Upcoming Medical Device User Fees Unveiled
The schedule of fees medical device manufacturers and sponsors will be required to pay under the Medical Device User Fee Act (MDUFA)-part of the recently passed Food and Drug Administration Safety and Innovation Act (FDASIA)-was released on 30 July by US regulators.
The fees apply only to the fiscal year between 1 October 2012 and 30 September 2013, after which time an inflation-adjusted set of fees are set to come into effect.
The base fee for a premarket application (PMA) in 2012-2013 will be $248,000, and establishment registration fees are set at $2,575.
Nearly all fees are based on the PMA fee, US regulators explained. Panel-track supplements, for example, are required to pay 75% of the standard PMA fee, while a 510(k) premarket notification pays just 2% ($4,960) of the standard PMA fee.
Other fees include:
- for a panel-track supplement, 75 percent of the standard fee
- for a 180-day supplement, 15 percent of the standard fee
- for a real-time supplement, 7 percent of the standard fee
- for a 30-day notice, 1.6 percent of the standard fee
- for a 510(k) premarket notification, 2 percent of the standard fee
- for a 513(g) request for classification information, 1.35 percent of the standard fee
- for an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee
Small Business Waivers Available
Small businesses will be eligible for fee reductions under the MDUFA legislation if they make less than $100 million in sales each year, and FDA notes similar waivers are available for "qualified applicants" whose devices fall under a subjective designation of being "in the interest of public health." Additional waivers are available for first-time submitters of PMA's, Product Development Protocols or Biologics License Applications if the company has gross sales receipts of less than $30 million.
"For all submissions other than a 510(k) premarket notification, a 30-day notice, and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission," FDA explains. "For a 510(k) premarket notification submission, a 30-day notice, and a 513(g) request for classification information, the small business fee is 50 percent of the standard (full) fee for the submission."
A small business would, in other words, pay $62,000 for a PMA, $2,480 for a 510(k), $1,980 for a 30-day notice and $1,674 for a 513(g) request for classification information. Some fees, such as facility registration fees, are not eligible for a fee reduction.
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