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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 916 - Medical Devices Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameMedical Devices Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number916
Original Establishment Date5/28/1976Committee StatusChartered
Actual Termination Date Committee URLhttps://www.fda.gov/AdvisoryCommittees/Committe...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*159
Current Charter Date8/18/1999Designated Fed Officer Position Title*Panel Coordinator, Medical Devices Advisory Committee
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*James
Exempt From Renewal*YesDesignated Federal Officer Middle NameP.
Specific Termination AuthorityDesignated Federal Officer Last Name*Swink
Establishment Authority*Authorized by LawDesignated Federal Officer Suffix
Specific Establishment Authority*21 U.S.C. 360j(f)(3)Designated Federal Officer Phone*(301) 796-6313
Effective Date Of Authority*5/28/1976Designated Federal Officer Fax*(301) 847-8505
Exempt From EO 13875 Discretionary CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*james.swink@fda.hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Medical Devices Advisory Committee provides advice to FDA on the safety and effectiveness of marketed and investigational devices, the classification of devices into one of three regulatory categories, the possible risks to health associated with the use of devices, the formulation of product development protocols, the review of premarket approval applications, and the content of guidelines or guidance documents designed to improve the interaction between the Agency and sponsors of medical devices. This committee consists of 18 advisory panels: 17 are divided according to medical specialties and one is a dispute resolution panel. In FY 2020, three meetings were held.
How is membership balanced?*Members are drawn from the nation's top academicians, clinicians and researchers and they provide expertise in a full range of medical specialties. These medical specialties include anesthesiology, cardiac catheterization and electrophysiology, cardiology, cardiothoracic and vascular surgery, radiation physics, radiotherapy, mammography radiology, biomaterials, cytopathology, molecular genetics, clinical toxicology, chemical engineering, orthopaedic surgery, biostatistics, gastroenterology, nephrology, esophageal disorders, trauma, burn and wound plastic surgery, surgical oncology, reconstructive plastic surgery, periodontology, biochemistry, immunology, oral and maxillofacial surgery, vision sciences, corneal disease, ophthalmological surgery, perinatology, reproductive endocrinology, obstetrics and gynecology, neurology, cerebrovascular surgery, interventional neuroradiology, neurological surgery, neurological disorders and stroke, and pediatric surgery. There is at least one consumer and industry representative per panel and while they do not vote, they do provide viewpoints from their respective constituencies. Qualified females and minorities are encouraged to apply for vacancies.
How frequent & relevant are cmte mtgs?*The Committee had three meetings in FY 2020 and tentatively plans 12 meetings for the coming year to address new technologies coming to market and to address questions that may arise about existing technologies and classification issues. The scope and depth of expertise that Committee members possess is not always available within the Agency; therefore, the Panel meetings provide a source of expert advice to the Agency on premarket review decisions, postmarket issues, classification and reclassification decisions, early discussion of study designs, and guidance documents. During FY 2020, the Panels convened to discuss potential methods to reduce ethylene oxide (EtO) emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing; technological design advancements and effective reprocessing of duodenoscopes to reduce the risk of infections; and immunological responses to metal-containing products, focusing on metal-containing implants and dental amalgam. The Panels also discussed and made recommendations on reclassification of non-invasive bone growth stimulator devices and classification of facet screw spinal device systems, intracompartmental pressure monitors, intra-abdominal pressure monitoring devices, and cemented total first metatarsophalangeal joint implants.
Why advice can't be obtained elsewhere?*Committee members are selected from academia, research, and/or clinical practice. The advice they provide helps decisions stand up under public scrutiny and offers credibility to the regulatory process. The goals of the committee can only be met using these alternate means to obtain sound advice.
Why close or partially close meetings?N/A
Recommendation RemarksThe Panels of this Committee meet as needed, rather than on a regular basis; therefore, some Panels did not meet during FY 2020 and have no reporting requirements. For the Panels that did not meet, considerable time was devoted to preparation for meetings that were postponed due to the COVID-19 pandemic; considerable time was also devoted to reappointing current members, 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.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

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 OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve an investigational new medical product.
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 Medical Devices 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 services 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*317Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 317 recommendations from FY03 through FY20---See question 20a of the ACR for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*85.00%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.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%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. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*It usually does. Product approval issues are first released to the sponsor. When appropriate information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly when implemented.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 Panels (of the Medical Devices Advisory Committee (MDAC)) of the Center for Devices and Radiological Health (CDRH) Advisory Committee organized under 513(b) of the Federal Food, Drug and Cosmetic Act supports the FDA mission and strategic plan by providing independent expert scientific advice on the safety and efficacy of medical devices and radiation emitting products. The Panels also offer an opportunity for public input on all the issues that attend the introduction of new medical devices.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$22,641.00Est Payments to Non-Fed Members Next FY*$69,300.00
Payments to Federal Members*$1,090.00Est. Payments to Fed Members Next FY*$4,400.00
Payments to Federal Staff*$2,299,353.00Estimated Payments to Federal Staff*$2,154,935.00
Payments to Consultants*$47,011.00Est. Payments to Consultants Next FY*$195,800.00
Travel Reimb. For Non-Federal Members*$13,110.00Est Travel Reimb Non-Fed Members nextFY*$40,923.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$40,042.00Est Travel Reimb to Consultants Next FY*$161,099.00
Other Costs$693,101.00Est. Other Costs Next FY*$817,440.00
Total Costs$3,116,348.00Est. Total Next FY*$3,443,897.00
Federal Staff Support (FTE)*14.89Est. Fed Staff Support Next FY*12.75
Cost RemarksFor the Panels that did not meet, considerable time was devoted to preparation for meetings that were postponed due to the COVID-19 pandemic.
The Payments to Consultants cost includes the value of 18 meeting days of service by regular Government employees from other Agencies.
Est Cost Remarks
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Medical Devices
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-036620Medical Devices Advisory Committee2019
 COM-034833Medical Devices Advisory Committee2018
 COM-001692Medical Devices Advisory Committee2017
 COM-002562Medical Devices Advisory Committee2016
 COM-004141Medical Devices Advisory Committee2015
 COM-004461Medical Devices Advisory Committee2014
 COM-005906Medical Devices Advisory Committee2013
 COM-006498Medical Devices Advisory Committee2012
 COM-008024Medical Devices Advisory Committee2011
 COM-008736Medical Devices Advisory Committee2010
 COM-010307Medical Devices Advisory Committee2009
 COM-010671Medical Devices Advisory Committee2008
 COM-012284Medical Devices Advisory Committee2007
 COM-012862Medical Devices Advisory Committee2006
 COM-014016Medical Devices Advisory Committee2005
 COM-014446Medical Devices Advisory Committee2004
 COM-015656Medical Devices Advisory Committee2003
 COM-016467Medical Devices Advisory Committee2002
 COM-017842Medical Devices Advisory Committee2001
 COM-018633Medical Devices Advisory Committee2000
 COM-019861Medical Devices Advisory Committee1999
 COM-020338Medical Devices Advisory Committee1998
 COM-021730Medical Devices Advisory Committee1997