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.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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Next public offering: February 12-15, 2024

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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