Third Party (TP) Review Program for medical devices

The Third Party Review (TPR) Program is a voluntary program that allows qualified third-party organizations to review and provide recommendations on medical device submissions to the FDA. This program was established to improve the efficiency of the review process and to provide additional resources for the agency. It is important for medical device manufacturers to understand the TPR program and how it works. As it can offer several benefits for getting their devices to market quickly.

What is the Third Party Review Program?

The Third Party Review Program is a program that enables third-party organizations to review and provide feedback on premarket submissions for medical devices. This program allows manufacturers to use the services of qualified third-party reviewers who have been accredited by the FDA to assess certain types of devices.

How does the TPR Program work?

Under the TPR program, a manufacturer can choose to have their submission reviewed by an accredited third-party reviewer, rather than solely by the FDA. The third-party reviewer assesses the submission against the same standards as the FDA and provides a recommendation to the agency. The FDA then evaluates the recommendation and makes a final determination regarding the submission.

Who is eligible for the TPR Program?

Manufacturers who wish to participate in the TPR program must first select an accredited third-party reviewer to perform the review. The reviewer must be accredited by the FDA to review the type of device being submitted. Manufacturers can check the FDA’s website to find a list of accredited reviewers.

What are the benefits of the TPR Program?

The TPR program offers several benefits for manufacturers seeking to get their medical devices to market quickly. One of the primary benefits is a faster review process. Since the third-party reviewer is responsible for the initial review, the FDA can focus its resources on reviewing more complex submissions. Additionally, the program can provide manufacturers with valuable feedback and recommendations from experienced reviewers, which can help improve the quality of their submissions.

What types of devices are eligible for TPR?

The TPR program is currently available for certain types of medical devices. These include devices that are at moderate risk, such as diagnostic imaging devices and home-use blood glucose monitors. The program is not currently available for high-risk devices, such as implantable devices or life-supporting devices.

  • TPR program is limiting to certain types of moderate-risk medical devices.
  • Diagnostic imaging devices and home-use blood glucose monitors are also in listing.
  • High-risk devices like implantable or life-supporting devices are not eligible.
  • The program may be expanded to include additional types of medical devices in the future.
  • Eligibility criteria may be as per the program continues to evolve.

Challenges and risks associated

While the TPR program offers several benefits, there are also some challenges and risks associated with the program. One potential risk is that third-party reviewers may not always have the same level of expertise and knowledge as FDA reviewers. This could result in inconsistent reviews and recommendations. Additionally, there is a risk that manufacturers may choose to use unaccredited third-party reviewers, which could lead to low-quality reviews and recommendations.

How to ensure a successful TPR submission?

To ensure a successful TPR submission, manufacturers have to carefully select an accrediting third-party reviewer with expertise in the specific type of device. They should also provide a complete and accurate submission, including all necessary documentation and data. By following these steps and working closely with the third-party reviewer, manufacturers can increase their chances of a successful submission and faster review process.

Conclusion

The Third Party Review Program is a valuable tool for medical device manufacturers seeking to get their devices to market quickly. While there are some challenges and risks associated with the program. Careful selection of an accredited third-party reviewer and a complete submission can help ensure success. As the TPR program continues to evolve. It will be important for manufacturers to stay up to date with any changes or updates to the program.