Overview:
As per the Medical Device User Fee and Modernization Act (MDUFMA IV) of 2017, the Food and Drug Administration has updated the lists of Medical Device User Fees for Fiscal year 2021. This comes in effect from 1st October 2021 and includes raising costs of 7% for Premarket submissions including PMA, 510(k) and De Novo requests and IVDs, it rises by 6%.
Establishment registration increases from $5,236 to $5,5467 for standard and small businesses.
Standard FDA Medical Device user fees
Application Type | FYE 2020 (USD) | FYE 2021 (USD) |
| 510 (k) | 11,594 | 12,432 |
| 513 (g) | 4,603 | 4,936 |
| PMA | 340,995 | 365,657 |
| De Novo | 102,299 | 109,697 |
| Panel-track Supplement | 255,747 | 274,243 |
| 180-Day Supplement | 51,149 | 54,849 |
| Real-time supplement | 23,8970 | 25,596 |
| PMA Annual Report | 11,935 | 12,798 |
| 30 Day notice | 5,466 | 5,851 |
Small Business program
Under the CDRH’s Small Program Business Program, small businesses (that is, manufacturers having the gross receipt of $100 million or less), FDA revises the MDUFMA-IV with an increase of 7% in the fiscal year 2021.
Application Type | FYE 2020 (USD) | FYE 2021 (USD) |
| 510 (k) | 2,899 | 3,108 |
| 513 (g) | 2,302 | 2,468 |
| PMA | 85,249 | 91,414 |
| De Novo | 25,575 | 27,424 |
| Panel-track supplement | 63,937 | 68,561 |
| 180-day supplement | 12,787 | 13,712 |
| Real-time supplement | 5,968 | 6,399 |
| PMA Annual Report | 2,984 | 3,200 |
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at info@globalregulatorypartners.com
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More Resources:
2018 FDA Small-Business Medical Device User Fees