When developing a product, it’s always a good idea to be on the lookout for laws that might cause problems for your creation. If you started building an apartment complex, you’d like to know in advance that they need to have electricity, right?
When your company decides to build something, it is important to make sure the product has been classified properly. If your new product is intended for use in medical applications, it will need to get the FDA’s approval. The FDA doesn’t regulate medical procedures, just products. Software’s ambiguous nature confuses whether it is a product or not, but since it is code written on a medium, it counts as a physical product.
To paraphrase the FDA’s own words, a medical device is a device intended for use in the diagnosis of disease or other conditions, or used in the cure or treatment of disease in man or other animals, or intended to affect any function of the body.
The FDA may also regulate accessories to medical devices. Dedicated devices used to monitor or control medical equipment are under the FDA’s jurisdiction. There are different levels of regulation depending on the risks associated with the parent product. A controller for an insulin pump would have to meet stricter requirements than a body mass index calculator. Smartphones may house applications and become medical devices, but smartphones have to go through a series of stringent tests already, and the FDA honors many of those tests, but may still do their own.
Applications on smartphones can be placed into three categories: standalone, accessories and components. Standalones do not connect to any other device, accessories are sold to users and connect to standalone devices, and components are sold to manufacturers and are used in the final product. These each have varying requirements for FDA approval. Accessories are regulated to the same degree as the products they connect with, and components are regulated for safety and reliability, as it is the safety and reliability of the end product that is most important.