By Jamie K. Wolszon –
FDA published in the July 31, 2012 Federal Register a notice announcing the Fiscal Year (“FY”) 2013 rates pursuant to the third iteration of the Medical Device User Fee Act (“MDUFA III”), which was recently enacted as part of the FDA Safety and Innovation Act (“FDASIA”), Pub. L. No. 112-144, 126 Stat. 993 (2012) (see our summary). The notice includes the fee for establishment registrations, which FDASIA broadened to include many more establishments than in the past.
The device user fee schedule establishes the Premarket Approval (“PMA”) Application fee as the baseline fee, with other fees tied to that fee. For instance, MDUFA III sets 510(k) fee amounts at 2% of PMA fees. The fee for a PMA in FY 2013 will be $248,000. This baseline also applies to BLAs (for devices regulated by CBER), Product Development Protocols (“PDPs”) (which are essentially never submitted), a premarket report (seeking permission from FDA to market a reprocessed version of a class III single-use device) and a BLA efficacy supplement.
The notice also sets out the fees for PMA supplements, notices, and reporting. The fee for a panel-track supplement will be $186,000. The fee for a 180-day supplement will be $37,200. The fee for a real-time supplement will be $17,360. The fee for a 30-day notice will be $3,968. The annual fee for periodic reporting on a class III device will be $8,680.
The fee for a 510(k) premarket notification submission will be $4,960, while the fee for a 513(g) request for classification information will be $3,348.
The fee for annual establishment registration is $2,575. FDASIA significantly expanded the scope of establishments subject to the annual establishment registration. Prior to enactment of MDUFMA III, only three types of establishments were subject to registration fees: (1) manufacturers; (2) single-use device reprocessors; and (3) specifications developers. MDUFA III broadened the fee to apply to any establishment that is “engaged in the manufacture, preparation, propagation, compounding, or processing of a device.”
The fees are outlined in Table 1 of the Federal Register notice, and go into effect on October 1, 2012. They are generally modest increases to the fees for FY 2012.
MDUFA III also includes a provision permitting FDA to waive medical device fees, or reduce applicable fees, if it is in the interest of public health. The Federal Register notice does not discuss how FDA intends to apply that new discretion. On the drug side, FDA has published a guidance that discusses, among other waivers and reductions, waivers and reductions to prescription human drug user fees necessary to protect the public health.