As introduced in OnemataDC’s U.S. Medical Device Regulations article, high risk medical devices or Class III devices, require a successful Premarket Approval (PMA) application prior to being legally marketed to the public. Per the FDA, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
Class III devices fall under the U.S. Food and Drug Administration (FDA)’s most rigorous approval process and require an “independent demonstration of safety and effectiveness” of the medical device. With so much at stake with life-or-death devices, proactive planning with documented scientific evidence, ongoing use of high-quality components and proven manufacturing standards are the best way to ensure not only FDA approval of your medical device, but also to reduce safety incidents post-commercialization.
Finding an experienced partner to help navigate the PMA process is paramount to a successful approval and launch of a Class III medical device. OnemataDC’s experienced team are experts in the PMA process and is ready to help guide you through to FDA approval and a successful launch of your medical device.
If you have questions about the PMA process, or need help with your PMA application, please reach out to speak with a member of our team.