COVID-19 Public Health Emergency – FDA Ventilators

FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency.

The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of devices that facilitate respiration, including ventilators and accessories.

SoftwareCPR Comments on FDA Emergency Guidance for Ventilators

This emergency use ventilator guidance temporarily exempts a wide range of changes to ventilator hardware and software from premarket review.  It also allows use of devices such as CPAP machines outside their labeled intended use and home use devices can be used in hospitals.  Even software changes to implement closed loop algorithms for oxygen titration can be released provided they currently have an IDE. Other software changes to adjust parameters or implant remote monitoring and control (to protect medical staff allowing them be in an isolated areas for monitor and adjustment) need no clearances (even if requiring changes or additions to the software architecture) including implementation of bluetooth or other wireless capability.

Cybersecurity controls are still expected.

Obviously manufacturers should still ensure adequate (for the current public health emergency) validation to ensure safety for critical changes.  While FDA has suspended all routine inspections, we also recommend that manufacturers that use this emergency exemption later plan for actions to deal with an eventual return to normalcy in clearance requirements and return to use within normal intended use.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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