October 5, 2020
EUA and full compliance for medical devices
On Sept. 9, Pamela Gwynn (principle engineer) and Ben Dahlen (engineering manager) led a webinar where they presented information concerning gaps between Emergency Use Authorizations (EUA) and full compliance with published standards in order to assist device manufacturers in maintaining products on the market after the current pandemic is over.
Recently, the US Food and Drug Administration has established temporary authorizations to allow emergency market access pathways through EUAs. This is designed to help maintain reliable supplies of medical devices and equipment needed during the ongoing COVID-19 public health crisis. However, these pathways are subject to removal at the FDA’s discretion.
The webinar specifically covered relevant published Emergency Use Design Guidance and Disclosure Guidance for Ventilator, Resuscitator Systems, and CPAP/BiPAP devices.
Key topics covered were:
- Emergency Use Ventilator (EUV) introduction and guidance documents
- EUV overview – including FDA’s expedited approval process related to COVID-19
- Respiratory standards – including critical care ventilators (ISO 80601-2-12), but there are several others that may be more appropriate depending on the product’s intended use (insufficiency, impairment, home healthcare, emergency medical services and more)
- Requirements comparison – a high-level clause-by-clause comparison of the EUV requirements vs. “full compliance” after the EUV
- Challenges – general and specifically related to:
- Risk Management (RM) Process
- Software/Programmable Electrical Medical System (PEMS)
- Markings and documents
- Test results
After the discussion, there were several questions received related to “when” the US FDA EUV registration might be terminated, transition periods, and “what” specifically will happen. Ultimately this will be up to the FDA to determine but please know, UL is here to help you with all of your testing and certification needs.
If you are interested in viewing the webinar, you may access it below: