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 […]
MDUFA
New medical device user fees agreement passes House
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 […]
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 […]
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 […]
FDA: Coronavirus may extend medtech application reviews
The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in […]
FDA seeks comment on next round of user fees
The FDA has scheduled a public meeting for April 7 to discuss the the medical device user fee program that will be in place from 2022 to 2026. The current Medical Device User Fee Amendment (MDUFA IV) expires Sept. 30, 2022. Before Congress can reauthorize the amendment, the FDA must consult with the regulated industry […]