The U.S. Food and Drug Administration has extended by 6 months the period during which medical device manufacturer Steris may provide technical support for its System 1 liquid chemical sterilization system, including the ongoing sale of sterilant, as customers complete their transition to an alternative processing technology. Steris says it requested the extension on behalf of its customers.
The FDA says the extension applies only to those SS1 customers who have placed orders for products to replace all remaining SS1s in their possession and have provided a properly completed
Certificate of Transition.
Dan O'Connor
