FDA Relaxes Rules...
FDA Relaxes Rules
To Allow for More Ventilators, Finally
Restrictions have been loosened to help ramp up production.
Biomedical equipment specialist Dean Edwards conducts depot-level maintenance on a ventilator at Tobyhanna Army Depot, Penn. (U.S. ARMY/UPI/Newscom)
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.
These are all welcome actions but they should have happened much sooner. There was ample warning that COVID-19 was coming to America. New York City, which has become a massive viral epicenter, is now worried about running out of sufficient ventilators.
Today, New York Gov. Andrew Cuomo (D) complained that the White House hasn't used the Defense Production Act to mandate the manufacture of new ventilators.
But the Defense Production Act isn't a silver bullet. It could take months for new supply lines to develop (though I do have some faith that rapid innovation could occur). Executive fiat can only do so much.
Cuomo should be demanding to know why it took so long for the FDA to get out of the way.
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