The FDA finalized and released their new Guidance For Industry for the 510(k) Third Party Review Program on March 12.
FDA’s Third Party 510(k) (3P510k) Review Program, formerly known as the Accredited Persons Program, allows device manufacturers to submit 510(k) applications for eligible devices to a Third Party Reviewer, who uses FDA criteria to evaluate the submission. Per the FDA, about 50% of the 510(k) submissions the agency receives are eligible for the Third Party Review Program.
Here are answers to some of the most common questions related to this update.
How does this change the 510(k) clearance process?
Under the Third Party Review Program, a 510(k) submission for an eligible device may first be submitted to an accredited 3P510k Review Organization rather than directly to the FDA. The use of this program by device manufacturers is voluntary and as with any 510(k) application, the submitter needs to show substantial equivalence to a legally marketed device.
Why were new guidelines put in place?
Per the document, the objectives of the guidance are:
- To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations
- To outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k Review Organizations
- To ensure consistent quality of work among 3P510k Review Organizations to eliminate the need for routine, substantive re-review by FDA.
The 3P510k Review Program is intended to enable the FDA to focus its internal review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate-risk and less complex devices by 3P510k Review Organizations, and to provide manufacturers of eligible devices a voluntary alternative review process that may result in faster determinations on 510(k) applications.
Which devices are eligible for review through the Third Party Review Program?
The guidance document lists the factors used in determining device type eligibility to be considered for the program and FDA maintains a List of Devices Eligible for Third Party Review. Some of the factors listed include:
- Device classification - Only Class I and II devices are eligible for review. Class III devices are not eligible for the 3P510k review program.
- Whether the device type is implantable, life sustaining, life supporting, and well understood
- Whether the device type is complex and requires interdisciplinary expertise to review
What are the Third Party Review Organization’s responsibilities?
The guidance document outlines the requirements for a Third Party Organization to be recognized by FDA as well as the requirements of how they will complete and document the review process. They should be impartial and free from any conflicts of interest as a criteria to be eligible to conduct 510(k) reviews. Third parties cannot be owned by a manufacturer, supplier or vendor and cannot help design, manufacture, sell or market devices.
Before starting the review of any 510(k) application, the third party will first determine if they have the expertise to review the device type and if the device being submitted is eligible for third party review. They will complete their review and send their recommendation, the complete application and all correspondence with the submitter to the FDA for FDA review and final determination.
What have the critics had to say?
The FDA released the draft of this guidance for comments in September 2018. The FDA responses to the comments were released prior to the final guidance. Comments suggested that the 3P510k Review Program places a greater burden on doctors and patients to research the safety of devices and that the FDA has not demonstrated how the program will protect patients from potentially harmful devices as they are giving up oversight of all device applications.
The FDA responded that they disagreed with these comments as the FDA requires accreditation of the persons reviewing reports and all devices subject 510(k) requirements, whether cleared through the 3P510k program or not, must demonstrate substantial equivalence to a legally marketed device. It is required that the Third Party Reviewer provide a review equivalent to the review that would be performed by an FDA reviewer and FDA still makes the final determination of the clearance.
Do you think that this review process limits FDA oversight and introduces the possibility of patient safety issues? Share your thoughts in the comments.