What is an FDA 510(k) Submission
by Fidelma Conway
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices need to go through this regulatory pathway? How do you prepare your submission? What happens after you make your 510k submission? Below is an introduction to FDA 510(k) submissions. What is a 510(k) Submission? A 510(k) submission is a pre-market notification that you must submit...
