The cost for a Pre-market Approval (PMA) application to the FDA varies depending on the applicant's business size, with a standard fee of $483,560 and a small business fee of $120,890.
Understanding Pre-market Approval (PMA) Costs
A Pre-market Approval (PMA) is the most rigorous type of marketing application required by the U.S. Food and Drug Administration (FDA) for Class III medical devices. These devices typically include those that sustain or support human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. The cost primarily refers to the FDA user fee required to submit the application for review.
PMA Application Fees
The FDA collects user fees for certain medical device applications to help fund the review process. These fees are subject to annual adjustments. For a PMA, the fee structure differentiates between standard applicants and qualifying small businesses.
PMA Application Fees for 2024
The following table outlines the FDA user fees for PMA applications:
| Application Type | Standard Fee | Small Business Fee |
|---|---|---|
| PMA | $483,560 | $120,890 |
- Standard Fee: This is the full fee applicable to most applicants.
- Small Business Fee: Eligible small businesses, which meet specific criteria defined by the FDA (typically related to gross receipts and affiliations), can qualify for a significantly reduced fee. This aims to support smaller entities in developing medical technologies.
It's important to understand that these figures represent only the FDA user fee for the application submission itself. They do not encompass the vast array of other significant costs involved in bringing a Class III medical device to market. These additional expenses can include:
- Research and development (R&D)
- Pre-clinical testing
- Extensive clinical trials
- Manufacturing and quality system implementation (e.g., ISO 13485 compliance)
- Regulatory consulting and legal fees
- Post-market surveillance requirements
Collectively, the total investment to develop and commercialize a Class III medical device requiring a PMA can amount to millions of dollars, making the FDA application fee just one component of the overall financial commitment.
