(Reuters) - The U.S. Food and Drug Administration proposed on Tuesday a more collaborative approach aimed at speeding up marketing approval for high-risk medical devices intended to treat patients with serious conditions that have no other treatment options. The proposed Expedited Access Premarket Approval Application program would feature earlier and more frequent interactions between companies and FDA staff. The program is not a new pathway to market, the FDA said, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market. The FDA issued a rule in September that requires device manufacturers to put unique codes on their products that will allow regulators to track and monitor them in the event of a safety problem. via Health News Headlines - Yahoo News Read More Here..
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