The HDE Program was created to address the difficult challenge of gathering clinical evidence to meet FDA ' s standard of reasonable assurance of the safety & effectiveness of the #MedicalDevices used to treat rare diseases. Find out about the HDE Program https://go.usa.gov/xd8bG  

The HDE Program was created to address the difficult challenge of gathering clinical evidence to meet FDA's standard of reasonable assurance of the safety & effectiveness of the #MedicalDevices used to treat rare diseases. Find out about the HDE Program https://go.usa.gov/xd8bG 

Source: Food and Drug Adminstration (FDA): CDRHNew - February 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news