FDA Issues New Guidance to Increase Availability of Respiratory Devices

2020-03-23 |

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.