USFDA user fees for Medical Devices
FDA charges a particular fee for medical device product review as per federal law. The fee is applicable for various categories of submissions. The appropriate user fees must be paid by the applicant in order for FDA to initiate the review process, unless the applicant is qualified for a waiver or exemption.
Payment:
Full payment must be paid to FDA at the time or before the date of application. FDA will begin the review once the payment is received; if not then the FDA considers the application incomplete.
User fees for FY 2023
When the user fee is compared with the previous year, there is an increase of about 56% in 510(k). Whereas, about 18% increase were observed in De novo and PMA submissions. The below mentioned fee is effective form October 1, 2022. It is important to note that, FDA is switching to five year user fee program, which implies that the fees mentioned will be effective till September 30, 2027.
Annual Establishment Registration Fee is $6,493. There are no waivers or reductions in the establishment registration fee for small establishments, businesses, or groups.
| Application Type | Standard Fee | Small Business Fee* |
| 510(k) | $19,870 | $4,967 |
| 513(g) | $5,961 | $2,980 |
| PMA, PDP, PMR, BLA | $441,547 | $110,387 |
| De Novo Classification Request | $132,464 | $33,116 |
| Panel-track Supplement | $353,238 | $88,309 |
| 180-Day Supplement | $66,232 | $16,558 |
| Real-Time Supplement | $30,908 | $7,727 |
| 30-Day Notice | $7,065 | $3,532 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $15,454 | $3,864 |
* Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.
