April 11, 2013: Device Good Manufacturing Practice Advisory Committee Meeting Announcement
|CDRH||April 11, 2013||8:00 a.m. - 6:00 p.m.|
Hilton Washington DC North/Gaithersburg
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (Agency or FDA). The meeting will be open to the public.
Name of Committee: Device Good Manufacturing Practice Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 66, rm. 1544, Silver Spring, MD 20993-0002, 301-796-5290, Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda: On April 11, 2013, the committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA’s current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. In a separate Federal Register notice, FDA is seeking additional broad public input about the effects of extreme weather on medical device safety and quality.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 4, 2013. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 p.m. Oral presentations from industry, professional organizations, and societies that have an interest in this topic will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 27, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 29, 2013.
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Committee Management Staff, at AnnMarie.Williams@fda.hhs.gov
or 301-796-5966, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: February 14, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
April 11, 2013: Meeting Materials FDA Generated