Startups Push The Limits Of MedTech, But Must Check FDA Compliance
The Startup Magazine
JANUARY 8, 2019
In particular, this past October the FDA announced a significant number of guidance documents to be expected in 2019 , including “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria,” “Breakthrough Devices Program,” and “Humanitarian Device Exemption (HDE) Program.”
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