GHTF, next-gen MDD...headed in the same direction?

M

MIREGMGR

#1
We know that the next-generation MDD, 2007/47/EC, will include a clarification (which for many device makers will amount to a change from the prior-assumed meaning) to the effect that all medical devices should include a clinical evaluation in their technical file.

We also know that the FDA is currently asking for comments on the Global Harmonization Task Force (GHTF) Study Group 5's draft document "Clinical Investigations".

Do these two regulatory-evolutionary changes head in the same direction? Will compliance with 2007/47/EC position us to not have to make further changes to comply with future FDA regulations if those regs are modeled on the current GHTF draft?
 
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A

Adele

#4
Who knows? It appears the harmonization is a word that regulators like to use to signify "a goal" but their actions sometimes feel like it is something that they are actively working against!

What about the GAO report that is due looking at the classification of Class II devices? Will the FDA go the route of the EU and have a Class IIa and Class IIb? Will they call it something different? Class ii and Class II? Class 2 alpha and Class 2 beta?
 
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