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RE: FDA: It's a lot worse than pacemakers. Desktop medical image viewing software is also regulated under FDA-510k procedures. Our iPhone viewer has been tie
by yoden 16y ago
RE: FDA:
It's a lot worse than pacemakers. Desktop medical image viewing software is also regulated under FDA-510k procedures. Our iPhone viewer has been tied up in the FDA morass for more than two years now. We're submitting a 510k for our cloud image sharing service, just in case.
Basically, if you market your product with the intent for it to be in any way involved with medical procedures, you fall under the purview of the FDA. Which is much, much harder to deal with than the iso equivalents. To the extent that we, as a small american company, have been launching things first in europe.
- lkrubner 16y agoI had the same experience. A friend developed software for monitoring outcomes with regards to pacemakers. I helped a little bit on this project. This was done for a British company. At the time the software was fairly innovative, treating the patient as the center point of the all of the data, rather than the pacemakers, and able to consolidate and compare all "events" (negative events such as failure of the packmaker). The idea was that eventually the software, and the equipment, would be released in the USA. This never happened. It is in use in the UK, but bringing into the US would require far more of an up front investment than anyone is willing to make. In theory, the FDA exists to keep Americans safe. However, it is possible to look at some of its regulatory moves as aiming at consolidation within the industries that supply drugs and equipment to the medical field. I imagine it is easier to regulate an industry with 10 companies than an industry with 10,000 companies. However, the true cost is that a lot of innovation gets squeezed out.