Third-Party Review of 510(k)s

FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, 510(k) submitters can voluntarily send their 510(k) to recognized organizations (“3PROs”) for review. This article provides an overview of the 3P program and recent updates that affect 3PROs and 510(k) submitters.

The Third-Party Review Program was conceived to help FDA focus resources on review of higher-risk and more complex device types. FDA retains the authority to make the final decision on a 510(k) submission, but the framework can improve the efficiency of 510(k) reviews. The review process is summarized below:

• 510(k) submitter sends submission to the 3PRO.
• 3PRO reviews submission and sends recommendation and documentation to FDA.
• FDA reviews the submission to ensure that the 3PRO has submitted all the information needed to make a final decision. If more information is needed, FDA makes a request of additional information, notifies the 3PRO, and puts the submission on hold.
• If necessary, the 3PRO reviews FDA’s request for additional information and notifies the 510(k) submitter. The 3PRO responds to FDA’s deficiencies.
• FDA reviews the additional information and makes a final decision.

FDA is updating the 3P Review Program to avoid the routine re-review of 510(k) submissions already reviewed by 3PRO. FDA is setting a goal that by the end of FY 2021, at least 85% of 3P submissions will not require substantive re-review by FDA. To achieve this, FDA is initiating new actions such as modifying the device types eligible for 3P review. The FDA Reauthorization Act (FDARA) of 2017 gave FDA the authority to amend its list of devices eligible for 3P review, removing some higher-risk devices from program qualifications and expanding the devices eligible for the program. FDA maintains a list of devices that are eligible for 3P review, which includes non-powdered patient examination gloves (class I), surgical lamps (class II), dental cement (class II), clinical electronic thermometers (class II), disposable contact lenses (class II), and mechanical wheelchairs (class I).

FDARA also required FDA to issue guidance on the factors FDA will use to determine whether a class I or class II device type is eligible for review by 3P Review Organizations. In the draft guidance document, “510(k) Third Party Review Program,” FDA outlined factors to determine eligibility in the 3P Review Program, summarized below:

1. What is the risk of the device type? Class III devices are ineligible for 3P review.
2. Is the device permanently implantable, life sustaining, or life supporting? 3PRO must provide justification for why a device type should be eligible for 3P review.
3. Is the device type well-understood? Complex special controls may make a device ineligible for 3P review.
4. Is all the necessary information available to 3PRO to make a recommendation? If necessary proprietary information cannot be shared with the 3PRO, the device type may be ineligible for 3P review.
5. Does the review require multifaceted, interdisciplinary expertise? Complex (clinical, non-clinical) data or a combination product that requires review from another Center in the Agency may make the product ineligible for 3P review.
6. Are there significant post-market safety signals? If post-market data suggests that the device type is the subject of safety signals, the device may be ineligible for 3P review.

The “510(K) Third Party Review Program” draft guidance also includes requirements and recommendations for recognition of 3PROs. As of December 24, 2018, there are 9 accredited organizations listed for performing 510(k) review. Recognition as a 3PRO requires renewal every 3 years. FDA has the authority to perform audits over the 3 years and can suspend or withdraw recognition of a 3PRO if the 3PRO is found to be not in compliance. There are many similarities between the 3PRO and International Medical Device Regulators Forum’s (IMDRF’s) Medical Device Single Audit Program (MDSAP) in terms of criteria for the organization’s qualifications and functions, such that an organization that is in compliance for MDSAP may be in compliance for the 3P Review Program.

Do you need assistance in preparing a 510(k) or do you want to know more about the regulatory pathway for your medical device? Please contact us at (248) 987-4497 or info@emmainternational.com.