August 3, 2011
FDA has decided to regulate mobile medical applications (MMAs) that are either:
Your product is an MMA if it:
Your product is NOT an MMA if it:
You are an MMA manufacturer if you:
You are NOT an MMA manufacturer if you:
General comments on the points above are due October 19, 2011. Stakeholders are urged to comment on any aspect of the draft guidance.
FDA also seeks comments specifically on the following related topics:
FDA has typically expected that the manufacturer of an accessory would meet the requirements associated with the classification of the connected device. However, this approach may not be well-suited for MMAs that serve as an accessory to another medical device because of the wide variety of functions MMAs can potentially perform. Therefore, FDA is seeking comment on how it should approach MMAs that are accessories to other medical devices so safety and effectiveness can be reasonably assured. Mobile medical devices that are intended to be used as accessories to a regulated medical device may do so for purposes of (a) displaying, analyzing, storing, or transmitting patient-specific medical device data, or (b) controlling the operation, function, or energy source of the medical device.
Some MMAs are intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device. The implications of these analyses and interpretations may pose a wide range of risks to public health and patient safety. Requiring such MMAs to comply with the same requirements as their connected devices may not be appropriate in some cases. For example, analysis of class I device information along with other demographic information can result in an interpretation of a highly acute patient condition, which presents a greater risk than the connected class I device. On the other hand, an analysis or interpretation of data from class II or class III devices can lead to a simple informational result, with minimal implications or risks to public health and patient safety—in other words, a level of risk more characteristic of a class I device. The FDA has previously classified software that calculates a drug dose based on a patients height, weight, mass, and other patient-specific information as a "Drug Dose Calculator" under 21 CFR 868.1890. The FDA encourages manufacturers of such MMAs to contact the Agency to determine the classification of their mobile app. In addition, the FDA seeks public comment on whether and how it can provide greater clarity for these types of MMAs.
FDA will exercise enforcement discretion for mobile apps that do not meet the definition of an MMA but may meet the FD&C Act's definition of a device. However, FDA strongly recommends that manufacturers of those apps follow QSR, including GMP, in the design and development of their MMAs and initiate prompt corrections to their MMAs, when appropriate, to prevent patient and user harm.
FDA will issue future separate guidance on wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. Future guidance will also be available for any other mobile apps that are outside the scope of the draft MMA guidance but for which performance monitoring indicates additional or different actions are necessary to protect the public health. A manufacturer may, however, at its discretion, elect to register and list, and to seek approval or clearance for such mobile apps with the FDA at this time.
If your products fit into any of the following categories, you are not under the MMA guidance but instead already regulated by existing software policy:
McGuireWoods LLP Healthcare Group
McGuireWoods offers an experienced team of more than 50 lawyers well-versed in serving the needs of the healthcare, pharmaceutical, life sciences and medical device sectors. We understand the daunting array of legal and business issues our clients face, and we work tirelessly to find effective solutions to their daily challenges.