Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a draft guidance, titled “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA’s guidance documents from 2001 and 2004.
The objectives set forth in the draft guidance are to outline: (1) the factors FDA will use in determining device type eligibility; (2) the FDA’s process for the recognition, rerecognition, suspension and withdrawal of recognition for 3P Review Organizations; and (3) steps toward consistent quality of work among 3P Review Organizations.
According to the draft guidance, the 3P Review Program will allow the FDA to focus its internal scientific review resources on higher-risk and complex devices, while confidently depending on the 3P Review Organizations for the review of low-to-moderate risk and less complex devices. Participation in the 3P Review Program is voluntary. The guidance lists a number of factors for determining device eligibility, which include:
- The risk posed by a given type of device (class III devices, for example, are not eligible); whether the device is permanently implantable, life sustaining, or life supporting;
- The extent to which the device type is well understood;
- Whether the information materially relevant to evaluating the submission is proprietary and cannot be shared outside the agency;
- Whether multifaceted and interdisciplinary expertise is necessary for review (certain clinical data or complex non-clinical data, multi-reader clinical studies, combination products or device types, and devices needing cross-labeling considerations are ineligible); and
- The availability of post-marketing data implicating safety.
The guidance also notes that FDA will periodically update the product code classification data base and list of devices eligible for 3P Review.
The guidance makes recommendations regarding review made by the 3P Review Organizations, which the guidance characterizes to “share FDA’s mission to protect and promote the public health by ensuring medical devices are safe and effective for their intended uses.” The FDA suggests the 3P Review Organization take the following steps: determine whether the device type is eligible for 3P review; assign Product Specialist(s) and Technical Expert(s) with the appropriate education, training, technical knowledge and the like for the device type(s) the organization will review; obtain and be familiar relevant FDA guidance(s) and information (such as guidances, special controls, postmarket databases, premarket review information in FDA’s 510(k) database, and standards); ensure the submission is administratively complete; conduct a substantive review of the submission; and make a final recommendation to the FDA by preparing a review documentation that specifying the reasoning and steps that led to the final determination for the submission. The FDA promotes early consultation with the FDA, if needed. The FDA expects 3P Review Organizations to identify any deficiencies and document the reasoning and steps that led to their final recommendation, and provide additional information upon FDA’s request. If a 3P Review Organization submits a 510(k) to FDA for an ineligible device or a device that organization is not recognized to review, the FDA will place the submission on a hold. If the 3P Review Organization does not address the eligibility concerns or withdraw the submission within 180 days, FDA will delete the file. A 510(k) Submitter cannot submit a 510(k) for the same device directly to FDA until the 3P Review Organization’s submission is withdrawn voluntarily by the organization or is automatically deleted by FDA.
As a step toward consistent quality of work among 3P Review Organizations, the guidance focuses on the requirements recognition and rerecognition of the 3P Review Organizations. The criteria for recognition or rerecognition include that the 3P Review Organization must be an independent organization that is controlled neither by the federal government nor by a manufacturer, supplier, or vendor of devices or the like, making them impartial and free from any commercial, financial, and other pressures that might present a conflict of interest. The guidance provides that the personnel retained by the 3P Review Organization must have relevant knowledge and experience for the devices that the 3P Review Organization is recognized to review. The guidance states that the 3P Review Organizations will be expected to consult national and/or international standards recognized by FDA as well as FDA guidance documents. The guidance provides steps for obtaining recognition as a 3P Review Organization. The recognition sunsets after three years and obtaining rerecognition would be required to continue functioning as a 3P Review Organization.
Finally, the guidance provides details for complying with the International Medical Device Regulators Forum’s (IMDRF) requirements for the Medical Device Single Audit Program (MDSAP). There are many similarities between these regimes, and the draft guidance provides a side-by-side comparison for leveraging existing documentation of applications submitted to FDA.
In summary, the proposed plan will permit the FDA to focus its resources on higher-risk and complex devices. It also provides guidance for identifying device types that are eligible for the 3P Review Program, as well as provides systematic guidance for the 3P Review Organizations for conducting review and improving quality of the 3P Review Program.