New medical device user fees agreement passes Congress

[Image from Unsplash]The U.S. Congress today sent a stopgap funding bill to President Joe Biden’s desk that includes the reauthorization of FDA user fees programs through 2027.

“I am delighted to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products activities,” FDA Commissioner Dr. Robert Califf said on Twitter.

He later tweeted: “It means that we will not need to begin the notification process for user fee-funded staff.”

The reauthorization generally maintains the existing fee structure, but it includes a new mechanism where the FDA will be able to increase fees in later years if it meets goals related to timely review of submissions.

Trade group AdvaMed also applauded the passage of the fifth iteration of the Medical Device User Fee Amendment (MDUFA V).

“The bipartisan passage of this historic five-year agreement…

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New medical device user fees agreement passes House

[Image from Unsplash]The U.S. House last night voted 392-28 to pass Medical Device User Fee Amendments that reflect the latest agreement between the FDA and the medtech industry.

The House bill on FDA amendments that passed, sponsored by Rep. Ann Eshoo (D-California), drew from the MDUFA V agreement between the FDA and medical device industry. It reauthorized the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar through the fiscal year 2027. It also required the development of action plans and related reporting to increase the diversity of participants in clinical trials.

Get the full story on our sister site Medical Design & Outsourcing. 

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New medical device user fees agreement passes House

[Photo by Louis Velazquez on Unsplash]

The U.S. House last night voted 392-28 to pass Medical Device User Fee Amendments that reflect the latest agreement between the FDA and the medtech industry.

The House bill on FDA amendments that passed, sponsored by Rep. Ann Eshoo (D-California), drew from the MDUFA V agreement between the FDA and medical device industry. It reauthorized the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar through the fiscal year 2027. It also required the development of action plans and related reporting to increase the diversity of participants in clinical trials.

“We appreciate the bipartisan work of the House of Representatives in advancing this important reauthorization. Medical technology developers and manufacturers depend on timely FDA consideration of devices to serve patients. The MDUFA V agreement includes firsts for greater acc…

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What you need to know about the FDA’s Total Product Life Cycle Advisory Program pilot

An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization.

My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the regulatory agency’s commitment letter. Though the pilot could be modified or scrapped by the FDA after hearing from the public in April or by lawmakers as they consider reauthorizing MDUFA, the letter offers the program’s latest and most detailed outline.

“The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough dev…

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FDA seeks more money, authority in budget request

The FDA wants more money from Congress for the coming fiscal year, and more power, too.

Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).

The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.

Get the full story on our sister site, Medical Design & Outsourcing.

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Fifth round of medtech user fee talks set to begin soon

Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances.

The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de novo requests.

Negotiations on MDUFA V were scheduled for April 2020 but were waylayed by the pandemic. Following an initial stakeholder meeting in October, the FDA now says the virtual monthly meetings may begin in March. Congress must pass by MDUFA V by September 2022, when the current user fee law expires.

Get the full story on our sister site, Medical Design & Outsourcing.

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