“U.S. health officials said Nov. 26 they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments.”
“The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients…”
“As generations of devices have been cleared via the FDA’s main review process, medical products have become increasingly complex and often barely resemble the decades-old “predicates” they claim to reference. Devices cleared through this system, known as the 510(k), include imaging scanners, computerized drug pumps, artificial joints, and spinal implants…” Read the full article here.
Source: FDA to overhaul long-criticized medical device system – November 27, 2018. Health Management Technology.
