Today, the U.S. Food & Drug Administration (FDA) published its User Fees for Fiscal Year 2019 (October 1, 2018 – September 30, 2019), which includes pricing for device submissions and establishment registrations. The official notice from the FDA may be found by clicking here.
The most significant changes for U.S. medical device manufacturers to consider are as follows:
- The Standard and Small Business fees for 510(k) applications will increase to $10,953 and $2,738, respectively.
- This is an increase of $387 and $96 over FY18.
- The Standard and Small Business fees for De Novo Classification Requests, often referred to as De Novo 510(k)s, will increase to $96,644 and $24,161, respectively.
- This is an increase of $3,415 and $854 over FY18.
- Annual Establishment Registration fees will increase to 4,884, which is $260 more than FY18.
Provided below is a total summary of the new FY19 as compared to FY18.
| Submission/Fee Type | 2019 Fee | Current (2018) Fee | Increase | ||
| Standard | Small Business* | Standard | Small Business | Regular/Small Business | |
| Premarket Approval Application (PMA, BLA) or 515(c)(2) Premarket Report** | 322,147 | 80,537 | 310,764 | 77,691 | 11,373 / 2,846 |
| BLA Efficacy Supplement | 322,147 | 80,537 | 310,764 | 77,691 | 11,373 / 2,846 |
| PMA Panel Track Supplement | 241,610 | 60,403 | 233,073 | 58,268 | 8,537 / 2,135 |
| PMA 180-day Supplement | 48,432 | 12,081 | 46,615 | 11,654 | 1,817 / 427 |
| PMA 30-Day Notice | 5,154 | 2,577 | 4,972 | 2,486 | 182 / 91 |
| PMA Annual Report Fee | 11,275 | 2,819 | 10,877 | 2,719 | 398 / 100 |
| De Novo Classification Request | 96,644 | 24,161 | 93,229 | 23,307 | 3,415 / 854 |
| 510(k) | 10,953 | 2,738 | 10,566 | 2,642 | 387 / 96 |
| 513(g) Request for Classification Information | 4,349 | 2,175 | 4,195 | 2,098 | 154 / 77 |
| Annual Establishment Registration Fee | 4,884 | 4,884 | 4,624 | 4,624 | 260 / 260 |
*Companies (and their affiliates) that have gross sales or receipts of ≤100 million dollars in the most recent tax year may qualify for the Small Business Fee. Companies must apply each year for Small Business designation.
** Companies (and their affiliates) that have gross sales or receipts of ≤30 million dollars in the most recent tax year may qualify to have the fee waived for their 1st PMA/BLA.
How can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving reimbursement requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines (read our most recent case study here).
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: communications@namsa.com or 1-419-666-9455. You may also visit our regulatory consulting webpage here.
Barbara Atzenhoefer
Barb has over 25 years’ experience within the medical device industry, holding various executive and management positions in regulatory, clinical affairs and quality systems. She has authored over 70 FDA submissions, conducted 40+ international product marketing and registration applications, and developed nearly 45 global regulatory assessments and strategies. Barb currently serves as Principal Medical Research Scientist (Regulatory) at NAMSA.