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HHS - 841 - Device Good Manufacturing Practice Advisory Committee - Statutory (Congress Created)


Committee NameDevice Good Manufacturing Practice Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number841
Original Establishment Date5/28/1976Committee StatusChartered
Actual Termination Date Committee URL
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*9
Current Charter Date5/17/1987Designated Fed Officer Position Title*Health Science Policy Analyst, Center for Devices and Radiological Health/FDA
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Aden
Exempt From Renewal*YesDesignated Federal Officer Middle NameS.
Specific Termination AuthorityDesignated Federal Officer Last Name*Asefa
Establishment Authority*Statutory (Congress Created)Designated Federal Officer SuffixM.P.H.
Specific Establishment Authority*21 U.S.C. 360c-jDesignated Federal Officer Phone*(301) 796-0400
Effective Date Of Authority*5/28/1976Designated Federal Officer Fax*(301) 847-8505
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*
Committee Type*Continuing
Committee Function*Scientific Technical Program Advisory Board


Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Device Good Manufacturing Practice Advisory Committee reviews proposed requirements for good manufacturing practices (GMPs) governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices. The committee reviews and provides recommendations on proposed GMP regulations and on petitions for exemption from GMP's regulations.
How is membership balanced?*By law, the composition of this committee is: three government representatives (local, state and federal); two health professionals; two industry representatives; and two representatives from the general public.
How frequent & relevant are cmte mtgs?*The committee meets approximately once a year or as required. In FY 2020 there were no issues necessary to be brought before the committee.
Why advice can't be obtained elsewhere?*This statutory committee is required under the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.
Why close or partially close meetings?N/A
Recommendation RemarksAlthough this committee did not meet in FY 2020, time was devoted to reviewing applications for new nominees, maintaining associated records for these activities, and streamlining paper processes within FDA. In addition, time was spent in the routine care and maintenance of the committee: the development of a financial report for this website; updating the roster and number of vacancies on our website; completing the annual ethics report; reviewing financial disclosures of current members and providing ethics training. Since the Committee did not meet, no reporting was required. There was no chairperson during FY 20. However, in FY 20 the Agency published a request for nominations in the Federal Register Notice, eager to receive nominations to fill the current vacancies (including the chairperson position).


Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherNo
Outcome Increased Customer SatisfactionYesAction CommentNA
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Device Good Manufacturnig Practice Advisory Committee enables the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentNA
Number Of Recommendations*1Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 1 recommendation from FY 03 through FY 20.Access Agency WebsiteYes
% of Recs Fully Implemented*75.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature and therefore, the Agency has the option of not implementing the advice. This number representatives an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*Feedback is provided in an indirect way. For example, with the regulation that was promulgated in 1996, the fact that the regulation was determined acceptable by the Agency and became law is a form of feedback. Also with the process validation guidance document, the document would not have been finalized without the support of various components, e.g., FDA's Office of the Chief Counsel.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Device Good Manufacturing Practice Advisory Committee supports FDA's mission and strategic action plan by reviewing proposed regulations and guidance documents intended to ensure the safety and effectiveness of medical devices and making recommendations to the Agency.
Hide Section - COSTS


Payments to Non-Federal Members*$0.00Est Payments to Non-Fed Members Next FY*$3,300.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$1,650.00
Payments to Federal Staff*$42,192.00Estimated Payments to Federal Staff*$124,545.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$5,473.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$2,736.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$52,740.00Est. Other Costs Next FY*$43,612.00
Total Costs$94,932.00Est. Total Next FY*$181,316.00
Date Cost Last Modified Est. Fed Staff Support Next FY*0.75
Federal Staff Support (FTE)*0.25Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Computer Technology
Food and Drugs
Medical Devices


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