A bipartisan, bicameral letter was sent to FDA Commissioner Margaret Hamburg recently urging her to improve the agency's handling of medical technologies.
"Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system," stated the letter.
The signers are asking FDA to:
FDA is hosting a webinar to present a CDRH initiative demonstrating how device manufacturers benefit from well-integrated, best-quality manufacturing practices on Monday, October 31 at 1:00 PM. FDA senior staff will describe the barriers that device manufacturers face in adopting quality manufacturing practices, as well as steps that FDA and industry can take to overcome these barriers. Joining FDA will be industry representatives to discuss CDRH's initiative and to describe how their...
Capturing what many medical technology innovators have been noting for years, a new survey shows the impact that regulatory challenges are having on investments with medical devices.
The report, "Vital Signs: The Threat to Investment in U.S. Medical Innovation and the Imperative of FDA Reform," detailed how medical technology is in danger of losing its primary source of funding, causing serious harm to both U.S. patients and the national economy.
"This...
FDA recently issued its draft guidance for de novo review, a long awaited document that many hope will improve the current pathway.
"MDMA is carefully reviewing the draft guidance on de novo classification, and it is our hope that it establishes a timely and predictable process that will enhance patient care and promote innovation," said Mark Leahey, President and CEO of MDMA. "In order for the final guidance to be successful, it must streamline...
MDMA submitted comments to the 510(k) report that the Institute of Medicine (IOM) issued over the summer. MDMA continues to point out that the current regulatory process has a tremendous track record on ensuring patient safety, and that the IOM's recommendation to eliminate the 510(k) program is misguided.
"Based upon the findings from the IOM that there was no public health crisis associated with the current premarket review process and that the Committee was not able...
A new report by the Milken Institute described the challenges facing America's medical technology and other innovative industries. The report, "The Global Biomedical Industry: Preserving U.S. Leadership," lays out what other countries are doing to invest in future growth and innovation, and provides some suggestions on how the United State can retain its leadership role in the life sciences.
Suggestions include:
The House Energy and Commerce Committee held a forum in Washington, DC this week on innovation and the impact FDA is having on medical technology entrepreneurs.The event is the first in a series of discussions to examine how Congress can help improve the regulatory environment, and enact legislation that will spur job creation.
Executives in the medical device industry addressed the rising challenges facing this dynamic industry, as well as the impact the medical...
FDA released several guidance documents this week as a part of its ongoing efforts to provide current information for innovators.
One guidance document detailed FDA's process of making benefit-risk determinations when assessing premarket applications for medical devices for reasonable assurance of safety and effectiveness.
The guidance highlighted the need to address a device's risks, the manufacturer's ability to mitigate those risks, the benefits of...
WASHINGTON, DC – MDMA President and CEO Mark Leahey issued the following statement regarding the Institute of Medicine’s (IOM) report on the “Public Health Effectiveness of the FDA 510(k) Clearance Process:”
"MDMA will continue to closely examine this report, though we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it. While we are pleased that the IOM recognizes the crucial role medical devices have in health care, it is also...
