Manufacturers and hospital administrations: Do your devices and their reporting systems fall into the FDA medical device data system (MDDS) regulations that became effective in the US today? If so, you need to register your device by 18 May and to have compliant systems in place by 15 February 2012. If you don’t know, check out the information on the Mobile Health Informaticist blog post: FDA MDDS Rule : What you don’t know can hurt you. Jeff Brandt, who runs the blog, is keeping tabs on the issues. There is an FDA presentation in PDF form (link says ‘link to webinar’) but you will find the actual replay of the 45 minute HIMSS webinar, with decision tree flowchart at 42 mins, more informative. [Warning – examples of presentation design that gets PowerPoint a bad name!]
[Ed. Donna’s addition to Ed. Steve’s post: The MDDS decision tree flowchart from HIMSS is here. Furthermore, there are significant additional points about devices that came under previous regulations emerging in the LinkedIn Connected Health Community Group discussion: Program to Explore FDA and other policy issues associated with mhealth technologies.]
Thanks to both Editors for highlighting this. The flowchart is really useful.
Activity monitors are becoming popular for helping COPD patients meet activity targets. A good case in point as to whether they should be regulated as a Med-Dev or not.
Laura - GrandCare
Thanks so much Donna! Very timely and helpful!!
Thanks! Very helpful.