FDA Releases Draft Guidance on Wireless Medical Devices

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.

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  1. Medical Device Interoperability Workshop :: Medical Connectivity - [...] year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on ...

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