The US Food and Drug Administration invited UCSC Extension instructor Craig Coombs, RAC, to speak at the “510k Strengthening” meeting in Gaithersburg, Maryland on February 18. He was also one of 7 non-FDA members on the final Round Table Panel. Coombs currently teaches the “Regulatory Submissions: Devices and Diagnostics” and “Global Medical Device Submissions and Strategy” courses at UCSC Extension.
This meeting was part of an effort by the FDA to improve the 510k submission process, ahead of the recommendations by the Institute of Medicine (IOM) committee that is independently reviewing the program. Medical device manufacturers use the 510k process to gain market clearance for their low to medium risk devices (Class I & II). Nearly 95% of all medical devices are Class I or II.
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