Software Companies Jump Through Hoops for FDA Classification
Broadly defined, software as a medical device is any application used by providers to make clinical decisions. An increasing number of applications are now officially designated as FDA-regulated devices. Is it worth it to pursue this classification for your own software?
If your objective is to make it an indispensable tool in the healthcare and life sciences industries, there’s a decided market advantage to entering the regulated medical device arena. What’s more, work you’ve done to date to achieve compliance with another set of controls – the HIPAA Security Rule – can be applied to obtaining the FDA classification.
On that note, be aware that the FDA has three tiers of classification for medical devices, each based on intended use of the application and the risk the application poses to patients or users.
This article is concerned with FDA Class I, the tier reserved for low-risk devices, and therefore, subjected to the least amount of regulation. All Class 1 devices must, however, conform to certain requirements, including annual registration with the FDA, careful product labels and descriptions on both the product and accompanying sales and marketing literature, and other regulations.
The upside of FDA scrutiny
There are a number of reasons – all good ones – why software companies would willingly jump through the necessary hoops to obtain FDA classification.
First, large integrated health networks increasingly need FDA classification for the applications they use to make medical decisions. It makes life a lot easier for them, especially from a legal standpoint, if these apps are cleared for FDA approval.
Healthcare is also entering an unprecedentedly collaborative era, with a proliferation of joint projects concerned with testing new innovations and technologies. The market for a promising new product could be bigger with FDA classification.
There’s also the matter of software taking an ever more important role in healthcare. From analytics to radiation dose monitoring, healthcare today relies on a broad range of applications. For many of these apps, FDA classification is or will become a mandate. Vendors that get ahead of this now will be better positioned than those that have to rush to catch up.
Some may be wondering if this includes consumer-focused apps, such as personal health tracking and coaching products. As it happens, in early 2015 the FDA released a report of exempt mobile apps. However, should vendors market or intend these apps as a means for diagnosing, curing or preventing diseases, the FDA will consider them non-exempt from regulation.
By: Chris Bowen, ClearDATA