Some easier ways to look at these terms (obviously its much deeper but this is a short version)
InVivo has applied for HUD approval and FDA has 45 days to respond and if they request any additional information this resets the 45 days and the company might need trial info or other info that could take time to gather and re-submit.
HUD- Company needs to show the product is needed for a population of 4,000 or less FDA will approve, Reject or ask for more information inside of 45 days of the HUD submission.
IDE- This gives the company permission to start a Human Clinical Trial
HDE- This gives the company an approval of the clinical trial.
For and HDE and only and HDE the company only needs to prove the product is SAFE its does NOT need to prove efficacy. All other submissions IND NDA PMA etc.. need to prove efficacy.. HDE does NOT.
You could start an IDE clinical Trial before you get HUD or even submit for and HUD. InVivo has gone for the HUD first based on guidance from FDA in 2012.
Hope this helps. Looking for HUD approval soon! 56 products have been HDE approved since 2006 and getting HUD / HDE approval will move NVIV very fast!
It appears like HUD is the lowest hurdle. However, NVIV cannot get HUD in a timely manner (filed on Dec 14 and meet with the FDA in 2012 regarding a HUD designation). Does not bode well for starting clinical trials anytime soon.
I agree on the surface but the facts are they submitted the IDE and then had such great potential then went from one location to the new state of the art facility they have and they can now produce the scaffold in-house. Clean room in-house etc.. this delay is only because they moved to a bigger newer facility. I have zero patience but this only makes sense to give it some time and this will take off fast.. they have a lot of people watching and this is a visual device that lets people see the results.