The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to authorize third party organizations to review certain 510(k) submissions and issue initial classification determinations. The reviewers then forward their recommendations to FDA for a final determination of substantial equivalence. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in 2012, required that FDA create accreditation criteria for third party review organizations; this draft guidance establishes the criteria mandated by FDASIA. A second purpose of the draft guidance is to encourage harmonization between the TP Review Program and the international standards established by the International Medical Device Regulator Forum’s Medical Device Single Audit Program.

Third party review can only be used for 510(k)s for Class I and certain Class II medical devices. Using third-party review for these lower-risk devices allows CDRH to focus its internal resources on more complex and riskier devices. Devices that are not eligible for the TP Review Program include:

• All Class III devices 
• Class II devices that are permanently implanted 
• Class II devices intended to sustain or support life 
• Devices that require clinical data 
• Products that require multi-Center review or consultation (e.g., combination products)

The guidance covers both how an organization can become recognized as a third party reviewer and how the third party review process works. To be recognized as a third party reviewer, an organization must be free of any potential conflicts of interest with both the medical device industry and FDA, and have personnel qualified to review specific classes of devices. TP review organizations are recognized for particular types of medical devices, based on their areas of expertise. Currently, only seven organizations are accredited third party reviewers. FDA performs both periodic and for-cause assessments of TP review organizations, which may include a physical inspection of the organization’s facilities and records. FDA also will monitor and audit the TP review organization’s submissions. If nonconformity with the TP Review Program criteria is discovered, FDA may suspend or withdraw recognition of the TP review organization, after notice and opportunity for an informal hearing.

When a 510(k) is submitted, the TP review organization first determines if the device type is eligible for review under the program and that the submission is administratively complete. Next, the 510(k) is assigned to a product specialist for the particular device type, who will perform the substantive review, with the assistance of a technical expert if necessary. A final reviewer within the organization then submits the 510(k) to FDA, along with the organization’s recommendation regarding substantial equivalence. If FDA requires additional information, it will be requested from the TP review organization. FDA’s final decision is issued to the TP review organization, which then relays it to the submitter.

Once this guidance is finalized, it will supersede earlier guidances on the TP Review Program, with the exception of the review templates in Appendices 2-4 from the 2004 “Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications.” References to the templates from the earlier guidance have been incorporated into this guidance. Within six months of the finalization of the guidance, TP review organizations should submit applications for recognition under the program. A TP review organization’s recognition lasts for three years, after which the organization must request re-recognition through the same process.

AGG Observations

1. For manufacturers, the primary benefit of the Third Party Review Program is an expedited decision timeline. Once FDA receives the recommendation from the TP reviewer, it must issue a determination of substantial equivalence within 30 days. Note that if FDA requests additional information during its review, the review clock will be paused. Only 510(k)s submitted through the Third Party Review Program get the 30 day review clock. 
2. Instead of paying a user fee to CDRH, medical device manufacturers opting to use the Third Party Review Program will contract directly with the review organizations. Fees are not standardized, so costs may vary between organizations and could exceed the user fee. Therefore, manufacturers should consider comparing prices. However, an expedited review time means manufacturers may be able to get devices on the market sooner, potentially recouping the increased review fee in earlier sales revenue. 
3. If the 510(k) submitter disagrees with FDA’s final decision, it will have to dispute the decision directly with FDA. Third Party Review organizations must remain impartial and avoid conflicts of interest; therefore, they will not advocate on a submitter’s behalf.