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» FDA predetermined change control program major shift for med-tech
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FDA predetermined change control program major shift for med-tech
Nov. 21, 2023
By
Mark McCarty
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
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