FDA Clinical Decision Support Software vs. EU's Medical Device Regulation - Food, Drugs, Healthcare, Life Sciences
To print this article, all you need is to be registered or login on Mondaq.com. In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation ("MDR") in the European Union, this post will discuss some of the similarities between FDAs Clinical Decision Support ("CDS") Software Draft Guidance (together the "CDS Draft Guidance") and the MDR. While still in draft form, we note that FDA has signaled its intent to finalize the CDS Dra...
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Source: mondaq.com