ARTICLE SUMMARY:
In this week’s Pathways Picks: A potentially eventful week ahead, as the EPA must issue its ethylene oxide emissions rule, with massive potential impacts on device production, and the US Congress has to reach a funding agreement to prevent a government shutdown by this Friday. Also, the UK’s top regulator announces plans to retire, CDRH’s TAP program has a new leader, FDA is pressured on stalled diversity guidance, and European IVDR and data rule updates.
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What we’re watching for:
Ethylene oxide rule by Friday... The US Environmental Protection Agency is expected to issue a final rule regulating ethylene oxide (EtO) emissions from sterilization facilities by March 1 under a deadline set by the courts. Device industry groups warn that if EPA doesn’t make significant changes to last year’s proposed rule to reduce the risk of US facility closures, it will severely impact companies’ ability to maintain needed device supply capacities. “If EPA were to move forward with proposals that would dramatically reduce sterilization capacity here in the US, manufacturers will inevitably have to move some capacity offshore,” Mark Leahey, CEO of the Medical Device Manufacturers Association, told Market Pathways in a recent interview. MDMA, AdvaMed, and other groups have met with EPA and White House officials this month to make a final push for meaningful changes in the final rule. Environmental groups have also been meeting with officials to press for stronger restrictions. In parallel to the emissions regulation, EPA is also working on new rules managing EtO handling within facilities that could add even more challenges to using the chemical, which serves as the sterilization method for about half of all devices produced in the US.
