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 […]
User fees
FDA user fees set to rise 4% in fiscal 2019
The FDA last week set the user fee rates for fiscal 2019, which is slated to begin in October, raising the fees across the board by nearly 4%. Medical device makers pay user fees to have the FDA review their products. The rates jumped by more than 33%, with the fee for one popular protocol […]
Most FDA user fees set to rise 33%
The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%. All but one of the user fees for fiscal 2018, which begins Oct. 1, are going […]
Trump signs FDA user fee bill into law
President Donald Trump last week signed a bill to re-up the agreement between the FDA and the medical device and pharmaceutical industries, putting medical device companies in line for a collective $1 billion in user fees. Companies pay user fees to help cover the cost of the safety watchdog’s reviews of their products. The bill […]
US House passes medical device user fee agreement
The US House of Representatives today passed a bill to reauthorize the FDA’s medical device user fee program, alongside a prescription drug, generic drug and bio similar programs through 2022. Newly appointed FDA commissioner Scott Gottlieb applauded the passage, saying it was a “timely reauthorization key for FDA, patients,” on Twitter after the bill passed. […]
CBO scores Senate’s FDA user fees bill
The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022. The “FDA Reauthorization Act of 2017” would see medical device companies put […]
Medical device execs find ally in HHS chief Price on medtech tax
The covey of medical device executives that alit on Capitol Hill last week to lobby for repealing the medtech tax and getting a new user fee deal with the FDA in place reportedly found a ready ally in Dr. Tom Price, head of the U.S. Health & Human Services Dept. More than 50 medical device […]
House panel advances user fee bill
A U.S. House panel yesterday advanced the Lower Chamber’s version of the bill to reauthorize the user fee deal between the medical device and drug industries and the FDA. Medical device and drug companies pay user fees to have the FDA review their products. The last Medical Device User Fee Act in 2012 doubled user fees from $295 […]
Senate committee updates FDA user fee bill
The U.S. Senate’s Health, Education, Labor & Pensions Committee this week floated an updated “manager’s amendment” to the House bill reauthorizing the user fee deal between the FDA and the medical device and drug industries. The HELP panel’s amendments, issued ahead of a committee vote slated for tomorrow, include all of the elements hammered out in […]
Senate, House committees float stop-gap user fees bill
Aiming to avoid laying off thousands of workers at the FDA, legislators on Capitol Hill last week floated a bill to reauthorize the user fee agreement between industry and the federal safety watchdog. Medical device and drug companies pay user fees to have the FDA review their products. The last Medical Device User Fee Act in 2012 […]
Trump budget would double FDA user fees
The Trump administration’s proposed budget, released today, would double the user fees medical device companies pay to have the FDA review the safety and efficacy of their products. The budget proposal would set user fees at $2 billion for 2018, about $1 billion more than the fee schedule for this year (annualized to correspond to the calendar year). In […]