The Center for Devices and Radiological Health (CDRH) of the U.S. FDA decides to seek expert advice and form an advisory panel to evaluate and review data on the norms surrounding the safety and effectiveness concerning the marketed and investigational devices. The experts will also form as the voting members for the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and panels that make up the Medical Devices Advisory Committee (MDAC).
The experts that are required for the DGMPAC, for medical device quality management system requirements/current Good Manufacturing Practices, are desired to have experience in both 21 CFR part 820 and International Organization for Standardization (ISO) 13485. For General and Plastic Surgery Devices Panel of the MDAC, there are 4 experts needed, while Immunology Devices Panel of the MDAC requires five experts, as per the FDA.