The cost to obtain FDA approval or clearance for a medical device is not a single, fixed fee, but rather depends significantly on the device's classification, risk level, and the specific type of regulatory submission required. These fees are subject to change annually. For 2024, the application fees vary widely, from thousands to hundreds of thousands of dollars, with reduced rates available for qualifying small businesses.
FDA Medical Device Application Fees (2024)
The table below outlines the standard fees and small business fees for various medical device application types to the FDA for the fiscal year 2024:
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| 510(k) Premarket Notification | $21,760 | $5,440 |
| 513(g) Request for Information | $6,528 | $3,264 |
| Premarket Approval (PMA) | $483,560 | $120,890 |
| Product Development Protocol (PDP) | $483,560 | $120,890 |
| Premarket Report (PMR) | $483,560 | $120,890 |
| Biologics License Application (BLA) | $483,560 | $120,890 |
| De Novo Classification Request | $145,068 | $36,267 |
It is crucial for medical device manufacturers to understand which submission type applies to their device, as this directly determines the primary FDA user fee they will incur.
Understanding Different Submission Types
The application fees correspond to different pathways designed for varying device classifications and regulatory requirements:
- 510(k) Premarket Notification: This is the most common submission type for Class II devices. It demonstrates that the new device is substantially equivalent to a legally marketed predicate device that is not subject to Premarket Approval (PMA). This leads to clearance, not approval.
- Premarket Approval (PMA), Product Development Protocol (PDP), Premarket Report (PMR), Biologics License Application (BLA): PMA is the most stringent type of device marketing application required for Class III devices, which are high-risk. These devices typically support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PDP and PMR are alternative pathways for certain Class III devices, while BLA applies to biological products. These submissions lead to approval.
- De Novo Classification Request: This pathway is for novel low-to-moderate risk devices (typically Class I or II) that do not have a predicate device and thus cannot be cleared through the 510(k) process. It establishes a new classification for such devices.
- 513(g) Request for Information: This is a submission used to get a determination from the FDA on the classification and regulatory requirements for a device. While it incurs a fee, it's not a marketing submission itself but rather a preliminary step to gather information.
Factors Beyond Application Fees
It's important to note that these fees cover only the FDA's application processing. The total cost of bringing a medical device to market extends far beyond these direct government fees. Companies must also budget for significant expenses related to:
- Research and Development (R&D): Extensive prototyping, testing, and design validation.
- Clinical Trials: If required, these can be immensely expensive, involving patient recruitment, data collection, and analysis.
- Quality Management System (QMS) Implementation: Developing and maintaining a robust QMS compliant with FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 13485).
- Consulting Services: Hiring regulatory consultants, quality assurance specialists, and legal advisors to navigate complex requirements.
- Manufacturing Costs: Setting up production lines, sourcing materials, and ensuring compliance.
- Post-Market Surveillance: Ongoing monitoring and reporting requirements once the device is on the market.
Therefore, while the FDA application fees provide a concrete starting point, they represent only one component of the overall financial investment required for medical device commercialization.
