Page 213 - Safety Risk Management for Medical Devices

192 Safety Risk Management for Medical Devices

When making a decision on the acceptability of risks for the potential benefits,
the deficiencies in current therapies should be identified from a critical and compre-
hensive review of relevant published literature to ascertain whether the investigative
device addresses a significant gap in the currently available healthcare. If there is no
significant gap, then the investigative device must show an improved or at least
equivalent benefit/risk profile compared to existing products or therapies.