In Case You Missed It: Top 10 Gray Sheet Stories In May
This article was originally published in The Gray Sheet
Executive Summary
Our reporting on a halted Medtronic stent-graft trial was the most popular online story last month in The Gray Sheet. Also attracting significant attention in May: coverage of the big regulatory changes afoot in Europe, and the growing efforts by FDA leadership to push forward with an envisioned "national evaluation system" for devices.
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Agreement Announced On EU Reg Reforms, But Consensus Is Not Complete
The Council of the European Union heralded an agreement on new EU-wide regulations for devices and diagnostics following years of preparation and negotiation. But it appears that one of the three main segments of the government structure, the European Commission, still has misgivings about single-use device reprocessing language, and one other issue, in the negotiated texts, which could make them vulnerable.
FDA '522' Guidance: 15-Month Deadline To Comply With Postmarket Order
The agency has issued a final guidance on Sec. 522 postmarket study orders about five years after a draft version. In the interim, Congress stipulated a 15-month deadline for companies to start the FDA-mandated studies, a requirement emphasized in the new document.
FDA Chief Counsel Addresses Staff Turnover, Device Bans
Staff turnover in FDA's Office of the Chief Counsel is a positive, says the agency's top lawyer Elizabeth Dickinson. The chief counsel also discussed recent device bans, off-label communication policy efforts and the agency’s ongoing transparency initiative at the annual Food & Drug Law Institute conference.