FDA Medical Device User Fee Rates: Fiscal Year 2019
On Monday, July 30th, FDA released the medical device user fee rates for fiscal year 2019. The total FY 2019 revenue amount, prior to adjustments, is $190,654,875. Medical device user fee rates are updated each fiscal year and must be paid at or before the time of submittal to avoid delays in the review process.
Medical device user fee rates are split up into two categories based on the size of the business submitting the application. The updated rates for FY 2019 are as follows:
| Application Type | Standard Fee for FY 2019 | Small Business Fee for FY 2019 |
| Premarket Application (PMA, BLA, PDP) | $322,147 | $80,537 |
| Premarket Report | $322,147 | $80,537 |
| Efficacy Supplement | $322,147 | $80,537 |
| Panel-track Supplement | $241,610 | $60,403 |
| De Novo Classification Request | $96,644 | $24,161 |
| 180-Day Supplement | $48,322 | $12,081 |
| Real-time Supplement | $22,550 | $5,638 |
| 510(k) Premarket Notification Submission | $10,953 | $2,738 |
| 30-Day Notice | $5,154 | $2,577 |
| 513(g) Request for Classification Information | $4,349 | $2,175 |
| Annual Fee for Periodic Reporting (Class III Device) | $11,275 | $2,819 |
| Annual Establishment Registration Fee | $4,884 | $4,884 |