Sierra Labs Blog | 510(k)

FDA 510(k) Applications for Medical Devices

By: Sierra Labs on 8/1/23 10:42

A Simple Guide to 510(k) Applications for Medical Devices

Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications

FDA's Refuse-to-Accept Policy for 510(k) Submissions

By: Sierra Labs on 6/8/23 12:40

6 Preliminary Questions Around FDA’s RTA Policy for 510(k)

Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions

Succesful Hardware Development Process

By: Sierra Labs on 12/17/20 11:54

The Secret to a Successful Hardware Development Process

What is the right approach to developing hardware-based medical devices?