Aug 5, 2019

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

 

Qualifying for 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.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA 510(k) premarket notification consulting for medical device and IVD companies
  • FDA medical device classification consulting
  • FDA medical device Establishment Registration and FURLS database listing support
  • Video overview: Introduction to the US FDA medical device registration system
  • Process chart: US FDA regulatory requirements for medical devices
  • Whitepaper: US FDA 510(k) submissions for medical devices