May 12, 2023 | White Paper
Are you in early stage development of a device or device-led combination product? The FDA has rolled out a number of initiatives over the past several years to facilitate more timely access for patients to innovative medical devices and technologies. One such...
Apr 3, 2023 | White Paper
Being in unchartered territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high...
Feb 20, 2023 | White Paper
Doesn’t every manufacturer dream of new product development occurring in concert with FDA’s real time accelerated submission process? Well, here’s your chance! This white paper is to clear up any confusion regarding navigation of the Breakthrough Devices Program. It...
