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.
The concessions made by the medical device industry include giving the FDA the authority to change the risk classifications on medical devices.
"While device manufacturers may gain from changes in information standards, they must also adapt to the FDA’s new autonomy in device classification," according to the report. "Companies should be better prepared to respond in the event of reclassification, which would include maintaining readily-accessible safety documentation."
In addition, the report warned that medical device companies must be prepared to "respond to the new UDI provisions, which could require serialization not only of finished products but also constituent components," the authors wrote. "This may require manufacturers to rethink sourcing and supplier monitoring processes."
The new user fees offer some advantages, according to the PwC report, including the agency’s decision to harmonize FDA requirements with other countries’ regulatory branches and to allow the use of data collected from outside the U.S. in device review applications.
Other changes that work in favor of the medical device industry include changes to the way the FDA asks companies for more information during the pre-market approval process.
"When the FDA requests additional data from a medical device company – such as a notification letter for pre-market approval – it must now request the ‘minimum necessary’ information needed."
AdvaMed, the national industry council for the medical device industry, has repeatedly hailed the new user fee deal as a 3-way win for patients, med-tech makers and the FDA.
"This user fee agreement really isn’t your father’s user fee agreement," AdvaMed president & CEO Stephen Ubl said in June. "There are a number of perks in this user fee agreement. It’s the first user fee agreement to include goals that are focused on total review times, from the first time of submission at the agency to when the agency makes the final decision on a PMA or 510(k). The agreement, for the first time, includes a provision we refer to lovingly as ‘no submission left behind,’ which requires the agency to meet with companies if the agency misses a performance goal."
