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