When new medical devices are approved by the FDA, there is still uncertainty about their effectiveness. Unlike biotech products, device makers do not have to provide as much clinical data for approval. After approval, tracking device performance in the real world is challenging due to lack of comprehensive databases and difficulties in tracking unique device identification numbers. This lack of data makes it hard for researchers to observe device performance trends and for hospitals to contact patients in case of device recalls. Comprehensive medical device databases are rare, making it difficult to evaluate the real-world performance of new medical devices.
June 24, 2024
Artificial Intelligence
FDAcop
