In early August each year, the U.S. Food and Drug Administration (FDA) publishes various user fee rates for the upcoming fiscal year (October 1 to September 30). On August 3, 2015, FDA published its medical device and generic drug user fee rates for fiscal year (FY) 2016.
Medical Device User Fees
FDA has authority to collect medical device user fees under the Medical Device User Fee Amendments (MDUFA). With the exception of the establishment registration fee, medical device user fees are reduced for small businesses. The FY 2016 medical device user fee rates are as follows:
- Establishment Registration Fee : $3,845 (No Reduction for Small Businesses)
- Premarket Application (PMA, BLA, PDP): $261,388 / $65,347 for Small Businesses
- Premarket Notification (510(k)) : $5,228 / $ 2,614 for Small Businesses
- 513(g) request for classification information: $3,529 / $1,765 for Small Businesses
- Annual periodic reporting fee for class III device: $9,149 / $2,287 for Small Businesses
FDA’s FY 2016 medical device user fee rates show an increase from the FY 2015 rates. The most significant increase is found in the standard PMA fee, which increased by over ten thousand dollars.
To be considered for small business recognition for FY 2016, FDA must receive the request from a company, along with tax returns that have been verified by its country’s tax authority. Small business recognition must be requested annually, as it expires on September 30 of each year. Registrar Corp can help medical device companies determine whether or not they qualify as a small business, and if so, can help with the submission of the request. Registrar Corp can also register medical device companies with FDA and review a 510(k) for FDA compliance.
Generic Drug User Fees
Generic drug user fees are authorized under the Generic Drug User Fee Amendments of 2012 (GDUFA). FDA collects both application and facility fees from human generic drug manufacturers. There are no small business fee reductions for generic drugs. The FY 2016 fees are as follows:
- Abbreviated New Drug Application (ANDA): $76,030
- Prior Approval Supplement (PAS) to an ANDA: $38,020
- Drug Master File (DMF): $42,170
- Active Pharmaceutical Ingredient (API)—Domestic: $40,867
- API—Foreign: $55,867
- Finished Dosage Form (FDF)—Domestic: $243,905
- FDF—Foreign: $258,905
The FY 2016 application fees show a significant increase when compared to the FY 2015 rates. Both the ANDA and DMF application fees increased over fifteen thousand dollars. The facility fees are also slightly higher than FY 2015.
Registrar Corp helps medical device and generic drug manufacturers navigate and comply with U.S. FDA regulations. For questions about or assistance with U.S. FDA regulations, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/livehelp.
About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 18 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations
This blog was originally published as a press release.