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510(k) Guidance and Substantial Equivalence Discussed in MedTech Intelligence Independent Consultant, Jay Mansour, discussed the movement away from substantial equivalence in favor of performance testing for the 510(k) application process in a recent MedTech Intelligence

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In the not-too-distant future, the UK may even offer e-cigarettes to those who wish to quit smoking, as long as the products pass the necessary regulatory hurdles

the tobacco character emerges more prominently