Washington Roundup, November-December 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover the post-election picture, pending reimbursement reductions for interventional cardiologists, and new guidance on PMA and 510(k) submission reviews.

With President Obama’s re-election November 6th, the administration is expected to accelerate implementation of a range of health care policies. At the top of the list are provisions of the 2010 Affordable Care Act, which were directly threatened by Republican candidate Mitt Romney, who had vowed to repeal the law, and are now on more solid ground. But the politics of the election season also tend to cause federal agencies to delay rollout of a range of the other, lower-profile policies. Elections trigger an extended absence of lawmakers on Capitol Hill, and members of Congress are now returning to Washington to address dramatic year-end fiscal issues. Here is a guide to some of the important policies and events to look out for in the short term.

Public suspense is shifting focus from electoral politics to high-stakes congressional negotiations. The lame-duck Congress has returned to Washington to...

More from Legislation

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
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A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

More from Policy & Regulation

Global Medtech Guidance Tracker: June 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.