Medical device companies: Report cites challenges, opportunities in new FDA user fee deal
Medical device companies will face new challenges and opportunities under the FDA's new user fee structure, according to a new PricewaterhouseCoopers report.
The FDA's new authority to change the risk classification on a medical device could present a challenge for med-tech companies, according to a new report from PricewaterhouseCoopers that examines how the recently signed user fee deal will affect the life sciences industry.
The FDA user fee deal, signed into law by President Barack Obama in July, more than doubles the user fees medical device companies pay to have the FDA review their products. The med-tech industry and the federal watchdog agency spent months hashing out the terms of their agreement, which ultimately boosted the fees from $295 million to $595 million over 5 years, in exchange for the FDA meeting performance goals.