Search for:
  • Home/
  • Month: July 2024

What is the US FDA 510K, and how can I obtain it in 2024? – what is the difference between fda 513g and fda 510k – regpro.us

The USFDA 510(k) process is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). Here are [...]

What is the US FDA 510K, and how can I obtain it in 2024? – what is the decision date for fda 510k – regpro.us

The USFDA 510(k) process is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). Here are [...]