Fact Based List:

Mobile Apps for which FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act)

Submitted by Anonymous on Thu, 09/26/2013 - 14:33


  1. Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions
  2. Provide patients with simple tools to organize and track their health information
  3. Provide easy access to information related to patients’ health conditions or treatments
  4. Help patients document, show, or communicate potential medical conditions to health care providers
  5. Automate simple tasks for health care providers
  6. Enable patients or providers to interact with Personal Health Record ( PHR ) or Electronic Health Record (EHR) systems


Source: U.S. Department of Health and Human Services Food and Drug Administration
Source URL: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulation...



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