How Much Does a 510(k) Submission Cost?

FDA user fees, regulatory consultant costs and review timeline data from 174,000+ real 510(k) submissions.

FDA 510(k) User Fees for FY 2026

A 510(k) submission to the FDA costs a minimum of $26,067 in FDA user fees for FY 2026 ($6,517 for small businesses), plus establishment registration ($11,423) and regulatory consultant preparation. Total costs typically range from $30,000 to $150,000+ depending on device complexity and testing requirements.

The FDA charges a mandatory user fee for every 510(k) submission. The fee must be paid in full before the FDA begins its review - without payment, the submission is placed on "User Fee Hold." Fees apply equally to Traditional, Abbreviated and Special 510(k)s.

For FY 2026 (October 1, 2025 – September 30, 2026), the official FDA 510(k) user fees are:

FDA 510(k) Application Fees - FY 2026

Fee Type Standard Small Business†
510(k) Premarket Notification $26,067 $6,517
Annual Establishment Registration $11,423 Waiver possible‡
De Novo Classification Request $173,782 $43,446
PMA (Premarket Approval) $579,272 $144,818
† Small business fee applies to companies with gross receipts ≤ $100M certified by CDRH's SBD Program. ‡ Registration fee waiver available for companies with gross receipts ≤ $1M demonstrating financial hardship. Source: FDA MDUFA User Fees FY 2026.

FDA 510(k) User Fee History

FDA user fees are updated annually each October under the MDUFA program. The 510(k) fee has increased significantly since MDUFA V took effect in FY 2023:

510(k) User Fee by Fiscal Year

Fiscal Year Standard Fee Small Business
FY 2026 (current) $26,067 $6,517
FY 2025 $24,336 $6,084
FY 2024 $22,248 $5,562
FY 2023 $19,870 $4,967
Source: FDA Federal Register notices. FY 2026 fees apply October 1, 2025 – September 30, 2026. The 510(k) fee increased 31% from FY 2023 to FY 2026 under MDUFA V.

Small Business Fee Qualification

Companies with gross receipts or sales of $100 million or less in their most recent federal income taxable year qualify for the reduced small business fee - a 75% reduction from $26,067 to $6,517. Qualification requires certification through the CDRH Small Business Determination (SBD) Program. Foreign businesses must submit Form FDA 3602A.

Fee Exemptions

No user fee is required when: the 510(k) is reviewed by an FDA-accredited third-party reviewer; the device is intended solely for a pediatric population; or the submitter is a state or federal government entity and the device will not be commercially distributed.

Refunds

The FDA will refund the fee if the submission fails to pass acceptance review (Refuse to Accept) and you choose to withdraw - but will not refund once the submission is accepted for review. A resubmission after withdrawal always requires a new fee.

FDA 510(k) Review Timeline - Real Data from the Dataset

The FDA user fee is only part of the total cost of a 510(k) submission. Review time represents a significant indirect cost - every additional month in review means delayed market entry, continued R&D spend and deferred revenue.

510(k) Review Time - 510k Database Dataset

Metric Days Note
All-time median (cleared) 129d 174,000+ records
Last 2 years avg (cleared) 149d Recent trend
Denied submissions (DENG) 337d +188d vs cleared
Based on FDA 510(k) submissions in the 510k Database dataset. Review time calculated from submission date to FDA decision date. Browse all clearance data →

Review times have increased in recent years - the last 2-year average of 149 days is 15% above the all-time median of 129 days. Plan your regulatory timeline accordingly when budgeting for market entry.

A denied submission (DENG - Not Substantially Equivalent) takes an average of 337 days before receiving a final decision - more than double the cleared average - and requires a new full 510(k) fee if resubmitted. What is a Not Substantially Equivalent determination?

510(k) Regulatory Consultant Costs

The FDA user fee covers only the regulatory review cost. Most manufacturers - especially those without an internal regulatory affairs team - engage a regulatory consulting firm to prepare and manage the 510(k) submission. Consultant fees are not published by the FDA and vary significantly by firm, device complexity and submission type.

The 510k Database dataset includes 383 regulatory consulting firms identified from real FDA 510(k) submission records - ranked by submission volume, specialty and clearance rate. Browse all FDA 510(k) regulatory consultants →

What Influences Consultant Costs

  • Device complexity - Class II devices with extensive performance testing require more preparation time than straightforward predicate comparisons.
  • Submission type - Special 510(k)s (for modifications to your own cleared device) are typically faster and less expensive to prepare than Traditional 510(k)s.
  • FDA panel - Cardiovascular and orthopedic devices face more stringent substantial equivalence review and typically require more regulatory preparation.
  • Predicate strategy - Finding the right predicate device is critical. Weak predicate selection is a leading cause of denial. What is a predicate device?
  • International manufacturers - Non-U.S. companies often require additional support for FDA correspondence, US Agent designation and document formatting.

