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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, Created 09/26/2013 - 14:33
- Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions
- Provide patients with simple tools to organize and track their health information
- Provide easy access to information related to patients’ health conditions or treatments
- Help patients document, show, or communicate potential medical conditions to health care providers
- Automate simple tasks for health care providers
- 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...