MDMA members discussed the importance of a predictable and transparent 510(k) this week at a public forum held by FDA. The meeting was conducted in order to discuss the ongoing evolution of the 510(k) approval process. MDMA members' comments also focused on ways the FDA could demonstration how proposed changes will improve patient care and promote innovation.
FDA
02/09/2010
The FDA held a hearing regarding the Center for Devices and Radiological Health's (CDRH) response to, and anticipation of, new or evolving scientific knowledge in regulatory decision-making. In recent months, CDRH has formed an internal Task Force on Utilization of New Science in Regulatory Decision-making, whose purpose is to propose systems that will allow CDRH to be "predictably adaptive" to new science, and to identify steps that CDRH can take to ensure its staff is aware of the...
01/20/2010
The Center for Devices and Radiological Health announced today that Jeffrey Shuren, M.D. will be the permanent director of the Agency; Shuren has been the Acting Director since September. “MDMA looks forward to working with Dr. Shuren to ensure that patients have timely access to safe and effective products,” said Mark Leahey, MDMA President and CEO. MDMA will continue to keep its members informed of FDA’s priorities in 2010, including...
01/08/2010
Last week, the Journal of the American Medical Association published a study examining FDA approvals of PMA cardiology products 2000-2007 PMA. The study’s authors attempted to draw a parallel between drug and device studies in terms of the extensiveness and rigor of the clinical trials designed to test safety and effectiveness. However, MDMA President Mark Leahey, commenting in a Los Angeles Times article on the study, stated that it is not...
12/11/2009
Mark Leahey, MDMA President and CEO, was a keynote presenter at the 8th Annual LifeScience Alley conference in Minneapolis on December 9th. Leahey addressed the changing landscape at FDA, which included FDA's new leadership, the future of the 510(k) program, the FDA advisory...
09/17/2009
WASHINGTON, DC, September 17, 2008 – Medical device industry CEOs, experts and government officials will gather for the Medical Device Manufacturers Association (MDMA) Medical Technology Executive Forum: Key Commercialization Issues Impacting the Medical Device Industry on October 15th at the Crowne Plaza in Palo Alto, CA.
This one day interactive forum will provide CEOs and senior medical technology executives with a practical perspective on managing the key issues...
08/27/2009
The FDA recently announced an increase in user-fees for medical device manufacturers. For FY 2010, device manufacturers will pay about 8.5 percent more than FY 2009 for PMA devices. Companies with revenues less than $100 million annually can qualify for a small-business exemption, which MDMA successful advocated for during the inception of the device user-fee program in 2002.
08/10/2009
MDMA submitted comments to the FDA Transparency Task Force, a group created by the FDA to improve transparency at the Agency. MDMA used the opportunity to highlight some of the industry's transparency concerns associated with the panel process for device reviews.
05/18/2009
The United States Senate confirmed Dr. Margaret Hamburg as the 21st Commissioner of the FDA. Hamburg replaces Acting Commissioner Josh Sharfstein, who will now take the role of Deputy Commissioner. Hamburg received widespread support in the Senate and was approved by voice vote.
The Medical Device Manufacturers Association looks forward to working with Commissioner Hamburg to ensure that patients have timely access to innovative medical technologies...
05/13/2009
A Capitol Hill hearing held yesterday examined the Medical Device Safety Act (MDSA) of 2009, a bill that would overturn a 2008 Supreme Court decision Riegel v. Medtronic, which bars common-law claims challenging the safety and effectiveness of PMA approved medical devices. The Medical Device Manufacturers Association has concerns that the MDSA would significantly stifle innovation in the industry and limit patient access to medical technologies.
