FDA Releases Draft Guidance on Wireless Medical Devices
January 10th, 2007 | Published in Healthcare IT, Patient Flow, Standards & Regulatory | 1 Comment
The FDA has finally released their guidance document (updated link) on medical devices incorporating wireless technologies. We have 90 days from the date of publication (January3, 2007) to submit comments and suggestions.
Once I’ve had a chance to read the whole thing, I will post more.
UPDATE: When I went to leave a comment finding the right page was not easy - so here’s the link.
1 comment so far ↓
[…] year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices. (I can’t […]
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