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      • And more…
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      • Performance evaluation of IVDs
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September 2019


The FDA’s Safer Technologies Program: Faster access to the US market?

By Prof. Dr. Christian JohnerSeptember 24, 2019Leave a comment

With its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations. In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and…

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Abbreviated 510(k) – When the abbreviation is allowed

By Luca SalvatoreSeptember 23, 2019Leave a comment

Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,

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