FDA Dispute Resolution Process (CDRH)

Regulatory science is often considered a tricky subject since it mostly involves absolutes or issues that are not distinctively black or white. In such cases, regulators make decisions based on the basis of their best judgements formed in the context of the law, implementing regulations, and previous decisions on similar cases. In some cases, regulations are not sharply drawn and can lead to more than one conclusion. These can lead to strong differences in viewpoints between the FDA's decision and the officials of the medical device industry.

Such disputes with the FDA decision can be reviewed or reconsidered by the Dispute Resolution Processes. These processes are explained in Title 21 of the Code of Federal Regulations (CFR). These processes are applicable to resolve disputes involving 510k, PMA, IDE or PDP. The primary processes are often informal involving submission of a petition requesting change or internal review. The advantages and disadvantages of these processes are seen in the image below.

Other, more formal processes can be considered. These are often time-consuming and involve hearings either in a court, or before a board of scientists, an advisory committee, or the FDA Commissioner. The advantages and disadvantages of these processes are seen in the image below.

Other specific appeal processes are available for issues involving:
*Premarket Notification
*Investigational Device Exemption
*Product Development Protocol
*Premarket Approval
*Humanitarian Device Exemption
*Post-Market Surveillance Issues
*Regulatory Compliance Issues
*Product Designation Issues and other
*Miscellaneous Issues
These appeal processes can be seen explained in the "Medical Device Appeals and Complaints" document of the FDA. (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094523.pdf)