In most of the world, regulatory bodies approve medical devices based on safety. Seems like common sense. But, in the U.S., the FDA approves medical devices based on both safety and effectiveness. It’s the “E” word that is largely responsible for the long and protracted clinical trials that delay approval of novel medical devices. Read More
Happy New Year! Healing Innovation hopes that Santa left you a great gift under the tree that you can enjoy in 2012. Disguised as Jolly Old Nick, the FDA left Healing Innovation a present that we have been wanting for years. The promise of continuity in FDA reviews.
Although it appears to have been released sometime in November, just about Christmas day we unwrapped a standard operating procedure (SOP) from the FDA called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission”.
The title of Scott Gottlieb’s Wall Street Journal article “How the FDA could cost you your life” is not only sensational, but misguided. I am no apologist for the FDA’s poor execution, weak resources and lack of transparency; however, the agency’s existence and culture are a direct response to what American society values. Read More
The medical device industry has been complaining for years about the extended review time for 510(k) FDA approvals. The Institute of Medicine (IOM) released its FDA commissioned report Friday, which recommended discarding the 510(k) process and replacing it with a more scientific approach. So, why is the medtech industry up in arms? Read More
I don’t want to become an FDA basher. It just seems like every year it is getting harder to push the medical device rock up the FDA hill. Speaking with peers, their perception has been similar, but last week the speculation was confirmed. Read More
An Investigational Device Exemption (IDE) approval is necessary before conducting FDA sanctioned medical device clinical trials. Companies often (around 200 times per year) utilize an informal pre-IDE process as a pre-cursor to the IDE application for the purpose of gaining insight from their FDA review team and presenting their product and testing or clinical plan. But, what seems like a no-brainer is not right for all projects, and a company needs to know to drop the informal interaction when it no longer serves its purpose. Read More
Many, if not most, medical device companies perform pilot clinical studies outside of the U.S. Cost reductions, avoiding a protracted FDA Investigational Device Exemption (IDE) approval process, and the ability to make design changes during the study without continual IDE amendments are the leading reasons to perform early studies outside the U.S (OUS). Read More
If you haven’t heard, the FDA has been publicizing their newly launched Medical Device Innovation Pathway. Besides the standard press releases, FDA’s Center for Devices and Radiological Health (CDRH) has created a 53-minute video starring Dr. Jeffrey Shuren, director of CDRH (see below) to spread the word. But, is the FDA really capable of fostering innovation outside a token project each year?
There are three FDA regulatory classes of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of FDA control. The lowest category of devices (Class I) provides the least burdensome FDA pathway and control, and applies to non-life sustaining tools and hand-held instruments. Read More
