Simbex’s Post

Name: Simbex on LinkedIn: #digitalhealth #regulatory
Uploaded: 2024-04-10T18:46:00.684Z
Channel: Simbex
Description: Simbex is again proud to serve as the industry expert for Dartmouth College's #DigitalHealth accelerator for the second year in a row, providing our industry expertise on developing digital health products. Check out these insights from Amaris Ajamil, PhD, RAC on #regulatory path options and the exact definition of a medical device from a recent presentation!

Simbex

2,284 followers

6mo

Simbex is again proud to serve as the industry expert for Dartmouth College's #DigitalHealth accelerator for the second year in a row, providing our industry expertise on developing digital health products. Check out these insights from Amaris Ajamil, PhD, RAC on #regulatory path options and the exact definition of a medical device from a recent presentation!

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There are definitely some nuances when we get into like digital health even like on the intended use side. So you know, I I put together this little, this little flow chart. So you have your digital health device and you apply your attendant use statement against the medical device definition. Oh. Yes. And so you you look at the definition and you're like you know definitely not doing any of these like no, no way. So you are not a medical device and that's, that's that's it for you. And then or you look at the definition and you're looking at it like, yes, maybe I'm a medical device. And umm and so then you come to this, this next decision point. So there is a whole section of of digital health that is can be considered a clinical decision support software and we'll get into the what that is in in a little bit. But if if you do meet the criteria for clinical decision support software, the FDA is not considering that an F. Medical device. So you would not be a medical device. Umm. If you are not clinical decision support software, you come to, this next decision point is your intended use for general Wellness use and prevents a low risk to safety. There's a there's a couple more criteria in order to be a Wellness device. But if you do meet that criteria, you are still considered a medical device. But the FDA is exercising enforcement discretion, which means that they're not going to require that you are. That that you meet the the FDA regulations prior to marketing your product, they're kind of like turn a turn a blind eye.

Sarah Bolander MS OTR/L

Occupational therapist working with remote monitoring technologies to enhance access to digital health and promote evidenced based best practice.

6mo

Awesome Amaris Ajamil, PhD, RAC. I'll check it out!

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