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Miguel joined the group
indieFeed 7 weeks agoHolly3 CommentsView more comments-
Welcome to the indie community, Miguel!
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Welcome to the indie community, Miguel!
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Rebecca joined the group
indieFeed 7 weeks ago-
Hi Rebecca, so happy to have you part of the community!
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NR joined the group
indieFeed 8 weeks ago-
Welcome, NR! EVERYONE go check out NR’s compliance tool in the Library!!
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Holly posted an update in the group
indieFeed 8 weeks agoHi everyone! FutureReady: MedTech Live is back with Episode 04: QMSR – The Eleventh Hour. Join us, along with an esteemed panel, on Thursday, January 29 at 4 pm EST to discuss everything QMSR and what you can do now to be (more) ready on February 2.
Register here: …
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alex joined the group
indieFeed 8 weeks ago-
Welcome to the indie community, Alex!
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Welcome to the indie community, Alex!
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Steve joined the group
indieFeed 8 weeks ago-
So happy to see you here, Steve!
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Thank you, Holly. Excited to be a member and look forward to networking and future collaboration.
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Holly replied to the discussion New FDA Guidance Documents in the forum IndieMedTech 2 months ago
Reply to New FDA Guidance Documents
Thank you! The general consensus seems that its incredibly de-regulating. Normally I think we would all applause at that but it may sway into a potentially dangerous zone. Will be interesting to see how some key players respond next.
For anyone working with wellness or borderline wellness devices, what’s your next step? I have one so now I…
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Allison replied to the discussion New FDA Guidance Documents in the forum IndieMedTech 2 months ago
Reply to New FDA Guidance Documents
There have been some good insights on LinkedIn. One of the issues I have is that they didn’t get public comment! https://www.linkedin.com/posts/mjasonbrooke_general-wellness-policy-for-low-risk-devices-activity-7414359212451102722-9PLY?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAY0NpUBd5pZbxu-B62mmGtViLpjTk8RI30
linkedin.com
The FDA has--without public comment--updated the #ClinicalDecisionSupport Guidance and the #GeneralWellness Guidance. The #FDA appears to have taken a de-regulatory approach, expanding the scope of what falls into the non-device category of products. Below are links to each of the … Continue reading
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Holly posted an update in the group
indieFeed 2 months agoHappy Wednesday! You may have noticed a new tab at the top – the Library! A curated collection of MedTech content created by our members, for our members. We quietly launched this new page and are now ready to celebrate it. Currently, all episodes of FutureReady: MedTech Live can be found there.
Do you have or want to create MedTech content…
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Holly started the discussion New FDA Guidance Documents in the forum IndieMedTech 2 months ago
FDA dropped two new guidance documents today:
- General Wellness: Policy for Low Risk Devices – https://www.fda.gov/media/90652/download
- Clinical Decision Support Software – https://www.fda.gov/media/109618/download
I haven’t had a chance to dig in yet, but has anyone else? Any significant clarifications or advancements that may tangibly help…
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