FDA Proposes Rule Recommending Pacemaker be Reclassified- Good Idea! Can’t Have Too Many Debuggers on the Software
Posted Aug 04 2011 2:44pm
This is good as so many medical devices use software today and ensuring safety along with a thorough check of the software is a grand idea. I never minded anyone else debugging anything I wrote and was happy to have another programmer look at it, it’s how it works today. Technology is great but nobody and I mean nobody is 100% as when you think about it, why do we have Windows updates, Mac Updates and Linux updates? It’s a constant process and granted device software is complex and doesn’t have the huge areas of an operating system to verify but the more experienced programmers and/or engineers you have look at it, the better off we all are.
You have to stop and think how fast this market is moving and for years many devices didn’t have software, but today they do. Get the FDA the budget and engineers they need to make it work. They know their business better than any lawmaker, so let them function and get some digital literacy with Congress to realize that laws can’t fix what the FDA needs all the time. The software runs the electrical portions of the devices. BD
Following last week's draft guidance recommending that pacemakers be reclassified as Class III devices that require premarket approval for FDA review, the watchdog agency released a new proposed rule today that would put the external devices used to alter a pacemaker's electrical operating performance in the same category.
Pacemaker programmers non-invasively communicate with the implanted device to modify the rate of pacing or other operating characteristics.