Regulatory News In Brief

The Fifth Annual Sentinel Initiative Public Workshop will take place Jan. 31 in Washington, D.C. Participants will hear an update on FDA’s Sentinel Initiative, which aims to improve the agency's ability to track the safety of medical products after they reach the market. Medical devices were added to the Sentinel Initiative with this year's passage of the FDA Safety and Innovation Act. (See Also see "Final FDA Bill: Device Provisions" - Medtech Insight, 25 June, 2012..) Attendees will also discuss findings from Mini-Sentinel protocol-based evaluations; current and future collaborations and initiative expansions; and stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety issues that require regulatory actions. The one-day workshop will be hosted by the Brookings Institution's Engelberg Center for Health Care Reform. Registration is required.

SPI, a plastics industry trade association, released a white paper Dec.11 on marketing claims related to phthalates in medical devices. Phthalates are commonly used as vinyl softeners in medical devices,...