On February 9, 2015, the Food and Drug Administration (FDA) released two guidance documents: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices and Mobile Medical Applications. Both guidance documents continue to reduce the range of products that the FDA intends to regulate.
The first guidance covering medical device data systems (MDDS) asserts that these products play an important role in advancing digital health while also posing a low risk to patients. Accordingly, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS. In essence, the FDA is stating that there are no regulatory requirements for MDDS, including: registration and listing, premarket review, postmarket reporting, and quality system regulation of manufacturers.
In an analogous manner, the mobile medical applications guidance asserts that the FDA intends to apply its regulatory oversight only to mobile apps that are medical devices—if the app’s functionality could pose a risk to a patient’s safety in the event of a malfunction. the FDA stated that the majority of mobile apps currently in market either do not require regulation, or the agency does not intend to regulate these apps.
- Most apps do not fit into a category that the FDA intends to regulate
- The FDA considers functionality rather than platform when classifying the regulatory category of an app
- The FDA intends to only apply its oversight authority to apps that could pose a risk to patient safety
- Distributers of mobile medical apps that do not engage in the manufacturing of those apps are not responsible for the apps themselves and won’t be subject to regulation (e.g., Google Play, iTunes App store, and BlackBerry App World)
- Since 2011, the FDA has issued a number of guidance documents that reduce the regulatory requirements for these types of technologies to facilitate continued innovation in the marketplace
In light of these guidances, Digitas Health LifeBrands recommends companies take the following actions:
- Review all apps in market and in development to determine which regulations apply
- Ensure your product does not make claims about use that inadvertently classify the app as a medical device
- Apps that provide patient-specific analysis, patient diagnosis, or treatment recommendations are the main focus of the FDA’s regulatory oversight. Consider the impact of these regulations before creating apps that fall into one of these categories
- Most apps will not fall into a regulated category. Consider the opportunities this creates for your product development
- Determine if your product is an MDDS. If it is, no regulatory requirements will be enforced by the Agency
– Noah Beytin, Director, Regulatory Review