INDiE Med Tech | Allison | Activity https://indiemedtech.com/members/akomiyamabluestocking-health/activity/ Activity feed for Allison. Mon, 11 May 2026 21:48:45 -0400 https://buddypress.org/?v=2.14.0 en-US 30 hourly 2 2fc37a8e429ba552d654c32e8bbda917 Allison joined the group eQMS https://indiemedtech.com/news-feed/p/668/ Wed, 07 Jan 2026 17:44:03 -0500 0 a3407f9bc0be6f2c8c4a00419ff335e7 Allison replied to the discussion New FDA Guidance Documents in the forum IndieMedTech https://indiemedtech.com/groups/indiefeed/forum/topic-discussion/new-fda-guidance-documents/#post-4166 Wed, 07 Jan 2026 17:43:45 -0500 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

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General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff | M. Jason Brooke | 11 comments

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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