In Fall 2022, the documentary “The Bleeding Edge” revealed shocking information about the FDA’s medical device clearance process, highlighting how devices can be fast-tracked without clinical trials, leading to patient injuries. The process includes 510(k) clearance, which allows new devices to be marketed if equivalent to existing ones without trials. Digging into the data, the author investigated 85,791 510(k) applications manually due to insufficient public records, revealing that 74% devices had predicates. The data was stored in a SQLite database for analysis. A website 510k.fyi was set up to visualize the data, surprising with its use of SQLite over graph databases, providing insights into the medical device approval process.
https://wcedmisten.fyi/post/medical-device-analysis/