I really would appreciate any input regarding their experience on current (2022) timeframes wherein FDA gives a response to device modifications to cleared devices submitted under the FDA Enforcement Policy for Ventilator during the COVID-19 Pandemic. I understand that the Ventilatory Enforcement Policy is about to be withdrawn, however it is still in effect and we have a cleared ventilator we needed to add humidifier and additional feature and decided to use the Enforcement Policy pathway before submitting a 510(k) which takes a lot longer.
Also, the language in the Enforcement Policy is that the FDA does not intend to object to modifications to cleared ventilators, does that mean we can go ahead and market the product while the FDA is still reviewing our EUA submission?
Thanks,
Bryan Lucero
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John Bryan Lucero
Manchester NH
United States
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