FDA finalizes guidance on Breakthrough Medical Device market pathway

FDA finalizes guidance on Breakthrough Medical Device market pathway

Submitted by admin on December 28, 2018 - 1:02pm
Source: 
Emergo
News Tags: 
FDA
breakthrough medical devices
devices
Headline: 
FDA finalizes guidance on Breakthrough Medical Device market pathway
snippet: 
  • US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products.
  • The new program incorporates elements of prior FDA programs including the Expedited Access Pathway (EAP) and Priority Review program.

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