Inappropriate attack on device development.

摘要

A recent article has criticized the device approval process, specifically the 5,10 K pathway to device approval. The 5,10 K process permits approval of devices that have a predicate, previously approved similar device(s) by showing similarities to the approved device rather than undergoing clinical trials. The authors of the study claim that more recalls occur for the device approval under 5,10 K than those undergoing clinical trials, and thus, the 5,10 K process is not appropriate for lifesaving devices.