SMG 7100.1 (07/01/2016) 1

SMG 7100.1

FDA STAFF MANUAL GUIDES, VOLUME IV – AGENCY PROGRAM DIRECTIVES

COMPLIANCE

MANAGEMENT OF THE FDA COMPLIANCE POLICY GUIDES MANUAL

Effective date: 07/01/2016

1. Purpose

2. Policy

3. Responsibilities 

4. Procedures

5. Records

6. Amendment of this SMG

7. Supporting Information

8. Effective Date

9. Document History

Attachment A – CPG Format and Content

1. PURPOSE.

The FDA Compliance Policy Guides (CPGs) manual provides a convenient and organized 

system for issuing statements or explanations of compliance policy to FDA staff. CPGs provide 

interpretations of FDA statutory or regulatory requirements as agreed upon by the Office of 

Regulatory Affairs (ORA) and program centers or offices.

FDA Centers and other components responsible for a specific regulatory program area issue 

CPGs (see Volume I of the FDA Staff Manual Guides for functional statements by organization). 

FDA may issue CPGs for many reasons, including new legislation, regulations, guidances, court 

decisions, and similar legal, scientific, and public health factors.

This Staff Manual Guide (SMG) establishes procedures for developing and maintaining FDA 

compliance policies that collectively make up the CPG manual. This SMG does not cover the 

agency procedures that are part of typical guidance development activities. 

2. POLICY. 

A. CPGs are guidance documents prepared for FDA staff as defined in the good guidance 

practices (GGPs) regulations found in 21 CFR 10.115.

B. Consistent with GGPs and to promote transparency, CPGs are available to the public on the 

FDA internet and notices are published in the Federal Register (FR) as required in the 

advisory opinion regulations found in 21 CFR 10.85.

C. The development and clearance of CPGs and FR notices is a collaborative process involving 

the organizations pertinent to the program topic.
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3. RESPONSIBILITIES.

This SMG covers responsibilities in the CPG process for the offices listed below. The term 

“CPG” in these responsibilities also encompasses the associated FR notice. Other FDA offices 

involved in the clearance and issuance of guidance documents and associated FR documents 

follow existing agency procedures (for example, FDA Office of Policy clearance, or use of the 

Federal Register Document Tracking System, FRDTS). 

A. Joint Responsibilities. The development and issuance of CPGs requires cooperation 

between the originating and collaborating offices. These offices: 

1. Collaborate on the strategic and tactical direction of compliance policy, including 

objectives and implementation

2. Seek and provide input for operational considerations relevant to the compliance policy’s 

regulatory and enforcement guidance, and recommend changes

3. Monitor CPGs’ relevance and accuracy and make corrections or revisions, or withdraw

obsolete CPGs

4. Inform affected FDA staff of new, revised, and withdrawn CPGs

5. Update this SMG to reflect changes in the management of the CPG manual

B. Originating Office. The FDA office accountable for a program’s compliance policy:

1. Develops new or revised CPGs conforming to the requirements of GGPs, FDA

procedures, the originating office’s procedures, and this SMG

2. Coordinates reviews and clearances of new, revised, and withdrawn CPGs within the 

scope of this SMG

3. Coordinates with ORA for CPG internet posting or withdrawal, notifying FDA staff of 

CPG changes, and maintaining CPG internet page information

4. Ensures official records of the development, clearance, withdrawal, and issuance of a 

CPG are maintained

5. Collects feedback on CPGs from FDA staff and other stakeholders, and acts upon the 

feedback

6. Reviews CPGs and proposes revisions or withdrawals, as appropriate, in accordance with 

internal procedures and timeframes (reference 21 CFR 10.115 (k))

C. Collaborating Office. Each collaborating office:

1. Provides input to the originating office during development, revision, and withdrawal of 

CPGs 

2. Coordinates internal review of new or revised CPGs or of a recommendation to withdraw

a CPG

3. Provides consolidated comments to the originating office

D. Office of Regulatory Affairs (ORA). Designated offices and committees within 

ORA:
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1. Act as an originating or collaborating office depending on the subject matter of the CPG

2. Provide subject matter expertise and staff-level reviews of CPGs for consistency with 

other agency CPGs 

3. Coordinate resolution of policy disputes or inconsistencies between major program areas 

4. Coordinate ORA review and clearance of new or revised CPG, or of a recommendation 

to withdraw a CPG

5. Manage numbering and web-posting for CPGs and related internet pages, according to 

written internal procedures 

4. PROCEDURES.

A. Maintaining Information for the CPG Manual.

1. General: The CPG manual is located within the FDA Staff Manual Guide Volume IV, 

Program Directives, 7100 series. 

2. Organization: The CPG manual is organized by chapters for general topics and for 

specific FDA program areas. A chapter consists of individual CPGs organized by subchapters. ORA assigns unique CPG chapter, sub-chapter, and section numbers, according 

to internal procedures. 

3. Access: For public access, ORA maintains the CPG page on the FDA internet, the CPG 

manual’s chapter lists for each program area and the manual’s change history 

information. For FDA staff, ORA maintains a CPG/CPGM Resources page on the FDA 

intranet to provide links to contacts, instructions, templates, and transmittals, plus links to 

relevant ORA procedures. (See §7.B for internet and intranet link information.)

