US Regulatory Roundup, November 2018: Press Scrutiny, FDA Reforms And The Midterms
Executive Summary
The global investigative journalism spotlight on the medtech space had major impact at the end of November and now underlie discussions of FDA reforms, even if the agency was already working on them. Meanwhile, there was a US midterm election in November. Here's the most popular US regulation and policy stories from last month.
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Pendulum To Swing To More Congressional Oversight Of FDA Device Regs, Hill Experts Say
In the context of a global investigation of the device industry and a change in power in the US House, health-policy experts say oversight by Congress of FDA's regulation of devices in 2019 is likely to swing incrementally away from ensuring innovation of products and easy market access, toward greater assurance of product safety before devices reach the market.
Nudging Firms To Ditch Older Predicates: A Step In US FDA's Planned 510(k) Reforms
FDA says it might start publicizing which marketed devices were cleared based on a predicate at least 10 years old. This "market-based approach" is intended to induce companies to modernize their devices, while the agency also pursues other reforms that might require congressional approval.
FDA Looks To Lead World In Post-Market Device Surveillance With Safety Plan, Investments
US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.