Everyone,
This is a very important regulatory update:
U.S. FDA Medical Device Update
US Food and Drug Administration medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications will increase by about six percent for the agency’s 2020 fiscal year.
FDA’s 2020 user fee schedule takes effect October 1, 2019, and entails six-percent increases for both standard and small-business rates. The agency’s 2020 fiscal year increases are slightly higher than for 2019, which saw four-percent increases for most user fees.
Manufacturers have until September 30, 2019 to submit premarket applications to FDA and pay lower 2019 user fees.
Standard 2020 FDA medical device user fees
| Application Type | FYE 2020 Fee (USD) | FYE 2019 Fee (USD) |
| 510(k) | 11,594 | 10,953 |
| 513(g) | 4,603 | 4,349 |
| PMA | 340,995 | 322,147 |
| De Novo classification request | 102,299 | 96,644 |
| Panel-track supplement | 255,747 | 241,610 |
| 180-day supplement | 51,149 | 48,322 |
| Real-time supplement | 23,870 | 22,550 |
| PMA annual report | 11,935 | 11,275 |
| 30-day notice | 5,466 | 5,154 |
Small business 2020 FDA medical device user fees
| Application Type | FYE 2020 Fee (USD) | FYE 2019 Fee (USD) |
| 510(k) | 2,899 | 2,738 |
| 513(g) | 2,302 | 2,175 |
| PMA | 85,249 | 80,537 |
| De Novo classification request | 25,575 | 24,161 |
| Panel-track supplement | 63,937 | 60,403 |
| 180-day supplement | 12,787 | 12,081 |
| Real-time supplement | 5,968 | 5,638 |
| PMA annual report | 2,984 | 2,819 |
| 30-day notice | 2,728 | 2,577 |
Small-business medical device user fees
To qualify for substantially reduced user fees under FDA’s Small Business Program, manufacturers must have sales of less than $100 million for the most recent tax year.
2020 Establishment Registration fees up seven percent
FDA Establishment Registration fees, applicable to manufacturers that produce all or parts of their devices within the US, or that conduct sterilization and other processing within the US, will increase by seven percent to $5,236 for the 2020 fiscal year. No small-business discounts are available for this fee.
