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Would it necessarily have to be sold as a regulated medical device if it is not used as such? There are many companies which sell devices which claim to functi

Would it necessarily have to be sold as a regulated medical device if it is not used as such? There are many companies which sell devices which claim to function as fetal heart monitors (most of which do not work) which are sold without regulation. There are also consumer-targeted EEG, EKG and such devices which provide medical information but do not claim to be clinical-grade. I don't know what the law here is, but as long as it was not sold with any diagnostic claims, and did not recommend any invasive use, would it fall under regulated equipment? I do agree however that competition (or lack thereof) will be a determining factor.

HeyLaughingBoy 18y ago
(most of which do not work) That's pretty much the key: if you can make it work in a medically useful fashion then there's a lot more money to be made selling it as an actual regulated Device. As long as you don't make medical claims then it won't be regulated as a Medical Device, but it would still have to follow other Consumer Product Safety regulations. Those are much easier/cheaper to meet. The only EEG/EKG type devices I have ever seen were kits and they didn't provide any medically useful information. Ultrasound imager classification is covered here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=884.2225 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
- randallsquared 18y ago
  if you can make it work in a medically useful fashion then there's a lot more money to be made selling it as an actual regulated Device. I can't see why this would be true. Selling it for $500 now (and $50 in five years, as these things go) seems like it would mean an incredibly larger market than selling it for $7-10K, as you suggest.