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15 Abraham, GE and Grewal, H

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Some analysts and industry observers expect that an FDA decision may not occur until late 2026 or 2027, assuming all safety and efficacy endpoints are met

Change history : 2023-10-24: Reference to a new article on Predicate Device and Substantial Equivalence added 2023-09-14: Chapter 2 revised (eSTAR format), latest information added to chapter 4 on modernization of 510(k) procedure

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