for substantial savings on medical device application fees in FY2019

As I mentioned in a previous post, there is a substantial reduction in the user fees for most types of medical device applications for small businesses. Certified small businesses are also eligible for a fee waiver on their first PMA (including modular PMA, BLA, PDP, or PMR). The FDA issued new guidance on August 1, 2018 which confirms the eligibility criterion for FY2019 as gross receipts or sales NMT $100M USD. However, the gross receipts limit for the first PMA fee waiver remains at $30M USD, so some companies eligible for discounted fees will not be eligible for the first-time fee waiver. Most companies will benefit more from the decrease in overall fees than the one-time fee waiver.

Check my previous post for a list of the 2019 fees to see your potential discounts, which can be as much as $233,073 for a PMA/PDPD/PMR/BLA. Your company must file every fiscal year for certification, and that filing period is short – August 1 -September 30 of 2018 for FY2019. I recommend you prioritize this application now if you plan to file any type of medical device application next year, because the application requirements may take some time to assemble if you have not previously filed for small business qualification, particularly if you don’t already have an FDA Organization ID number. Full instructions are available in the newly released guidance here.

Text Copyright © Katrina Rogers 2018