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U.S. Department of Health and Human Services

Medical Devices

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Mobile Medical Applications

Submit a comment buttonMobile applications are software programs that run on smartphones and other mobile communications devices. Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care.

Consumers use mobile medical applications to manage their own health and wellness. Health care professionals are using these applications to improve and facilitate patient care. These applications include a wide range of functions from allowing individuals to monitor their calorie intake for healthy weight maintenance, to allowing doctors to view a patient's X-rays on their mobile communications device.

The FDA encourages further development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information very quickly.

The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of mobile medical applications with a clear and predictable outlines of our expectations.

Through draft guidance release on July 19, 2011 the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.

The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 19, 2011.

  • Submit electronic comments on the draft guidance to http://www.regulations.gov.
  • Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2011-D-0530].
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