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The FDA 510(k) database is a key resource for device manufacturers looking to better understand the regulatory landscape for medical devices in the United States. The 510(k) database contains information about the premarket notification process for medical devices, which is required by the FDA in order for a device to be legally marketed in the …
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 …