Software that may be excluded from FDA Oversight



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:

The bill:
(broken link removed)

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!


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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