Tension in the medical device industry is building as the industry continues to speculate about what the FDA will unveil regarding changes to its premarket notification submission process, otherwise known as the 510(k) process. More transparency, consistency, and predictability appear to be just a few of the buzz words bantered about when the FDA discusses anticipated changes to the medical device submission process. For years, the 510(k) process has been under intense scrutiny by the Senate and House as well as by critics within the FDA. The most common theme is ensuring that public safety and efficacy of approved medical devices is not shortchanged in the name of innovation or as a concession to political pressure. Scrutiny has intensified since the 2008 clearance of ReGen Biologics' knee repair device and allegations of congressional lobbying of the FDA to clear the product. In an effort to objectively evaluate the case for more rigorous scientific review and approval requirements, the FDA has spent $1.3 million on a commissioned report from the Institute of Medicine (IOM) to conduct a review of the 510(k) program and recommend changes. Although final IOM findings and report are not due out until early 2011, the task force conducted a public meeting in late June, 2010. During the session the committee indicated that, among other things, they were concerned about the FDA's compliance and surveillance tools for 510(k) products

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Seminar Date:
May 03, 2011
Medical Device Regulations - A Preview of Things to Comeā€¦
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