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FDA/MDUFMA | GPOs | Reimbursement | Gainsharing | Int'l | Sm. Bus. | Patent | Other

2006 FDA/MDUFMA Updates

 

MDMA Sumbits Comments to the FDA on Informed Consent
November 27, 2006- MDMA submitted comments to the Food and Drug Administration (FDA) regarding FDA’s draft guidance entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.” MDMA is supportive of ensuring that FDA eliminates the confusion caused by the existing regulations and that emergency medicine clinical research is advanced so that unconscious patients presented with cardiac arrest, stroke (who are comatose), traumatic brain injury and other life threatening medical conditions receive the best treatment.
To read MDMA’s letter please click here.

 

FDA Releases Report on its Postmarket Initiative
November 9, 2006- The FDA released a report from its Medical Device Postmarket Transformation Initiative. This initiative is an effort by CDRH to take steps to increase its ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products. 
To learn more about the initiative, please click here.

 

FDA Holds Meeting on UDIs
On October 25, the Food and Drug Administration held a meeting on Unique Device Identifiers (UDI) to discuss the issues associated with the development, implementation, and use of a unique device identification system as well as the costs and benefits of a UDI system. MDMA presented brief remarks stating that we would support a universal, globally harmonized voluntary UDI system. We look forward to working with FDA on this important issue and we will be submitting written formal comments on this topic by FDA’s November 9th deadline.
To read MDMA's comment letter, please click here.

MDMA Supports Coalitions to Increase FDA Appropriations
October 25, 2006- Last week MDMA met with the FDA Alliance and the Coalition for a Stronger FDA, which have been formed to address the congressional appropriations shortfall at the Food and Drug Administration (FDA) . Given the importance of the FDA’s mission, safeguarding America’s health, safety and well-being, it is crucial that the FDA receives increased funding and support to better protect the health of our country. These non-partisan, non-profit coalitions are advocating for increases in FDA resources, including: appropriations, information technology, human resources and personnel retention. MDMA looks forward to being an active participant in these groups and ensuring that the FDA has the resources it needs.

FDA Holds Hearing on Informed Consent
October 6, 2006- FDA will be holding a public meeting on October 11th regarding emergency research conducted without informed consent. This issue could significantly impact the future of emergency clinical research.
For more information, please click here.

 

FDA Publishes FY07 User Fees
On August 1, the FDA published the FY07 device user fee rates. The increases reflect the 8.5% increase afforded under MDUFSA. However, MDMA has made it clear to the FDA that these fee increases are unsustainable, and we are working with FDA to reduce the fee amounts should this program continue beyond 2007. Please remember that companies who have annual domestic revenues under $100m are eligible for a reduced fee. However you must complete the FY 2007 Small Business Qualification Certification (Form FDA 3602). This form is provided in FDA's guidance document, FY 2007 MDUFMA Small Business Qualification Worksheet and Certification, available on FDA's Web site.

FDA Issues Draft Guidance on Premarket Approval Applications
On June 19, FDA issued a draft guidance document to assist device manufacturers who are preparing to submit premarket approval applications (PMA). The “Guidance for Industry and Food and Drug Administration Staff: The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” discusses the administrative process for reviewing Quality System (QS) regulation information contained in a PMA and the time involved in each step, as well as how the inspection of a manufacturing facility fits into the approval process.
Click here to view the guidelines.

FDA Announces Medical Device Innovation Initiative
May 30, 2006- The FDA recently launched a new program called the Medical Device Innovation Initiative. The program is intended to help further facilitate bringing new medical devices to patients. According to the agency, the goal of the Initiative is to "promote early interaction between industry and the FDA to optimize reviews times and foster innovation." In addition, the Initiative includes issuing new guidelines to outline the use of adaptive clinical trial designs. "MDMA applauds the FDA’s efforts to encourage more communication among all stakeholders in the device development process to ensure greater transparency and to foster innovation so that patients and caregivers have access to the safest, most effective medical technology as quickly as possible," said Mark B. Leahey, executive director of MDMA.
To learn more about the Initiative and the draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials."

 

FDA Holds MDUFMA Stakeholder Meeting
On May 22, FDA held a MDUFMA Stakeholder meeting in which the agency reported on progress in meeting two of the performance goals that were included in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). FDA said it would meet the goal of 80% 510(k) decisions within 90 days for fiscal year 2007, but would fall well short of the goal to issue approvable decisions on 50% of pre-market approval application (PMA) submissions for 2007 within 180 days. MDMA praised the FDA for its ability to meet the 510(k) performance goals, but expressed disappointment that FDA did not and will not reach the statutorily mandated PMA performance goal. Specifically, MDMA staff articulated that MDUFMA needs some modifications in order to achieve the intent of the program and that for the program to be reauthorized it must include reasonable and rational fees coupled with real enhanced performance in order to generate support from the medical technology industry.

MDMA Supports Nomination of FDA Commissioner
March 15, 2006- MDMA expressed its support for President George W. Bush’s nomination of Andrew von Eschenbach, MD, to serve as commissioner of the Food and Drug Administration.

"We look forward to working with Dr. Von Eschenbach to ensure that patients have access to innovative, safe and effective medical technology as quickly as possible," said Mark B. Leahey, executive director of MDMA.

In addition to his post as head of the National Cancer Institute, von Eschenbach has served as interim head of the FDA since Lester Crawford resigned in September of last year. Von Eschenbach said he plans to step down at NCI. Sen. Mike Enzi (R-WY), chairman of the Senate Health, Education, Labor and Pensions committee, said he planned to hold a confirmation hearing as quickly as possible.

MDMA and FDA Meet to Discuss MDUFMA II
February 3, 2006 - MDMA met with FDA to discuss issues surrounding the Medical Device User Fee and Modernization Act (MDUFMA) reauthorization. Among the topics discussed were enhancing the qualitative and quantitative goals under MDUFMA, more accurately assessing FDA’s resource needs moving forward, and better determining how FDA has utilized user fees to date.
To view a copy of FDA’s presentation please click here.

CDRH Releases PostMarket Transformation Initiative
January 20, 2006- This week, the Centers for Devices and Radiological Health (CDRH) released information regarding its PostMarket Transformation Initiative. The purpose of the initiative is to increase CDRH’s ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products.
For more information please click here.