4. Formatting: The originating office formats CPGs according to GGP requirements for 

draft and final guidance documents. Some older CPGs are not in guidance format: if the 

originating office revises a pre-guidance-format CPG, they add the appropriate guidance 

identification information (see Attachment A).

B. Initiating Development, Revision, or Withdrawal of a CPG.

1. Initiate Action 

a. The originating office may develop, revise, or withdraw a CPG in response to:

(1) New policy or changes in compliance policy (for example, Office of the 

Commissioner memoranda, center memoranda and other informational issuances, 

agency correspondence with trade groups and regulated industries, and advisory 

opinions)

(2) Precedent-setting court decisions 

(3) Multicenter agreements regarding jurisdiction over FDA-regulated products

(4) Preambles and final regulations or other FR documents 

(5) Significant regulatory actions or public health events

(6) Information from FDA staff and other users and stakeholders

(7) Technical or scientific information, such as risk and data analyses, etc.
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b. The originating office considers if they should list CPG action in a guidance agenda if 

the Center or office posts such a list (for example, “CDRH Fiscal Year 2016 

Proposed Guidance Development. . .”)

c. The originating office determines, in consultation with OCC:

(1) If the CPG action is designated as a GGP level 1 or 2 action (see 21 CFR 

10.115(c))

(2) If a new or revised CPG will be issued as a Draft CPG or a Final CPG

NOTE: The originating office may be exempt from the FR notice requirement in the 

limited circumstance of a simple correction of a CPG.

2. Collaborate

a. The originating office, using contact information available in the FDA intranet

“CPG/CPGM Resources” page: 

(1) Notifies ORA of planned action according to contact information available on the 

CPG information page on the FDA intranet

(2) Works in conjunction with collaborating offices in developing a new or revised 

CPG, a withdrawal, and the associated FR notice.

(3) Manages collaborative consults with Office of Chief Counsel 

(4) For new CPGs, contacts ORA for document numbering 

b. Staff in collaborating offices keep their respective management informed of progress.

c. The originating office submits the CPG and FR collaborative drafts for review.

C. Reviewing a CPG and FR Notice.

1. The originating office sends a pre-clearance review request and instructions to the 

collaborating offices for staff-level reviews (also known as “staff clearance”). 

A collaborating office manages its internal review process in order to return relevant, 

authoritative, non-conflicting, consistent, and consolidated comments to the originating

office.

After examining the comments, the originating office works to resolve differences. In 

some cases, the originating office may repeat the collaboration and review stages. Use the 

following decision-making roles to help resolve differences:

a. The originating office is the lead for:

(1) Interpretation of regulation and policy (with OCC consultation as appropriate)

(2) Regulatory and scientific issues related to the compliance policy

(3) Regulatory action guidance

b. ORA is the lead for: 

(1) Policy analysis of regulatory guidance 

(2) ORA operational issues that may be impacted by the CPG 

(3) Numbering and formatting requirements

(4) Accessibility requirements and web posting 

The originating office prepares the reconciled CPG and FR notice for clearance. 
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D. Clearing a CPG and Federal Register Notice.

NOTE: The originating office uses FRDTS, or its successor system, to obtain clearances; if 

there is no FR notice due to CPG correction, the originating office uses clearance form FDA 

2306, Clearance Record.

1. Concurrence: The originating office obtains management concurrence from the 

appropriate clearing officials prior to forwarding the CPG and associated FR notice for 

final guidance approvals and posting. The appropriate officials are: 

a. For ORA, the ORA Assistant Commissioner for Compliance Policy provides the 

concurrence signature even if multiple ORA offices are collaborators.

b. For other non-ORA collaborating offices, the concurrence signature is established in 

the office’s internal procedures. 

2. Final approval: The originating office determines the final approval signature based on their 

procedures for guidances and FR documents.

E. Issuing or Withdrawing a CPG.

1. Posting

a. The originating office, using contact information available in the FDA intranet

“CPG/CPGM Resources” page, coordinates with ORA in advance of the planned 

action date on posting—or removing—appropriate CPG documents and information.

b. The originating office provides ORA an editable electronic version of the cleared 

Draft CPG or Final CPG with anticipated action dates entered on first page, and, as 

appropriate, on the last page.

c. In synchronization with the issuance of the FR notice, ORA, according to internal 

procedures for editing the CPG internet page:

Makes changes to For Draft CPG For Final CPG For Withdrawn 

CPG

CPG internet page 

revision/update

history

Add update Add update Add update

Document on 

internet

Post in new URL Add issue date and post Remove 

CPG internet page 

chapter lists

n/a Edit listing as needed Remove listing

2. Notification

a. The FR notice and the CPG internet page’s Revision/Update section provide notice to 

FDA stakeholders. At their discretion, the originating office may highlight CPG 

changes on its own internet pages.

b. The originating office is encouraged to use an email transmittal to notify internal staff 

of CPG changes (see FDA intranet “CPGM & CPG Resources” page for a transmittal 

template). Collaborating offices may send internal transmittals. 
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3. Feedback

a. GGP regulations provide mechanisms for FDA stakeholders to provide input and 

participate in the CPG process (reference 21 CFR 110.115(f) & (g)).

b. Originating offices are encouraged to maintain a documented process by which FDA 

staff may comment internally on final CPGs and a procedure for evaluating and 

acting on both internal and external comments to ensure CPGs are current and clear.

