How are FDA GMP Guidelines on the Regulation of Medical Devices made?

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7/8 May 2024

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Have you also always wondered how the FDA gets its guidelines? As concerns GMP documents on the regulation of medical devices the "Device Good Manufacturing Practice Advisory Committee" (DGMPAC) plays an important role. It reviews drafts for guidelines on the regulation of medical devices within the FDA. In doing so the Committee almost has the function of a "bridge" between the Commissioner of the FDA and the CDRH, the corresponding department for medical devices. Insofar, the Commission also advises the Commissioner with regard to petitions submitted by industry for an exemption concerning GMP.

An extensive description on the FDA website elaborates in detail on the DGMPAC. The Committee consists of nine members including the Chair. The composition is very heterogeneous. 3 members shall be representatives of authority, two members shall be representatives of the interests of the device manufacturing industry and two shall be representatives of the interests of physicians. The last two members shall be representatives of the interests of the general public in the Committee. The Committee meets at least once a year. Meetings are open to the public except as determined otherwise by the Commissioner. The description also contains the compensation for members who are not full-time Federal employees.

Please see the detailed description of the DGMPAC in the "Charter of the Devices Good Manufacturing Practice (GMP) Advisory Committee".