Looking for the best pizza in town? There’s an app for that. Need driving directions to the restaurant? There’s an app for that. Want to send the reading from your glucose meter to your doctor after eating one or two slices too many? There’s even an app for that, and that app has FDA 510(k) clearance.
Everybody wants to go mobile, but unlike the company that sold me the app that helped me find my car in the mall parking lot last week, medical device manufacturers are required to concern themselves with regulatory compliance. FDA wants innovators to advance medical technology but not to the detriment of safety or efficacy.
To this end, FDA published a draft guidance on mobile medical applications in July 2011. Although not binding, the draft guidance represents the agency’s most up-to-date thinking on the use of mobile technology in medical devices. The guidance is detailed and somewhat lengthy, so while a comprehensive review is not possible in this article, a presentation of the highlights should help to jumpstart its understanding.
Following an introduction and background discussion, the guidance defines several terms, including the following:
- Mobile platform: smart phones, tablets, and personal digital assistants (PDA).
- Mobile app: software that can run on a mobile platform or a web-based application that is tailored to a mobile platform but executed on a server.
- Mobile medical app: a mobile app that is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.
- Regulated medical device: a product that meets the definition of medical device in section 201(h) of the Food, Drugs and Cosmetics Act (FD&C Act) and has undergone classification by FDA.
- Mobile medical app manufacturer: any person or entity that manufactures mobile medical apps. Note that mobile platform manufacturers (e.g., Apple) are excluded from the definition along with distributors (e.g., App Store).
- The definitions emphasize the importance of intended use in determining what is a mobile medical app and what is not.
Scope of Application
The scope of application is mobile medical apps, period. It does not address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. (FDA intends to address these topics separately).
Importantly, the guidance also defines several types of mobile apps that FDA does not consider mobile medical apps. Such mobile apps include or do the following:
- Electronic “copies” of medical textbooks, teaching aids, or reference materials that are solely used to provide clinicians with training or reinforce training previously received;
- Log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness;
- Automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions;
- Generic aids that assist users but are not commercially marketed for a specific medical indication; and
- Perform the functionality of an electronic health record system or personal health record system.
FDA’s regulatory approach to mobile medical apps is summarized as follows:
- FDA intends to apply risk to determine which mobile medical apps will be subject to regulatory oversight. It will apply regulatory discretion to mobile medical apps that might meet the medical device definition (per the FD&C Act) but do not cross a risk threshold. (Manufacturers may elect to register and list mobile medical apps that are not subject to regulatory oversight).
- FDA strongly recommends that manufacturers of mobile medical apps that meet the FD&C Act’s definition of a medical device follow the Quality System Regulation (21 CFR Part 820).
- Manufacturers of mobile medical apps that are subject to regulatory oversight must meet the requirements associated with the applicable device classification.
- FDA is seeking comments on how it should approach mobile medical apps that are accessories to regulated medical devices to ensure safety and efficacy.
- If a mobile medical app adds medical device functionality to a mobile platform, the mobile medical app manufacturer must meet the classification requirements applicable to that functionality.
The guidance lists three examples of mobile medical apps to which FDA will apply regulatory oversight, and identifies several classification categories for mobile medical apps. Some of the identified categories are medical device data systems (21 CFR 880.6310), glucose test systems (862.1435), and drug dose calculators (868.1890). (Manufacturers should refer to the actual guidance for additional identified classification categories).
The guidance describes the regulatory requirements for mobile medical app manufacturers and those for distributors. The requirements for manufactures are based on device classification and are the same requirements that apply to any manufacturer of regulated medical devices. The only requirement for distributors is cooperation in the corrections and removal process. (The mobile medical app manufacturer is required to report corrections and removals).
As previously stated, the guidance is in draft form and may change. This is especially true if FDA receives and incorporates comments concerning the regulation of mobile medical apps as accessories. The bottom line is that any medical device manufacturer contemplating the mobile market would be well advised to become familiar with this FDA draft guidance.
Marc Goodman is a senior consultant for the consulting firm of Noblitt & Rueland (www.fdaconsulting.com), which provides consulting and training services for medical device and IVD manufacturers. For more than 25 years, he has specialized in FDA and international compliance in the areas of software quality management, software validation, FDA electronic recordkeeping, software risk/hazard management, and software submissions, including 510(k)’s, for the medical device industry. He has assisted international companies ranging in size from less than $1 million in sales to Fortune 100 companies. He is a member of the Institute for Electrical and Electronic Engineers (IEEE) and the IEEE Computer Society. He holds a master's degree in computer science and a bachelor’s degree in economics from the University of Pittsburgh. He can be contacted via e-mail at email@example.com.