The American Association for Clinical Chemistry (AACC) offers a webinar titled, “[removed]Reforming the 510(K) Process: What’s on the Horizon[/removed]” on Wednesday, May 23,
The Food and Drug Administration (FDA) is working to improve the 510(k) medical device review process. The agency is seeking to make it more transparent, timely, and accountable. In 2011, the FDA completed an evaluation of the review process, generating 25 proposals for change. In addition, the agency funded an IOM report that promoted additional ideas for change.
The FDA is currently drafting and implementing many of these recommendations. Already the agency has issued draft guidance on the ‘substantial equivalence’ of predicate devices, as well one that streamlines the de novo process. More guidance and actions are on the way. Join us to hear an FDA update on these and other issues under review.
Also, get the latest on the FDA/Industry user fee agreement and the clearance of devices involving recalled medical devices. Alberto Gutierrez, PhD, director of the FDA’s office of in vitro diagnostic device evaluation and safety will give a 20-minute update on the agency’s efforts, leaving 25 minutes for you questions.
