FDA Finalizes 510(k) Third Party Review Program Guidance
The US Food and Drug Administration (FDA) on Wednesday finalized guidance on its 510(k) third party review program (3P510k) detailing how it will determine whether different types of devices are eligible for third party review and explaining how third party review organizations are recognized under the program.The final guidance comes after FDA responded to comments submitted to the 2018 draft version of the guidance last October.
Within the 38-page guidance, FDA explains the factors it considers in determining the types of Class I and II devices that are eligible for third party review, as well as its process for recognizing, re-recognizing, suspending and withdrawing recognition for third party review organizations. FDA notes that Class III devices are not eligible for the program.
FDA also says that one of its goals for the guidance is to ensure the quality of work done by third party review organizations as part of its commitment under the Medical Device User Fee Amendments (MDUFA IV) “to eliminate the need for routine, substantive re-review by FDA.”
Specifically, the guidance lists six criteria FDA will consider for determining device type eligibility for the program, including the risk posed by the device and whether it is “intended to be permanently implanted in the human body, to sustain human life, or to support human life.”
FDA says it will consider “the extent to which the device type is well understood” and the “extent to which necessary information to make a well informed recommendation is available to 3P510K review organizations,” in the case that materially relevant proprietary information cannot be shared outside the agency.
The guidance also emphasizes the importance of International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) and Good Regulatory Review Practices (GRRP) working group documents for potential 3P510K review organizations, noting that it believes organizations in compliance with MDSAP and GRRP documents “are likely to be in compliance with most FDA 3P510K review organization requirements and meet the recommendations in this guidance document.”
FDA notes that the guidance supersedes two earlier guidances, the 2001 guidance Implementation of Third Party Programs Under the FDA Modernization Act of 1997 and the 2004 guidance Third Party Review of Premarket Notifications.
FDA