June 25, 2020
The US Food and Drug Administration has established emergency market access pathways known as Emergency Use Authorizations (EUA) to help maintain reliable supplies of medical devices and equipment needed during the ongoing COVID-19 public health crisis.
Under FDA’s EUA program, manufacturers have been able to produce and distribute ventilators, in-vitro diagnostic testing kits and personal protective equipment (PPE) without having to undergo standard premarket reviews by the agency. However, FDA may rescind an EUA designation at any time, at which point a manufacturer should be prepared either to withdraw its device fully from the US market or seek full premarket authorization from the regulator.
Although FDA determines EUA designations on a case-by-case basis, general guidelines have emerged regarding the extent to which manufacturers must meet various safety and performance requirements, including those of the IEC 60601 and related series of standards.
EUA guidance: Partial 60601 compliance
To help manufacturers navigate FDA EUA qualification requirements and obtain designation, the Association for the Advancement of Medical Instrumentation (AAMI) has published guidelines focused on bringing ventilators and associated respiratory devices to market in the US during the coronavirus pandemic. These guidelines pertain primarily to IEC 60601 standards for safety and performance of medical electrical equipment, and to what extent devices must comply with these standards to qualify for EUA designation.
- For ventilators, the AAMI guidelines provide supplements to requirements of IEC 60601-1 as well as the ISO 80601-2-80 standard for device safety requirements, and cover both Design and Disclosure components.
- For resuscitator systems, the guidelines provide supplemental performance requirements related to IEC 60601-1, as well as add safety requirements; Design and Disclosure components are covered here, as well.
- For CPAP/BiPAP, additional essential performance requirements for IEC 60601-1 and ISO 80601-2-70 are included, plus changes and additions to safety requirements as well as guidance documents for Design and Disclosure.