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State-by-State Sterilizer Rules Worry Medical Device Makers

Sept. 23, 2019, 6:52 PM

States setting patchwork standards—instead of uniform federal rules—for a dangerous medical device sterilizer will mean compliance confusion for device makers, an industry trade group said.

“Imagine if you had products in manufacturing facilities in 20 states with 20 different sets of regulation. You would have to outfit every facility differently and make different adjustments for every facility,” Scott Whitaker, president and CEO of the Advanced Medical Technology Association, told Bloomberg Law Sept. 23 during the group’s conference in Boston.

“That’s why we would like the EPA to set a federal standard that we can all understand and live by. There’s...

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