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BioWorld - Monday, December 11, 2023
Home » Blogs » BioWorld MedTech Perspectives

BioWorld MedTech Perspectives
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Controversial 510(k) changes still up in the air

March 1, 2011
By Holland Johnson
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In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed. Among the most contentious recommendations being postponed was one for CDRH...
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