FDA has decided to regulate mobile medical applications (MMAs) that are either:

  • for an intended use that has traditionally been considered a medical device, or
  • affect the performance or functionality of a currently regulated medical device.

Definitions:

  1. Mobile platform (MP): smartphones and tablets.
  2. Mobile application: software applications run on or tailored to an MP.
  3. MMA: an app that meets FDA's definition of "device” and is either:
  • used as an accessory to a regulated medical device; or
  • transforms an MP into a regulated medical device.

Your product is an MMA if it:

  • Is an extension of a regulated medical device for purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data.
  • Transforms or makes the MP into a regulated medical device by using attachments or sensors or similar medical device functions.
  • Allows the user to input patient-specific information and - using formulae or a processing algorithm - output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions.

Your product is NOT an MMA if it:

  • Is an electronic "copy" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received and does not use or contain any patient-specific information, but could show examples for a specific medical specialty.
  • Is solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness and is not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
  • Automates general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
  • Generally assists users and not marketed for medical use.
  • Performs the functionality of EHR or PHR systems.

You are an MMA manufacturer if you:

  • Initiate specifications, designs, labels, or create a software system or application in whole or from multiple software components.
  • Create, design, develop, label, re-label, remanufacture, modify, or create a software system from multiple components.
  • Provide MMA functionality through a "web service" or "web support" for use on an MP.
  • Initiate specifications or requirements for MMAs or procure product development/manufacturing services from other individuals or entities (second party) for subsequent commercial distribution.
  • Create an MMA intended to be used on an MP, or that manufactures a mobile app to be supported by hardware attachments to the mobile platform with a device intended use.
  • Commercially market an MP with an intended use of, or to be used with, a device.

You are NOT an MMA manufacturer if you:

  • Exclusively distribute (and not manufacture) MMAs.
  • Solely distribute or market your MP with no device intended use.

Additional Points

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:

Accessories

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.

Input Analyzers/Calculators

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:

  • Products that feature one or more software components, parts, or accessories.
  • Devices that are composed solely of software.
  • Computer- or software-based devices intended to be used for the electronic transfer, storage, display, and/or format conversion of medical device data – called Medical Device Data Systems (MDDSs).