SMG 2010.17 (09/17/2010) 1

SMG 2010.17

FDA Staff Manual Guides, Volume III - General Administration

FDA Official Councils and Committees

FDA Combination Products Policy Council

Effective Date: 09/17/2020

1. Purpose 

2. Policy 

3. Responsibilities 

4. Procedures 

5. Records of Council 

6. Effective Date 

7. History 

1. Purpose. 

As a part of the Food and Drug Administration’s (FDA) modernization of the 

regulation of combination products, the FDA establishes a policy council on 

combination products, cross-labeled products, and medical product classification 

(herein referred to as “Council”). This charter describes the duties and 

responsibilities of the Council, the organization of its membership, and its operating 

procedures. 

2. Policy. 

The Council will prospectively identify regulatory and scientific issues to address and 

function as a forum for developing guiding principles related to combination 

products, cross-labeled products, and medical product classification. The Council 

will also resolve disagreements among centers, the Office of Combination Products 

(OCP), and/or sponsors on activities and policies related to medical product 

classification and the clearance/approval of combination products and cross-labeled 

products. Of note, the Council is a resource to the FDA in general, on matters 

relevant to this subject. The Council does not meet directly with sponsors. 

The Council will ensure alignment of centers per new Intercenter Consult 

Agreements (provide link once available) which will include procedures regarding 

alignment of certain activities, (e.g., internal meetings and consult timelines). 

The Council will serve as the guiding body to facilitate development of a unified FDA 

position and resolve disagreements on cross-cutting matters arising from 

combination products, cross-labeled products, and medical product classification 
SMG 2010.17 (09/17/2010) 2

issues that affect more than one medical product center, including those related to 

designation requests. 

The Council will promote and coordinate communication both internally and 

externally on the policy decisions made by the Council. 

3. Responsibilities. 

A. The Council is responsible for: 

1. Reporting directly to the FDA Principal Deputy Commissioner who will serve 

as the Council Chairperson. If the position for FDA Principal Deputy 

Commissioner is vacant, the FDA Commissioner will appoint a Chairperson; 

2. Addressing complex issues relating to combination products, cross- labeled 

products, and medical product classification; 

3. Resolving disagreements among centers, OCP and/or sponsors. The Council 

will not meet directly with sponsors. If appropriate, a sponsor request for 

Council input may come through a Center or OCP; 

4. Promoting and coordinating internal and/or external communication of policy 

decisions when appropriate. 

B. Responsibilities of Council members: 

1. Representing their organizational unit’s views on issues under consideration 

by the Council; 

2. Serving as the focal point of contact for communicating with their 

organizational unit, including their senior managers about the deliberations of 

the Council and obtaining their input; 

3. Attending meetings in person or by teleconference. If a member cannot 

attend a meeting, an alternate may be designated by the Council member. 

The alternate must be able to represent the organization and vote in place of 

the member. If deemed appropriate by the Chairperson, email communication 

may be used to obtain Council input. 

4. Creating for Council review quarterly reports on combination products and 

cross-labeled products as well as decisions on medical product 

classifications, including information on: 1) clearances/approvals; 2) Request 

for Designations; 3) 10.75 appeals; and 4) 513(g)s. Information should 

include product names, labels, and the Center/Office decision. 

C. Responsibilities of the Council Chairperson: 
SMG 2010.17 (09/17/2010) 3

1. Directing the activities of the Council; 

2. Facilitating discussions on issues within the Council; 

3. Reviewing proposed issues and determining when issues are appropriate for 

Council review and discussion. If the proposal is not selected for Council 

review by the date specified, the Chairperson (through the Executive 

Secretary) will provide an explanation of this decision. Reconsideration by the 

Council of such decisions can be requested. 

D. Responsibilities of the Executive Secretary: 

1. Serving as the focal point for the working groups; 

2. Maintaining the roster for the Council and any working groups formed; 

3. Preparing documents and papers as requested by the Chairperson; 

4. Distributing documents relevant to the activities of the Council; 

5. Scheduling any pre-meetings as necessary and assisting in preparing 

materials for scheduled meetings; 

6. Arranging and organizing meeting logistics; 

7. Noting action items generated during the meetings of the Council and 

following-up on action items; 

8. Maintaining a repository that includes the quarterly reports, summaries of 

meeting discussions, a log and status of issues discussed and actions 

assigned, and copies of Council decisions and actions that can be accessible 

to all staff across centers. 

