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FDA Plan to Limit Old Predicates Not Happening Soon, 510(k) Regulator Says, MedTech Dive

Friday, May 3, 2019

MedTech Dive spoke with life sciences partner Michele Buenafe about the FDA’s proposed overhaul of the 510(k) program. Michele says in the article that “many medical device manufacturers have expressed concern about FDA’s proposal to potentially sunset certain 510(k) predicates.”

Read the full MedTech Dive* article.