FACACLASSIC

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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”

HHS - 916 - Medical Devices Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Medical Devices Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	916
Original Establishment Date	5/28/1976	Committee Status	Chartered
Actual Termination Date		Committee URL	https://www.fda.gov/AdvisoryCommittees/Committe...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	159
Terminated This FY	No	Designated Fed Officer Position Title*	Program Analyst, Center for Devices and Radiological Health/FDA
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	8/18/1999	Designated Federal Officer First Name*	Evella
Date Of Renewal Charter		Designated Federal Officer Middle Name	F.
Projected Termination Date		Designated Federal Officer Last Name*	Washington
Exempt From Renewal*	Yes	Designated Federal Officer Suffix
Specific Termination Authority		Designated Federal Officer Phone*	(301) 796-6683
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*
Specific Establishment Authority*	21 U.S.C. 360j(f)(3)	Designated Federal Officer Email*	evella.washington@fda.hhs.gov
Effective Date Of Authority*	5/28/1976
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not 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 2025, 2 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 individuals of all genders and racial groups are encouraged to apply for vacancies.
How frequent & relevant are cmte mtgs?*	The Committee had two meetings in FY 2025 and tentatively plans four 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 2025, the Panels convened to discuss, make recommendations and vote on the following two De Novo requests : (1) The General and Plastic Surgery Devices Panel had 2 meetings. The first was the ProSense Cryoablation System sponsored by IceCure Medical Ltd. The discussion focused on the sponsor’s proposed indication: “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.; and the second was a general issues meeting to discuss a new indication for use for dermal filler devices in the décolletage area and will make recommendations regarding risks associated with new indications for use such as in the décolletage area, the potential impact of filler material on imaging studies and clinical exams (e.g., breast cancer screening), pre-market and post-market study assessments for benefit and risk, removal of dermal filler implant material and patient preference.
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 Remarks	The Panels of this Committee meet as needed, rather than on a regular basis; therefore, some Panels did not meet during FY 2025 and have no reporting requirements. For the Panels that did not meet, considerable time was also devoted to reappointing current members, maintaining associated records for these activities, and streamlining 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 nominees and providing ethics training.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve an investigational new medical product or other regulatory decision-making.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The 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 Comment	NA
Number Of Recommendations*	366	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 366 recommendations from FY03 through FY24.	Access Agency Website	Yes
% of Recs Fully Implemented*	85.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	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.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:33 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Food and Drugs Food and Drugs Medical Devices Government Federal Government Health Public Health

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