Breaking Down FDA's Insane Draft Guidance on Choosing a Predicate

Funny? Yes. Nonsensical? Sometimes. Aggravating? Quite often?
But I haven't had reason to label a draft FDA guidance as psychotic - until now.
This is a shining example of why posting your comments to a draft document is SO very important - more to come on that.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501k, medical device regulation, FDA 510(k), FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance

[@Sattva468]

You know it’s gonna be good when it starts with “FDA’s insane draft guidance” 😆