The FDA this week released the 2013 pricing structure for medical device review, including discounted pricing for companies with less than $100 million in annual revenues.
The fees, which represent as substantial increase from rates for 2012, were established in the 3rd iteration of the Medical Device User Fee Act agreed upon by the med-tech industry and the federal watchdog agency.
MDUFA III nearly doubles total user fees for medical device companies from $295 million over 5 years to $595 million – but the industry expects something in return.
"This user fee agreement really isn’t your father’s user fee agreement," industry lobbying group AdvaMed’s CEO Steve Ubl said the day after the Senate approved the final bill. "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."
The FDA agreed to meet certain performance goals and undertake measures to enhance speed and efficiency in product review in exchange for the larger fees. The funding will also allow the agency to hire more than 200 full-time-equivalent workers over the course of the 5 years, according to an FDA notice.
The measure offers discounted rates for companies which qualify as a small business, and firms with less than $30 million in gross sales and receipts may qualify for a waiver for their 1st PMA.
"MDUFA III is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives," according to the agency. "Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market."
The fees for 2013 are as follows (small-business fees in parentheses):
|Panel-track PMA supplements:||$186,000||($46,500)|
|Request for classification:||$3,348||($1,674)|
|PMA annual report:||$8,680||($2,170)|
|Annual establishment registration fee:||$2,575||($2,575)|