FDA Special 510(k) Program Application Requirements and Review Points

About the Special 510(k) Program

The special 510(k) program is an optional fast-track approval path provided by the FDA for specific medical devices for manufacturers to make modifications to their own approved devices.

Prior to the special 510(k) program, manufacturers that modify or update their own medical devices must first submit a new 510(k) application. To simplify the review process, the FDA introduced a special 510(k) process in 1998 to allow rapid approval of changes that do not affect the intended use of the device or that do not alter the basic science and technology of the device.

In 2019, the FDA issued final guidance for the special 510(k) process, significantly expanding the criteria for acceptance of devices and modifications by allowing certain intended uses and technical changes to be reviewed through the special 510(k) process if accompanied by validated methods.

Special 510(k) standards

According to FDA guidance, a device that is eligible for the special 510(k) program must meet three essential requirements:

• Modifications are submitted by manufacturers with legal authority to sell existing equipment.
• Performance data is not needed, or if it is, there must be a validated way to evaluate the change.
• All necessary performance data can be reviewed in the form of a summary or risk analysis.

The special 510(k), like the traditional 510(k), requires the same demonstration of safety and efficacy as a comparable device. The special 510(k) program differs in that the device used for comparison is the manufacturer's own original device.

How Does FDA Evaluate Device Modifications?

In response to rapid changes in the medical device industry, the FDA has adjusted its guidance on special 510(k) programs to more efficiently review device modifications. The FDA has focused its review on two areas:

• The methods used to assess device modifications were validated
• Modify whether the results can be clearly presented in summary or risk analysis form

In reviewing a special 510(k) application, FDA always highlights four key issues:

1. Is it a change to the manufacturer's own device?

The FDA must first confirm that the device is a "legally marketed device owned by the submitter." Any modified devices submitted by other parties will be rescheduled to the traditional 510(k) path. If the device is submitted under a different name, the FDA will require the submitter to provide documentation that it has the legal authority to sell it.

2. Is performance data needed to evaluate modifications?

If the manufacturer follows design control programs and no additional validation or confirmation tests are required to evaluate a modification, the modification can be submitted as a special 510(k) with clear reasons to justify the absence of performance data.

3. Is there a validated way to evaluate modifications?

A validated method refers to an evaluation method that has been established and validated through scientific principles. The FDA considers the following approaches to be considered validated:

• Supporting methods, protocols, and acceptance criteria used by the submitter in a previously approved 510(k) can be applied to a current 510(k);
• Methods found in FDA-recognized voluntary consensus standards or FDA guidance documents;
• Certified Medical Device Development Tools (MDDT);
• Accepted methods have been widely accepted in the public domain, published in the scientific literature, or through the submitter's own 510(k) approval, grant of a De Novo classification request, or PMA approval.

4. Can data be reviewed by summary or risk analysis?

The FDA emphasizes the significance of risk analysis in special 510(k). The manufacturer should clearly describe the potential risks that may arise from equipment modifications and the risk mitigation measures taken.

For details about the special 510(k) program: FDA Special 510(k) Program

Special 510(k) VS Traditional 510(k)

The special 510(k) program is simpler and more efficient than the traditional 510(k) program. However, the special 510(k) program is not subject to fee waivers, has a similar regulatory burden as traditional 510(k) programs, and can become more complex when dealing with software and medical software devices (SAMDs). In addition, paper traceability records and tracking documents may not be as effective as a digital approach and may affect the accuracy of management.

Overall, the special 510(k) program provides medical device manufacturers with an efficient and convenient path to market access. Proregulations specializes in providing efficient 510(k) application services for the medical device industry, including both traditional 510(k) and special 510(k). Our goal is to help our customers take advantage of the special 510(k) program to shorten time to market and improve product competitiveness in the rapidly evolving healthcare industry. If you are interested in our services or need more details, please contact us.