FDA Classification: Find the premarket pathway for your medical device

Haylee Bosshard
March 5, 2021
6:02 pm

If you want to get your medical device to market in the U.S. you need to know its classification. To do this you need to:

Search the FDA classification database, the device panel, or check your predicate device to find your device.
Read the regulation for your device to see the classification and if there are any exemptions.
Follow the corresponding market approval process according to the classification.

Haylee Bosshard

Haylee is the CEO and founder of Conformify and has worked in the medical devices industry for a number of years. Haylee is on a mission to help companies to build effective, light-weight quality and regulatory processes that bring their medical device to market efficiently and with the highest quality.

FDA Classification: Find the premarket pathway for your medical device

Services

Resources

About