The U.S. government continues to create a lot of uncertainty for the medical device industry, but medtech companies are still making some big moves. The frenzy of major mergers continues, which makes sense from an investor standpoint when it comes to reducing risk. Meanwhile, companies from outside the industry – including such high-tech giants as Apple, […]
MDUFMA
Should the medical device industry pay user fees to CMS?
Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by […]
FDA, medical device industry strike deal over user fees
The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products. The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning […]
AdvaMed lauds user fee return, new funding for FDA | MassDevice.com On Call
MASSDEVICE ON CALL — Medtech industry lobbying group AdvaMed offered high praise for the federal government’s 2014 omnibus appropriations legislation, which restored important funding for the FDA.
The bill returned to the agency about $85 million in collected user fees that had been locked away due to the federal sequester, funds that medical device and drug companies pay for applications for FDA review.
FDA needs more consistency in medtech reviews, consultants say
The FDA needs to make some quality and consistency improvements to meet the promises it made during the latest round of medtech user fee negotiations, according to a team of Booz Allen Hamilton consultants evaluating the FDA’s medical device regulatory review program.
FDA meeting sacrificed to government shutdown
Medical device makers will have to wait a little longer for progress on implementation of the FDA’s Safety & Innovation Act, now that a meeting with a Senate Health, Education, Labor & Pensions committee has been canceled amid the federal government shutdown.
FDA proposes fiscal 2014 user fee rates
The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2% across the board.
The FDA’s Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren.
The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.
Pryor introduces Senate bill shielding FDA user fees from sequestration
Sen. Mark Pryor (D-Ark.) has introduced a bi-partisan bill to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration.
In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new devices and drugs.
Congress: House bill seeks to shield user fees from sequester with FDA S.O.S bill
Lawmakers on Capitol Hill have floated a proposal to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration.
In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new devices and drugs.
Can the FDA keep its user fee promises amid sequester?
The federal sequester is siphoning away part of the funds that the medical device industry is paying for FDA review of new technologies, and that means the agency may not be able to keep all the promises it made in exchange for hiking its user fees.
U.S. FDA guidance explains user fees for medical device reviews
By Stewart Eisenhart, Emergo Group
