By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post FDA offers Pre-RFD program for combination products appeared first on MassDevice.
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