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Radio Frequency Wireless Technology in Medical …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-technology-medical-devices-guidance-industry-and-fda-staff
- Center for Devices and Radiological Health FDA has developed this guidance document to assist industry and FDA staff in identifying and appropriately addressing specific considerations...
Wireless Medical Devices | FDA
- https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices
- Medical devices that incorporate wireless technology introduce some unique risks that should be addressed. The Radio Frequency Wireless Technology in Medical Devices …
Radio Frequency Wireless Technology in Medical …
- https://www.federalregister.gov/documents/2013/08/14/2013-19686/radio-frequency-wireless-technology-in-medical-devices-guidance-for-industry-and-food-and-drug
- This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless …
Recognized Consensus Standards - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=35548
- This TIR applies to medical devices and systems (also known as medical electrical equipment) that incorporate RF wireless technology used to perform or control a …
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