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New FDA Guidance Documents
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New FDA Guidance Documents
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 manufacturers that can be passed along?
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2 Replies
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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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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 am feeling like we have to rethink all of our latest guidance to them…
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