Why It Takes So Long to Develop a Medical Technology (Part 3)
Written by Mark Carol, MD
Published:
Regulatory Authorization – In this blog, Mark Carol, MD, a senior consultant at the Foundation, gives an overview of the ways medical device companies can approach US FDA approval. FDA regulatory authorization is required to sell a device in the US. There are three main paths toward achieving authorization in the USA: PMA approval, 510(k) clearance, or De Novo grant. Approximately 4,000 510(k) applications are submitted to the FDA each year, compared to less than 100 PMA applications.
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