FDA issues draft guidance of mobile medical applications

The U.S. Food and Drug Administration (FDA) released their draft guidance today for certain mobile applications specific to medicine or healthcare that are designed for use on smartphones and other mobile computing devices. This approach clearly outlines and focuses only on a select group of “medical” applications and will not regulate the sale or general consumer use of smartphones or tablets.1

Fantastic news for all in the medical, pharmaceutical, health and wellness industries including marketing, legal and regulatory departments as well as healthcare providers/service centers who have interest in developing mobile medical apps themselves--which we have seen much of over the past year.

According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015. Mobile medical applications or "mobile medical apps," include a variety of functions, ranging from1:

  • monitoring calorie intake
  • helping people maintain a healthy weight
  • allowing doctors to view a patient’s radiology images on their mobile communications device.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."1


So what does the guidance address?

The agency’s draft guidance is very clear and straightforward. It defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

  1. are used as an accessory to medical device already regulated by the FDA (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet);1
  2. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).1
  3. It also outlines what apps will NOT be regulated by the FDA (also of major importance to anyone considering developing an app).

Appendix A provides and exemplary list of medical functionalities to illustrate types of mobile apps.

Appendix B lists Examples of current regulated devices, the class according to which they are regulated, and their regulation numbers.

Appendix C provides a high level description of some select regulatory requirements for medical devices, including mobile medical apps including:

1. Establishment Registration and Medical Device Listing

2. Investigational Device Exemption (IDE) requirements

3. Labeling requirements

4. Premarket submission for approval or clearance

5. Quality System Regulation (QSR)

6. Medical Device Reporting (MDR) (Adverse event reporting)

7. Correcting Problems

Appendix D provides a plethora of Additional Resources, software and instructional design recommendations and industry peer reviewed journals articles, although most are outdated back to 2006-1998 and may not be relevant in today’s mobile and information technology landscape.


What does the guidance not address?

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).1

The agency is seeking public input on this approach and comments can be submitted for 90 days in 2 ways and the FDA will update the guidance based on feedback received.


Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in theFederal Register.

In writing

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852


Source documentation of guidance:

1. FDA press release here

Full draft guidance PDF here or view it online here