The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The FDA announced open registration for a series of workshops on the "adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems."
The meetings will cover issues related to UDIs, a system for tracking medical devices in efforts to aid device recalls and other safety measures.
The workshop roster includes:
By Stewart Eisenhart, Emergo Group
A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays.
A U.S. House subcommittee hearing yesterday on the FDA’s oversight of medical devices devolved along sadly predictable party lines, with Republicans charging that the federal watchdog agency is strangling med-tech innovation and Democrats looking to undermine the reports behind the GOP’s arguments.
Which is too bad, because all the political noise obscured the real and pressing cause behind any problems at the Center for Devices & Radiological Health.
“To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”– David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
House Democrats are taking a new tactic in defending the FDA against criticism from the GOP and the medical device industry; attacking the source.
Democratic leaders distributed a memo to members of the House Energy & Commerce Committee’s oversight subcommittee this morning that takes aim at claims made in two well-publicized studies the medical device industry has used in supporting claims that the FDA is impeding innovation from getting to the U.S. market.
MASSDEVICE ON CALL — Health insurance providers may have to offer prescription contraception at no up-front cost to women if Health & Human Services secretary Katherine Sebelius accepts the recommendations of the Institute of Medicine.
Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, the FDA said today.
The FDA released draft guidance today informing manufacturers, distributors and other med-tech entities about the agency’s intentions to regulate mobile health apps as medical devices.
Medical applications on smartphones, tablets and other mobile devices range from programs that allow patients to watch their calorie intake or keep records of blood pressure readings to apps that allow physicians to view and share medical images on the go.
Dr. Jeffrey Shuren, head of the FDA’s medical device division, is planning to be in San Francisco in September for the last in a series of town hall-style public meetings for 2011.
The west-coast meeting is the last in a trio of events during which agency officials engage in public dialogue regarding issues of concern to the medical device community. This year’s other meetings were held in Orlando, Fla., in May and in Dallas, Texas, in March.
The House Energy & Commerce Committee’s oversight subcommittee is set to examine the FDA’s performance in clearing medical devices for the U.S. market in a hearing set for this week on Capitol Hill.
On July 20, the GOP-led committee will hold its “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” at 10:30 a.m.
The committee said it will look at the following issues:
The medical device industry is keeping the pressure on Congress to push for a vote to repeal the medical device tax, a 2.3 percent levy on U.S. sales of medical equipment, which was contained in last year’s landmark health care reform law.
More than 400 medical device companies, industry councils and other stakeholders signed a letter addressed to leaders in both the House of Representatives and Senate, asking legislators to repeal the tax outright.
