Software that may be excluded from FDA Oversight

E

esalsan

#1
Dear covers,

Those of you involved with or simply interested in standalone medical device software may find this news relevant.

The US has issued a Bill to amend the Federal Food, Drug & Cosmetic Act to exclude certain software from the definition of devices.

Original source for the news:
http://www.reuters.com/article/2014/11/25/us-fda-technology-idUSKCN0J903C20141125

The bill:
http://ehrintelligence.com/wp-content/uploads/Hatch-Bennet-Health-IT-Draft.pdf

My question: does anyone know what the process for approval of this type of Bills is? Any guess on timescales (e.g. in the order of months/years)?

Thank you!
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
This is just a discussion-draft for a bill. Not filed yet, apparently has only two Senators who would be sponsors if filed, no indication of a significant lobbying/money campaign to make it happen. Also no mention of parallel interest on the House side.

There's no way to project a timeline for something as indefinite and pre-starting-point as this.
 
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