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.

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