Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, ...
Three Democratic senators are requesting additional information about the FDA's Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. One of the big take aways from ...
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