to do so. Of course, non-medical manufacturers have massive logistical challenges and it may still take months for them to actually be in a position to make ventilators. The FDA's temporary "discretion" will only remove some bureaucratic barriers.
The FDA is also temporarily easing up on regulations about where ventilators can be used, allowing ventilators that are authorized for use in one environment to be used in others. For example, a ventilator that is approved only for home use may now also be used in a health care facility. Devices used to help people with sleep apnea may now be legally modified to help people with COVID-19-related respiratory problems."