How Does a Medical Device Get Approved by the FDA?
April 24th, 2012 tmccoy
https://s3.amazonaws.com/lvs-yourlawyer/106-yourlawyer-falkowitz-medical-device-approval-matters.mp4
Each time a manufacturer develops a medical product for the public, it must be given approval. Approval comes from the Food and Drug Administration, commonly called the FDA.
First, the medical devices are placed into one of 3 classes based on the risk level they may pose to a patient. The FDA then puts the device through one of 2 approval processes.
One process – the 510K – is much shorter than the other process, because the FDA allows approval is the company can prove that their product is “very similar” to another on the market. This allows the company to skip a lot of the testing and go straight to the market. PMA (or Pre-Market Approval) is a much more stringent process. The FDA has the manufacturer run a large battery of tests to make sure their reports contain sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use. The FDA allows public access to the list of approved products for your marketplace on their website.
To learn more about defective medical devices, I encourage you to watch the video above and to explore our educational website. If you have legal questions, I want you to call me at (800) 800-9797. I welcome your call.
