The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft.
BLAs subject to user fees include original BLAs and BLA efficacy supplements. If an applicant requests withdrawal of an original BLA or efficacy supplement “at any time after FDA has taken its first action, regardless of when the action is taken, FDA will not refund any portion of the user fee,” the guidance states. But if the applicant requests withdrawal of an original BLA or efficacy supplement before FDA makes the filing decision, the agency will refund 75 percent of the fee.
PMA applications subject to user fees include original and modular PMAs, premarket reports, licensing agreement PMAs, panel-track, 180-day and real-time supplements, 30-day notices and periodic reports. The FDA will not refund any portion of the user fee on an original PMA or panel-track supplement after the agency has taken its first action, regardless of when the action is taken.
The guidance also notes that an exemption for PMAs or BLAs intended solely for a pediatric population. The agency may, in certain curses, determine upon review of the device and its intended population, that the application qualifies for this exemption even though the applicant did not request a waiver.
Applicants are subject to the full user fee for traditional BLAs or PMAs if the applicant proposes usage conditions for adult populations after an original or modular PMA or BLA is approved for pediatric use.
The guidance also outlines certain PMA supplements that are not subject to user fees, including special PMA supplements, PMA supplements for manufacturing/sterilization site changes, supplements for trade name changes or post-approval study protocol, and post-approval study labeling updates.
In the case of modular PMAs, applicants must pay the full fee for an original PMA when submitting the first module. On receiving the last module, the modular PMA is converted to an original PMA review track, at which point the filing review for the PMA begins.
In cases where the first module was received between October 1, 2002 and September 30, 2007, the FDA will issue 75 percent refunds of the user fees for those withdrawn prior to the FDA’s filing decision.
Those withdrawn after the filing decision are ineligible for refunds.
Read the final guidance here: www.fdanews.com/12-14-18-UserFees.pdf. — Zack Budryk