510(k) Review Time by FDA Panel - Budget Planning Data

Review time varies significantly by FDA specialty panel. Planning your market entry timeline requires understanding the typical review duration for your device category - not just the FDA's 90-day target.

Browse review time data by specialty:

Cardiovascular Orthopedic Radiology Surgery Neurology Dental Anesthesiology General Hospital

Each specialty page includes all-time average, last 2-year average and denied submission average - updated monthly from FDA data.

510(k) Submission Cost by Device Type

The FDA user fee is fixed, but total 510(k) costs vary significantly by device type. The main variable is FDA review time - longer reviews mean higher indirect costs from delayed market entry. The following ranges are based on FDA user fees and real review time data from the 510k Database dataset.

Estimated Total Cost by Submission Complexity

Scenario FDA Fee Typical Review
Special 510(k)
Modification to your own cleared device
$26,067 ~90d
Traditional 510(k) - straightforward predicate
Clear predicate device, standard testing
$26,067 ~129d
Traditional 510(k) - complex device
Cardiovascular, orthopedic or imaging devices
$26,067 ~150-200d
Denied submission + resubmission
NSE determination followed by new submission
$52,134 ~337d + resubmission
Review times based on 510k Database dataset averages. FDA user fee is fixed regardless of review outcome. Use the 510k Database search to identify predicate devices and benchmark review times for your specific device category.

Total 510(k) Submission Cost - What to Budget

A complete 510(k) budget for FY 2026 should account for:

510(k) Cost Components

Cost Component Standard Small Business
FDA 510(k) user fee (FY 2026) $26,067 $6,517
Annual establishment registration $11,423 $11,423
Regulatory consultant preparation Varies by firm Varies by firm
Testing and performance data Device-specific Device-specific
Resubmission fee (if denied) +$26,067 +$6,517
FDA user fees sourced from FDA MDUFA FY 2026 . Consultant and testing costs are not published by the FDA and vary by device type and firm. 510k Database is not affiliated with the FDA.

Frequently Asked Questions

What are the FDA 510(k) user fees for 2026?

For FY 2026 (October 1, 2025 – September 30, 2026), the standard 510(k) user fee is $26,067. Small businesses with gross receipts of $100 million or less pay a reduced fee of $6,517. All three 510(k) types - Traditional, Abbreviated and Special - are subject to the same fee.

Do small businesses get a discount on 510(k) fees?

Yes. Companies with gross receipts or sales of $100 million or less qualify for a 75% reduced fee of $6,517. Qualification requires certification through the CDRH Small Business Determination (SBD) Program. U.S. companies submit Form FDA 3602; foreign companies submit Form FDA 3602A.

How long does FDA 510(k) review take?

Based on 174,000+ submissions in the 510k Database dataset, the all-time median review time for cleared devices is 129 days. The last 2-year average is 149 days, reflecting a recent increase in review times. The FDA's official target is 90 days, but real-world timelines are consistently longer. Denied submissions average 337 days before a final Not Substantially Equivalent determination.

Is the 510(k) fee refundable?

Partially. The FDA will refund the fee if the submission fails acceptance review (Refuse to Accept) and you choose to withdraw. Once a submission is accepted for review, the fee is not refundable - even if you later withdraw it. A resubmission after withdrawal always requires a new full fee.

Is there a fee for a Special 510(k)?

Yes. All three 510(k) types - Traditional, Abbreviated and Special - are subject to the same user fee ($26,067 standard or $6,517 small business for FY 2026). The only fee-exempt 510(k)s are those reviewed by an FDA-accredited third-party reviewer, those for devices intended solely for a pediatric population, or those submitted by government entities for non-commercial devices.

What is the cost of resubmitting after a denial?

A resubmission following a Not Substantially Equivalent (DENG) determination requires paying the full fee again - $26,067 standard or $6,517 small business. In addition, denied submissions average 337 days in review before the final decision, meaning significant additional time and preparation cost before resubmitting. Learn more about NSE determinations →

510k Database is not affiliated with or endorsed by the FDA. Fee information is sourced from the official FDA MDUFA user fee page and is provided for informational purposes only. Always verify current fee amounts directly with the FDA before submitting a 510(k) application. FDA user fees are updated annually each October.