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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring
This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and ...
https://www.fda.gov/medical-devices/digital-health/wireless-medical-devices
Description. Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to support ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/internetsocial-media-platforms-character-space-limitations-presenting-risk-and-benefit-information
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Internet/Social Media Platforms with Character Space Limitations:...
https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UCM277529.pdf
Human Services Food and Drug Administration ... FDA’s withdrawn guidance on the monitoring of clinical investigations does not reflect FDA’s current ... To inform industry of FDA’s support ...
https://www.fda.gov/about-fda/fda-basics/fda-fundamentals
FDA Fundamentals. The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates ...
https://mhealthintelligence.com/news/remote-patient-monitoring-technologies-addressed-by-fda
Jul 31, 2015 · July 31, 2015 - The remote patient monitoring market is continually advancing throughout the healthcare industry with new products and technologies impacting the market on a constant basis. For example, the Food and Drug Administration (FDA) recently confirmed that the company Sentrian’s remote patient monitoring solution could be defined as a medical device, which would give the FDA …
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