FDA Issues New Guidance to Increase Availability of Respiratory Devices
The FDA issued guidance to expand the availability of ventilators as well as other respiratory devices and their accessories during the COVID-19 pandemic. The new guidance:
- Allows enforcement discretion for certain modifications to FDA-cleared devices -- such as adding wireless and/or Bluetooth capabilities for remote monitoring, or adding alternative production sites to allow non-medical device manufacturers to produce ventilator parts – without triggering an FDA premarket review.
- Allows hospitals and healthcare providers to use ventilators intended for other environments, or beyond their shelf life.
- Encourages foreign and domestic manufacturers to pursue emergency use authorization to increase production and distribution of ventilators in the U.S.