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US Food and Drug Administration

US, Canadian regulators warn of potential medical device shortages following Sterigenics shutdown

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The shutdown of a Sterigenics medical device sterilization facility in the midwestern US may disrupt supplies of hundreds of devices, according to US FDA and Health Canada.
  • US and Canadian regulators have issues recommendations for manufacturers seeking alternative sterilization sites for their devices.
  • Changing sterilization facility sites may affect manufacturers’ current FDA and/or Health Canada registrations.