FDA Commissioner Margaret A. Hamburg, has released a blueprint that FDA says is designed to provide immediate steps the agency can take to drive biomedical innovation while also improving the health of Americans.
The blueprint, “Driving Biomedical Innovation: Initiatives for Improving Products for
Patients,” addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development.
“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” says Hamburg. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
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Authors of the largest survey to date on the effectiveness of the premarket notification (510(k) medical device review process at FDA have submitted an official comment and analysis to the agency, comparing their survey findings to those of the recent Institute of Medicine (IOM) committee report about the 510(k) process.
Funded by the Institute for Health Technology Studies (InHealth), the survey found that within the past three years, 76% of survey respondents’ companies chose to bring a specific device to market first outside of the United States. Their reasons? One in five (22%) blame the high cost of conducting clinical trials in the US. Another 14% cite quicker and easier regulatory processes outside of the United States. Nearly all of the remaining companies that choose to market first outside of the United States say they do so because of unpredictable 510(k) requirements.
John Linehan, PhD, a professor of bioengineering at Northwestern University and the study’s lead author, surveyed more than 350 professionals from small, medium, and large companies, all actively engaged in medical device development and closely involved in a recent 510(k) submission. His comments to FDA are based on the survey findings and directly compare IOM’s findings about the 510(k) process with survey data on the same topics.
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By Rebekkah Carney, Principal, Kinemedica Market Solutions, LLC
As the keynote speaker at AdvaMed 2011, former President George W. Bush’s speech to the more than 1,000 AdvaMed participants attending the conference’s plenary luncheon on Tuesday was eagerly anticipated. After attending a private luncheon at which he and AdvaMed leadership hosted four soldiers from the Wounded Warrior Project, the 43rd President of the United States launched into his speech and the follow-up interview hosted by James V. Mazzo, President of Abbott Medical Optics and Chairman of the board of AdvaMed.
After expressing appreciation for the attendance of the medical device trade council’s leadership, membership, and conference attendees for their role in healthcare innovation and contribution to the American industry and economy, President Bush described the importance that he had ascribed to effective healthcare systems during his tenure in office.
“Medical technology represents life-changing innovation,” Bush said, “but in order for us to innovate we need hope.” Bush indicated that before the days of healthcare reform, he had worked across party lines to establish effective healthcare policies to improve access to healthcare by the poor, domestically, and globally.
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FDA has released eight new draft proposals in a report titled “Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency’s Compliance and Enforcement Data.”
These draft proposals are focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making.
In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data Web sites (www.epa-echo.gov1 and http://ogesdw.dol.gov2, respectively). At these meetings, EPA and DOL shared their insights to help FDA learn from, and build upon, their experiences.
Like FDA, EPA and DOL recognize that transparency can drive good behavior and promote regulatory compliance.
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New Products
The Unison OS is suitable for use in controlling operating room equipment, intelligent eyewear, and other advanced medical devices for the home, physician's offices, and hospitals. RoweBots Inc., a supplier of tiny embedded Linux-compatible real-time operating systems (RTOS) products, has released Version 5.2 of the operating system, which uses the Xilinx Microblaze softcore technology. The OS provides the key, high-performance software framework required. The ultra-tiny embedded Linux-compatible RTOS opens a broad set of medical, embedded, or imaging applications to Linux- and POSIX-compatible development with extensive connectivity options, data storage, and substantially enhanced performance on the same hardware.
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Clippard Instrument Laboratory announces the launching of its expanded 3D catalog powered by TraceParts. This new phase includes the company’s electronic and control valve miniature pneumatic lines. Clippard Minimatics are used for control, interface, sensing, logic, and actuation functions. The company also provides standard and special products and value added assemblies.
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Ashcroft has engineered its Type 1082 and 1084 test gauges for sustained accuracy and high reliability. Available in 4 ½, 6, and 8 ½ in. diameters, the Type 1082 provides 0.25%FS accuracy in ranges from vacuum through 10,000 psi. An external zero adjuster, temperature compensation, and Monel wetted parts ensure precision and media compatibility. For field calibration, the 3 in. Type 1084 pocket test gauge is the smallest portable master gauge available, covering ranges to 1000 psi with 0.5%FS accuracy.
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