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Posted 17 January 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) is seeking new industry members industry to serve on two of its medical device-focused advisory committees, it announced today.
In a 17 January 2014 announcement in the Federal Register, FDA said it is soliciting nominations for both the Medical Devices Advisory Committee (MDAC) and three of MDAC's more specific panels: the Dental Products Panel, the Hematology and Pathology Devices Panel, and the Immunology Devices Panel.
In a separate notice, FDA also said it is seeking non-voting industry representatives to serve on its Device Good Manufacturing Practice Advisory Committee (DGMPAC), which makes recommendations on device manufacturing, distribution and use issues.
"Persons nominated for the [MDAC] should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry," FDA wrote in the Register notice.
For the DGMPAC, nominated persons need only "possess appropriate qualifications to understand and contribute to the committee's work as described in the DGMPAC's function," regardless of their ties to industry.
Individuals may self-nominate themselves for the advisory committee. Organizations, too, may nominate candidates or groups of candidates.
Companies interested in the selection process should, within 30 days, send a letter of interest to FDA. After 30 days, FDA will compile a list of all nominated persons and send that list to organizations which have expressed interest. The organizations will then need to collectively select a candidate to serve on the MDAC and its panels within 60 days. Failure to select a nominee will result in FDA choosing one on behalf of industry.
All selected persons would serve in a non-voting, advisory capacity.
Federal Register Notice: MDAC
Federal Register Notice: DGMPAC
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