FDA Provides New Final Rule on Medical Device Apps

We have previously posted blog articles regarding software applications used as medical devices and how they are affected by FDA regulations, but a new ruling by the FDA has clarified some of the uncertainty surrounding this type of technology. The recently published final rule regarding Medical Device Data Systems (MDDS) addresses several areas of concern regarding medical device apps.

The most important change introduced by the rule is a reclassification of certain Class III medical devices – specifically, mobile apps which are used in the collection, transmission or storage of patient data.

The FDA has declared that this specific type of software now falls under the Class I heading, which significantly opens up the market for medical device application development and knocks down many regulatory barriers for software companies eager to get a slice of this growing segment of the industry.

While this reclassification can be taken as a victory for medical device app developers, it is important to understand that Class I status also brings with it important restrictions. For example, while a Class I smartphone app that keeps track of a patient’s caloric intake or heart rate during exercise is acceptable under current regulations, one which uses that data in order to offer any type of consultation or medical advice would remain a Class III device. The takeaway for app designers is that helping patients keep track of personal health information as well as transmit that data to a qualified medical professional is perfectly acceptable for Class I devices, but anything more than that requires additional regulatory scrutiny.

This MDDS final rule is a small but important step towards a gradual streamlining and standardization of the regulatory process surrounding medical device apps. Although the speed of software development has traditionally been breakneck in all other segments of industry, the FDA’s mandate to protect the safety of the American public has required medical device application companies to see the market through a different, and less fast-paced lens. At MDCI, we feel that it is only reasonable to expect additional regulatory changes in the near future as the FDA develops additional guidance for dealing with medical device apps.

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Republished and adapted with permission from MDCI

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