Understand the Difference Between a Medical Device and a Fitness Device - and the FDA Risks if You Get it Wrong


There are a lot of exciting and innovative advances in the fitness and healthcare space today. But some companies may think they are making a fitness or home health device when they are actually making a medical device without realizing it.

If you make a medical device and don’t register it with the FDA, you risk getting a letter from the FDA with an injunction and a notice to stop selling your product. 


Download this Whitepaper and learn the ins and outs of making a medical device.

  • Is it a  medical device?
  • FDA updates on mobile apps
  • Mobile medical apps regulated by the FDA
  • Classification of medical devices

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