The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we conclude negotiations for the next reauthorization of the medical device user fee program.
- Date, Time and Location
- Federal Register Notice
- Proposed Recommendations
- Public Comment
- Contact Us
FDA held this meeting on March 28, 2012 at 9:00am at the following location:
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
The meeting was also webcast.
The Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the medical device user fee program.
The Food and Drug Administration (FDA) is announcing their intent to hold a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Act (MDUFA) for fiscal years (FYs) 2013 through 2017. MDUFA authorizes FDA to collect user fees and use those fees for the process for the review of device applications. The current legislative authority for MDUFA expires on October 1, 2012. New legislation will be required for FDA to collect medical device user fees for future fiscal years.
As required by Section 738A(b)(2), (3), and (6) of the FD&C Act (21 U.S.C. 379j-1(b)(2), (3), and (6)), FDA obtained prior public input and negotiated an agreement with regulated industry while periodically consulting with patient and consumer advocacy groups and made minutes of negotiation and stakeholder meetings publicly available. Section 738A(b)(4) of the FD&C Act (21 U.S.C. 379j-1(b)(4)), requires that, after holding negotiations with regulated industry and before transmitting the Agency’s final recommendations to Congress for the reauthorized program (MDUFA III), FDA do the following: (1) present the draft recommendations to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, (2) publish the draft recommendations in the Federal Register, (3) providea period of 30 days for the public to provide written comments on the draft recommendations, (4) hold a meeting at which the public may present its views on the draft recommendations, and (5) after consideration of public views and comments, revise the draft recommendations as necessary.
FDA and regulated Industry have completed negotiations; FDA now invites public comment on the draft recommendations for the next reauthorized program. After the public meeting and the public comment period, FDA will revise the draft recommendations as necessary. In addition, the Agency will present the draft recommendations to the Congressional committees.
The purpose of the upcoming meeting is to hear stakeholder views on the draft recommendations for the reauthorized program (MDUFA III). The following information is provided to help potential meeting participants better understand the history and evolution of the medical device user fee program and the current status of the MDUFA III draft recommendations.
The proposed recommendations for MDUFA III address many of the priorities and concerns identified by public stakeholders and the device industry, and many of the important challenges identified by FDA. Each recommendation is briefly described in the Federal Register notice with reference to the section of the draft commitment letter where more detailed information can be found. Further description of the proposed goals and commitments can be found in the draft MDUFA III commitment letter.
In conjunction with the proposed enhancements and performance goals outlined in the draft commitment letter, FDA is proposing new user fees and several statutory changes. The specific proposals are briefly described in the Federal Register notice. Further description of the proposed fee structure and proposed statutory changes can be found in the draft MDUFA III legislative language.
|Time||Subject||Name of Speaker|
|9:00 am||Welcome||Peter Beckerman, JD, Senior Policy Advisor, Office of Policy, Office of the Commissioner, FDA|
|9:05 am||Opening Remarks|
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health, FDA
Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, FDA
|9:30 am||FDA Perspective||Malcolm Bertoni, Assistant Commissioner for Planning, FDA|
|10:15 am||Stakeholder Perspectives||Lana Keeton, Founder & President, Truth in Medicine Incorporated |
Kate Ryan, Program Coordinator, National Women’s Health Network
Paul Brown, Government Relations Manager, National Research Center for Women & Families
|11:15 am||Regulated Industry Perspectives|
Janet Trunzo, Executive Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association (AdvaMed)
Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
Elisabeth George, Industry Chair, Technical & Regulatory Committee, Medical Imaging and Technology Alliance (MITA); Vice President Global Government Affairs, Regulations & Standards, Philips Healthcare
Jen Bullard Bowman, MPH, Vice President for Policy and Regulatory Affairs, American Clinical Laboratories Association (ACLA)
|12:00 pm||Open Comment Period|
|12:45 pm||Closing Remarks||Malcolm Bertoni, Assistant Commissioner for Planning, FDA|
Any person may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 http://www.regulations.gov. It is only necessary to send one set of comments. Comments are to be identified with the docket number [Docket No. FDA-2010-N-0389]. Received comments may be seen in the Division of Dockets Management between 9am and 4pm, Monday through Friday. To ensure consideration, all comments must be received by April 16, 2012.
For questions regarding meeting content please contact Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5861, FAX: 301-847-8142, MDUFAReauthorization@fda.hhs.gov