Revising FDA 510(k) Poses Challenges For Device Makers

Law360 (December 12, 2018, 2:03 PM EST) -- The U.S. Food and Drug Administration's Section 510(k) process, by which a medical device manufacturer can bring a product to market based on the premise that the proposed device is substantially equivalent to an already legally marketed "predicate device," has been viewed as a streamlined pathway to market when compared to more rigorous evidentiary requirements of premarket approval. Critics, however, have cited patient safety issues allegedly caused by the "lower" standards needed for 510(k) clearance. 

Last week, the FDA announced its plans to "modernize" the 510(k) regulatory pathway as part of its Medical Device Safety Action Plan, by: (1) "encouraging product developers" to...

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