Brian Dolan writes a story for Mobihealthnews on the FDA’s denial of an IPhone application. (Mobihealthnews Story) The FDA’s definition of medical device is quite broad and there has been limited guidance on how it will apply that definition to emerging communication, data collection, data analysis and data sharing products. Software can be a medical device and any of the various telemedicine, telehealth, ehealth, mhealth, etc. products involves software. The FDA has an emerging awareness of the issue and has had meetings with industry representatives to discuss a rational way to provide useful guidance and a clear regulatory approval process.
Right now, however, there is a lot of uncertainty and probably not a few companies in violation of the need to do some form of filing with the FDA. The story of the company referenced in Mr. Dolan’s article is illustrative of both the uncertainty and the minefields that may await companies interacting with the FDA. MlMvista developed an imaging application for the IPhone, which was briefly available before the FDA advised them that it could not be on the app store. The company had initially tried the 510(k) route for marketing, which allows reference to similar devices already approved and on the market. The theory is that if those devices were safe and effective, the one currently being filed for will also be safe and effective. After going through two 510(k) submissions, the FDA told the company that the device was not substantially equivalent and therefore would be treated as a class III device needing pre-market approval. PMA is a much more rigorous, time-consuming and expensive process.
MlMvista deserves credit for attempting to work with the FDA. It appears that many telehealth and mhealth companies have simply chosen to ignore the potential regulatory complexities. We can anticipate that at some point the FDA will begin an enforcement program. That day will be accelerated if there continue to be stories of adverse medical events related to use of these technologies. FDA needs to clarify its regulatory position and process and should facilitate innovation in health care. And for the sake of the industry, product companies need to respect the regulations and process now in place, however burdensome, so that negative publicity does not drag down the entire segment.