Medical Devices

CMS late Thursday evening (Feb. 23) issued a 455-page proposed rule on the second stage of an electronic-health records program that includes new criteria that hospitals and doctors must meet in return for bonus payments. The second stage uses the same approach as the first stage: most criteria are required and providers are given a list of additional criteria from which they must choose a few.

FDA's top medical device official signaled that resources will be key in getting the agency behind legislative reforms pending in Congress, saying that proposals like de novo reform do not require more money, but other pending recommendations such as requiring detailed summaries of agency approval decisions were taken off the table during user fee negotiations because they would divert resources away from meeting user fee goals.

Consumer safety advocates are unveiling a broad medical device reform agenda as they increase lobbying efforts on Capitol Hill, with groups focusing on more rigorous approval for implantable devices, restrictions on using recalled predicates, increased requirements for post-market studies, implementation of the delayed unique identifier system and a national device registry, and greater scrutiny of direct-to-consumer medical device advertising. A safety advocate said there is momentum in the Senate to include some reforms in the user fee act legislation.

A bipartisan duo of House lawmakers Wednesday (Feb. 8) introduced a bill that would require FDA finalize a pediatric medical device rule mandating device manufacturers include in applications potential pediatric populations that could benefit from the device, a requirement that the agency withdrew in 2010 after objections from industry. The legislation -- backed by Reps. Ed Markey (D-MA) and Mike Rogers (R-MI) -- would reauthorize a 2007 law that outlines a grant program and profit incentives for pediatric humanitarian use devices.

CMS plans to move forward with its delayed power wheelchair demonstration this summer, but revealed on Friday that it will abandon the demo's prepay phase and significantly alter its prior authorization aspect in response to complaints from home medical equipment suppliers. The agency had delayed the prepayment demo after a bipartisan group of 22 House lawmakers in late December urged CMS to halt it, nd now is expected to start demo in June.

Two key lawmakers on the Senate health committee are pushing legislation to reform the de novo pathway for medical devices that incorporates elements of other proposals that would remove a requirement to enter and be rejected from the 510(k) pathway before being allowed to file a de novo submission, while also addressing concerns about the time FDA has to review these devices. The latest legislative package is expected to become a “baseline” for Senate reform in this area, according to sources.

FDA informed a bipartisan group of Minnesota lawmakers pushing device reforms that some of their proposals are wrapped into the tentative device user fee deal announced Wednesday, and said the agency would take steps internally to address some of their other concerns, according to sources and a letter FDA sent the lawmakers prior to a Feb. 1 meeting between the lawmakers and agency Commissioner Margaret Hamburg.

FDA Commissioner Margaret Hamburg signaled to House lawmakers Wednesday (Feb. 1) that the agency does not need a legislative fix to address conflict-of-interest policies that may be contributing to problems with filling vacant positions on advisory committees, saying the agency is engaging stakeholders on the issue and regulatory science collaborations could also provide FDA with needed expertise.

FDA is pushing ahead with its innovation pathway for novel medical devices with a pilot project for end-stage renal disease that one stakeholder said could provide inroads to comparative effectiveness research and despite calls from the medical device industry for the agency to focus on bringing greater efficiency and consistency to the overall review process.