Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive SummaryContura’s Aquamid advisory panel delayed
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Hospital groups meet with OMB on UDI rule. Electronic Medical Device Reporting final rule reaches OMB. More regulatory news.
Group urges FDA to pull Stryker’s Wingspan stent from the market, among other regulatory updates.
FDA issues procedures governing reviewers' requests for additional pre-market data from sponsors. Agency extends comment period for its de novo and 510(k) modification draft guidances. More regulatory briefs.