The last few years have seen the rise of Quantified Self movement and increasing demand for solutions for the Home Health market as the US population continues to age. Many startups are also offering new and very popular personal fitness applications. As a result we are seeing a lot of new products aimed at the personal health and fitness market as well as the medical device market proper. Some entrepreneurs who think they are building a personal fitness device are in fact building a medical device.
Walt Maclay, president of Voler Systems, wrote “Are You Making a Medical Device?” to some practical guidance on how to determine if you are risk for regulatory review and oversight, or substantially more review and oversight than a consumer oriented personal health device would face. Here is an excerpt but you should read the entire article if you are working on a personal health and fitness application or appliance to make sure it’s not really a medical device:
There are lot of exciting and innovative advances in the fitness and healthcare space today. Startups and established firms have introduced thousands of new software and hardware solutions–and more are being developed every day. But some of these companies may think they are making a fitness or home health device when they are actually introducing 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. To be ready to register with the FDA can take tens or hundreds of thousands of dollars of regulatory work for a simple device. Read more