E. The Council is organized as follows: 

• The Council will be chaired by the Principal Deputy Commissioner or 

Commissioner Designee. The Council is comprised of two representatives 

from the Center for Biologics Evaluation and Research, the Center for Drug 

Evaluation and Research, and the Center for Devices and Radiological 

Health. The two representatives will include the Center Director and a named 

center representative to serve a two-year term. The Council will also be 

comprised of one representative from OCP and one from the Office of Clinical 

Policy and Programs (Office Director or designee). The Council is supported 

by an Executive Secretary. 
SMG 2010.17 (09/17/2010) 4

• Other participants, observers, and consultants from within the FDA (e.g., 

Office of the Chief Counsel and Office of Legislation) and from other Federal 

government organizations may participate, when appropriate, in the activities 

of the Council at the discretion of the Chairperson. The Council will follow 

applicable policies and procedures if information is to be shared outside FDA. 

• The Council may establish working groups or open dockets for public 

comments if needed. 

F. Responsibility of the Individual/Office/Center Seeking Council Evaluation: 

1. A proposal for a Council meeting may be submitted by any individual involved 

with the regulation and review of combination products and cross-labeled 

products as well as medical product classification. 

2. The requesting individual should submit a meeting request form (provide link) 

to the Executive Secretary for consideration by the Chairperson. This request 

form includes the following information: the issue to be resolved, the trigger 

that raised the issue, the date by which a response is needed, and 

concurrence of his/her Center or Office Director. 

3. Issues appropriate for Council deliberation include when there is no 

precedent for a regulatory decision, when there are disagreements among 

Centers, OCP, and/or sponsors, and when one center/office would like to 

change an existing practice or identifies a novel policy question. 

4. If the proposal is accepted, the requesting individual should provide a meeting 

background document (provide link) to the executive secretary for review at 

least two weeks before the Council meeting. The background document 

should provide all the necessary information to understand the issues to be 

discussed. 

4. Procedures. 

• A request for Council deliberation will not delay review deadlines and a Council 

decision does not replace the existing formal appeals process for sponsors. 

However, all 10.75 appeals that raise cross-cutting issues involving combination 

products, cross-labeled products, and medical product classification should be 

brought to the Council for discussion prior to issuance of a decision. 

• Formal disputes that relate to internal differences of opinion regarding scientific 

or regulatory issues will follow the policies and procedures as described in the 

2014 SMG 9010.2: Cross-Center Dispute Resolution at the FDA. 
SMG 2010.17 (09/17/2010) 5

• Experts from Agency staff will be sought and invited to participate in the 

discussion at the Chairperson’s discretion. Suggested attendees may be 

provided in the meeting background document. 

• The individual/office/center seeking Council evaluation will provide a brief (e.g., 

10-minute) overview of the issues at the beginning of the meeting. 

• Decisions will be established by a formal vote after deliberation among all parties 

attending the Council meeting. Each center and OCP will be entitled to one vote 

each (four votes total). If the vote is tied, the Chairperson has decisional 

authority. The Chairperson may present a case to the FDA Commissioner for a 

final decision. 

5. Records of Council. 

A. The Chairperson and the executive secretary will assure that the activities of the 

Council, including quarterly reports, recommendations, decisions, issues, action 

items, and other pertinent materials attributable to the Council, are documented 

and communicated to senior management and relevant staff, as appropriate. 

B. The Council will review this charter at least annually based on experience gained 

by the Council and revise it as needed. 

6. Effective Date. 

The effective date of this charter is September 17, 2020.

7. Document History – SMG 2010.17, “FDA Combination Products Policy 

Council”

Status 

(I, R, C)

Date 

Approved

Location of 

Change 

History

Contact Approving Official

Initial 10/02/2016 N/a CDER/OMIO Robert M. Califf, M.D., 

Commissioner of Food and Drugs

Change 04/13/2017 4.Procedures OC/OMPT

Dr. Rachel Sherman, Deputy 

Commissioner OMPT, Chair CPP 

Council

Revision 09/14/2020 N/a OO/OB/DBFPA/

PAT

Stephen M. Hahn, M.D., 

Commissioner of Food and Drugs

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