Assessing Innovations For Medical Device Development
Public Affairs Advisor Ethan Jorgensen-Earp wrote an article on the FDA's decision to speed up the approval process on Class III medical devices that sustain life and function for individuals. The FDA Center for Devices and Radiological Health (CDRH) relies on the premarket approval (PMA) which requires sponsors to submit substantial data and evidence showing that the devices are safe and effective. These decisions are known as the 510(k) process which took 400 days in 2008, but has been significantly decreased to no more than 200 days in 2018. The FDA released new guidance in an attempt to revamp the program to help the agency meet the constant demand for safe and effective device technology.