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Yes, but more importantly, medical device makers have broad immunity when their devices go through the PMA process (the most stringent type of FDA approval). Ba
by seehafer 12y ago
Yes, but more importantly, medical device makers have broad immunity when their devices go through the PMA process (the most stringent type of FDA approval). Basically, the argument is "hey, the FDA said it was safe".
- dsuth 12y agoThen this is where the pressure needs to be applied - at the certification process. It needs to be made a legal requirement to attain certification (if not already), and the certifiers need to follow best practices for vulnerability detection. And it needs to be an ongoing, open process.
- niels_olson 12y agoYes, the FDA certification should include something along the lines of "Manufacturer has an ongoing process to evaluate new vulnerabilities and push updates to affected individuals."
- seehafer 12y agoIt does, at least for new approvals post ~2012. Doesn't help existing devices in the field though.