Regulatory Affairs, SaMD & Digital Health Expert
I like to write about people, the places they live and the things with which they choose to surround themselves. Here are some of my favorite pieces that made it into Article.
The FDA 510(k) database is a critical tool for ensuring the safety and effectiveness of medical devices in the United States. This database contains information on all medical devices that have been cleared through the 510(k) pathway, which is a premarket submission made to the FDA to demonstrate that the device is substantially equivalent to …
Navigating the FDA 510(k) Database: A Comprehensive Guide The FDA 510(k) database is a valuable resource for healthcare professionals, medical device manufacturers, and the general public. This database contains information about medical devices that have been cleared for marketing by the FDA, as well as detailed summaries of their safety and effectiveness. Accessing the FDA …