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Fee rates and payment instructions for companies submitting new medical device applications to the federal Food and Drug Administration have been released for fiscal year 2019, which began on Oct. 1, 2018.
The fees help the agency make the regulatory process more efficient so that such devices can get approved for use in the U.S. market more quickly, according to the FDA. The fees can change annually based on increases in government payroll costs and inflation.
Companies that qualify as small businesses get reduced rates. To be approved for the reduced rates, a business and its affiliates must have gross sales not exceeding $100 million for the most recent tax year, the FDA reports on its website.
Under the federal Food, Drug and Cosmetics Act, different types of medical device submission fees are determined based on a percentage of the standard charge for a premarket application. Such a premarket submission is defined as a premarket approval application (PMA), product development protocol (PDP) or a biologics license application, or BLA.
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Medical Device User Fees for FY 2019
| Application Fee Type | Standard Fee (% of Standard Fee for Premarket Application) | FY 2019 Standard Fee | FY 2019 Small Business Fee |
| Premarket application | Base fee specified in statute | $322,147 | $80,537 |
| Premarket report | 100 | $322,147 | $80,537 |
| Efficacy supplement (to an approved biologics
license application) | 100 | $322,147 | $80,537 |
| Panel-track supplement | 75 | $241,610 | $60,403 |
| De novo classification request | 30 | $96,644 | $24,161 |
| 180-day supplement | 15 | $48,322 | $12,081 |
| Real-time supplement | 7 | $22,550 | $5,638 |
| Premarket notification submission | 3.4 | $10,953 | $2,738 |
| 30-day notice | 1.6 | $5,154 | $2,577 |
| Request for classification information | 1.35 | $4,349 | $2,175 |
| Annual fee for periodic reporting on a class III device (one that is implanted or presents a potentially high patient risk) | 3.5 | $11,275 | $2,819 |
| Annual establishment registration fee (to be paid
by the establishment engaged in the manufacture, preparation, propagation, compounding or processing of a device) | Base fee specified in statute | $4,884 | $4,884 |
