Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA's device center issues a significant draft guidance on the 510(k) program, plus a draft on appeals processes open to sponsors. More end-of-the-year regulatory developments.
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EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry.
New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.
The jury is still out on whether CDRH’s new standard operating procedures will improve continuity when a review team changes midstream.