WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the tentative agreement between FDA and industry negotiators on medical device user fees:
“The ultimate goal for all parties in the user fee negotiations is to make the necessary improvements to the device review program that will ensure patients have timely access to safe and effective products. MDMA is pleased that these...
FDA
02/01/2012
01/02/2012
FDA issued numerous draft guidances over the past two weeks addressing various aspects of its proposed action plan. They included:
- 510(k) Paradigm Draft Guidance
- Product Code Draft Guidance
- Draft Guidance on Appeals
- HUD Draft Guidance
MDMA is currently examining these guidances, and will have a more extensive discussion of their possible impact and what comments should be included for FDA to review on the next FDA Working Group call.
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12/07/2011
Senators Scott Brown (MA) and Kelly Ayotte (NH) introduced legislation this week to improve the de novo process for medical technology innovators, and to increase predictability in the regulatory environment.
"This legislation would cut red tape for innovators and allow new products to reach patients faster," Senator Brown said. "The United States leads the global medical device industry, and in order to stay on top and keep jobs in America, we have to make sure...
11/15/2011
A new piece of legislation was introduced in the Senate this week to help speed up the approval and clearance of medical devices. The legislation, "Patient Access to Medical Innovation Act", was introduced by Senator Al Franken (MN), who noted "My legislation would remove unnecessary barriers so that these critical medical devices get to the patients that need them as quickly and safely as possible."
The bill already has bipartisan support, and follows other...
11/10/2011
FDA released new guidance today to address investigational medical device studies in humans.
The draft guidance, "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations" is designed to clarify the FDA's process for approving clinical trials of medical devices. It includes information regarding:
- When the FDA might allow patients to enroll in a study while issues are resolved, an approach called "approval with conditions."
- When...
11/08/2011
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:
- Recognize and correct the disparity between "FDA...
10/28/2011
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...
10/07/2011
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...
10/03/2011
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...
09/30/2011
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...
