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Posted 03 December 2012
For the second time in as many months, the US Food and Drug Administration (FDA) is calling on the public-and members of the medical device industry, in particular-to nominate new members to one of its advisory committees.
The latest call from FDA is in regards to its Device Good Manufacturing Practice Advisory Committee (DGMPAC), a group which advises the agency's Center for Devices and Radiological Health (CDRH) on quality manufacturing issues.
The committee also reviews proposed regulations and makes recommendations regarding their efficiency and "reasonableness," as FDA described it in a 3 December Federal Register posting.
"The committee also reviews and makes recommendations on proposed guidelines developed to assist the medical device industry in meeting the good manufacturing practice requirements, and provides advice with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations," FDA explained.
The committee currently has nine members, of which three are scheduled to leave the committee in May 2013. Two of those members-Elizabeth Blackwood of GE Healthcare and Cecilia Kimberlin of Abbott [Full disclosure: Kimberlin is also a RAPS Board member-Ed.]-are what are known as industry representatives-nonvoting members of the committee who can act as a voice for the industry. They are balanced out by two public representatives with a similar role.
Blackwood's appointment to the committee is scheduled to end in May 2013, and FDA's efforts seemed geared toward finding her replacement.
"FDA is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the DGMPAC in CDRH notify FDA in writing," FDA said. Nominees may be self-nominated or nominated by others, and require a current curriculum vitae and contact information.
FDA also invited all industry organizations interested in participating in the selection procedure to contact it within 30 days. All industry organizations will be required to "confer with one another and to select a candidate" by early February. If no nominees are suitable, FDA Commissioner Margaret Hamburg will personally appoint someone to the committee, per FDA regulations.
Nominations are due within 30 days of the notice's publication in the Federal Register (on or about 3 January 2013).
The notice marks the second time in as many months that FDA has sought new members for its advisory committees. A 4 October notice in the Federal Register indicated that the agency was seeking at least 11 individuals to serve as voting members of its committees, most of which were drug- and biologics-related.
Tags: medical device
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