This guidance provides details on how types of devices are eligible for third party review and explain how third-party review organizations are being recognized.
The 38 paged guidance provides and explains in the details of the following,
· Factors it considers in determining the types of Class I and II devices that are eligible for third party review.
· The process for recognizing, re-recognizing, suspending and withdrawing recognition for third party review organizations.
· It is also highlighted that Class III devices are not eligible for the program.
One of the main objectives of this guide is to ensure the quality and standard of work of third party review organizations. This would in turn phase out the need for routine, substantive re-review done by FDA.
Further emphasis was also provided on the importance of the 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.