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Originally Published MDDI March 2004NEWSTRENDS
March 1, 2004
3 Min Read
Originally Published MDDI March 2004
Both users fees and appropriations are
President Bush has proposed a record increase in appropriations for CDRH, in hopes of strengthening the medical device review process. The fiscal year 2005 proposal totals $216.7 million, an increase of $25.6 million over FY04.
The budget will be augmented by a projected $33.9 million in industry user fees, an increase of $2.3 million over FY04. Both the user-fee program and the CDRH budget increase are part of the terms agreed to in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). It remains to be seen whether Congress will honor the president's request, made January 30, in its entirety.
FDA says that the budget hike will ensure that it meets its performance goals outlined in MDUFMA.
“FDA is committed to reaching all of the performance goals negotiated in MDUFMA through FY08,” said FDA Commissioner Mark B. McClellan, MD, PhD. “The proposed budget increase for the medical device review program, along with the user fees, will enable us to move aggressively to meet those goals. FDA's goal is to provide the most health protection at the least cost for the public by making the review process more efficient. The proposed budget increase will enable FDA to reduce the cumulative review time it requires to approve and clear medical device applications.”
The agency says the proposed increase will also allow it to enhance reviewer training and skill maintenance, invest in laboratory and infrastructure to help with device review and oversight, improve the information technology systems that support the review process, expand small business assistance, recruit subject-matter experts, and conduct pre-approval inspections. The budget and user-fee funds will also allow the agency to continue to improve review performance in areas where fees are collected, and to make “major improvements” in reviewing breakthrough medical technologies and expedited device submissions.
Industry response was mostly positive. “The Bush administration demonstrated its commitment to ensuring patients have timely access to new lifesaving medical technologies,” said Pamela G. Bailey, president of AdvaMed (Washington, DC). “The funding increase will give FDA the resources it needs to thoroughly and efficiently review tomorrow's breakthroughs, getting them into the hands of the patients and physicians who need them.”
The Medical Device Manufacturers Association (MDMA; Washington, D.C.), which has been more critical of MDUFMA and particularly the user-fee program, had a more mixed reaction. “While we are pleased with the budget total for FY05, we are disappointed that it does not cover shortfalls of approximately $30 million for FY03 and FY04,” said Mark Leahey, executive director. “It is a step in the right direction, but it falls well short of the funding levels agreed to in 2002.” Industry is allowed to revisit the agreement if the shortfall is never made up, and Leahey said MDMA would ask for modifications to the agreement if that happens.
FDA's performance goals for MDUFMA include completing 70% of expedited PMA submissions within 300 days, 75% of PMA supplement actions within 180 days, and 75% of 510(k) first actions within 90 days. The agency expects to spend almost $141.1 million on device reviews in FY05.
The agency also announced, in the annual report of the Office of Device Evaluation, that it had decreased review times in FY03 from FY02 levels. Average review time from submission to decision for 510(k)s dropped from 79 days to 76 days. For PMAs it dropped from 364 days to 359 days, and for PMA supplements, it dropped from 105 days to 93.
Copyright ©2004 Medical Device & Diagnostic Industry
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