5. RECORDS.

A. The originating office follows record management policies and procedures for draft, final, 

superseded, and withdrawn guidance documents and associated FR Notices.

B. For convenience, ORA will maintain a copy of the editable version of the CPG at the 

originating office’s request. 

Note: For CPGs, apply FDA programmatic record control schedule file code 1200.

6. AMENDMENT OF THIS STAFF MANUAL GUIDE. 

A CPG originating office, as defined in this SMG, may edit this SMG and the issue the revision 

without full agency clearance in limited circumstances. (FDA SMGs 3280.1 and 3280.2 describe 

SMG management.)

A. The circumstances allowing originating office edits to this SMG without full agency 

clearance are constrained to: 

• Making corrections or office information updates

• Adding references to §7. Supporting Information

• Documenting, via a dated attachment, CPG governance agreements (for example, a 

multi-office council that will approve CPGs)

B. In making edits, the office:

• Documents the change in the clearance form FDA 2306 and obtains clearances from 

other affected centers and offices, if any

• Adds a notation in §9. Document History of this SMG

• Does not change this SMG’s effective date

• Informs non-affected centers and offices of the edits

7. SUPPORTING INFORMATION. 

A. Background.

In 1968, the FDA Bureau of Compliance began issuing compliance policies as 

Administrative Guidelines. In 1972, the responsibility for the Guidelines was assigned the 

Office of the Executive Director of Regional Operations (EDRO). In 1980, the 

Administrative Guidelines were compiled into and replaced by the Compliance Policy 

Guides manual which was referenced in the regulation for advisory opinions. After 

reorganization in 1984, the Office of Regulatory Affairs became responsible for publishing 
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the CPG manual. In 1998, the CPG manual was reorganized in current chapters and sections, 

replacing previous numbering system based on the FDA SMGs. In 2000, the agency 

published the final rule for good guidance practices and subsequently determined 

applicability to CPGs.

B. References.

1. 21 CFR 10.85, Advisory opinions 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=10.85 

2. 21 CFR 10.115, Good guidance practices

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=10.115

3. Clearance Record, FDA 2306

https://www.fda.gov/media/145710/download

4. FDA SMG 3280.2, FDA Program Directives System

https://www.fda.gov/media/81730/download

5. FDA external web page containing CPG Revision/Update information and links to CPG 

chapter lists: “Manual of Compliance Policy Guides” 

http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/default.htm.

NOTE: FDA staff will find additional resources for contacts and guidance procedures on the 

FDA intranet “CPG/CPGM Resources” page (see intranet - Policies & Procedures -

Guidance & Regulations).

C. Definitions.

1. Collaborating office – FDA office that works with the originating office to develop, 

review, and clear the content of a CPG and any accompanying FR notice. ORA is a 

collaborating office; OCC may be a collaborating office. Other collaborating offices may 

be in the same or different centers or super-offices as the originating office.

2. Compliance Policy Guide (CPG) – A statement of agency compliance policy to FDA staff 

that provides interpretation of FDA statutory or regulatory requirements.

3. Correction – Typographical, grammar, numbering, formatting, or similar errors, and 

changes such as those resulting from reorganizations (for example, renaming of offices or 

divisions), and relocations (for example, new addresses or phone numbers); a limited 

revision that does affect content of the CPG.

4. Draft CPG – Draft guidance with a specific public comment period according to GGPs; a 

Draft CPG is not incorporated into the CPG manual.

5. Final CPG – Final guidance incorporated into the CPG manual.

6. Issue – Providing a Draft or Final CPG to the public via electronic means.

7. Originating office – FDA office with functional responsibilities for regulatory programs

that leads the development of a new or revised CPG or a CPG withdrawal in that program 

area.
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8. Program – Commodity area, such as human and animal food, human and animal 

pharmaceuticals, biologics, devices and radiological health, and tobacco or other areas 

such as bioresearch monitoring (BIMO).

9. Revision – Action to change a CPG.

10. Withdrawal – Action to remove a CPG from the CPG manual.

8. EFFECTIVE DATE.

07/01/2016

• Originating offices format new CPGs—those initiated after the effective date of this 

SMG—according to the requirements of this SMG and FDA guidance procedures.

• Originating offices reformat existing CPGs according to requirements of this SMG and 

FDA guidance practices when revising the CPG.

9. DOCUMENT HISTORY. SMG 7100.0, Management of the FDA Compliance Policy

Guides Manual

STATUS

(Initial, Revision, 

Cancel)

DATE 

APPROVED

LOCATION OF 

CHANGE HISTORY CONTACT APPROVING OFFICIALS

Initial 6/20/2016 Transmittal ORA Ofc. of Policy and 

Risk Management 

Kate Bent, Assistant 

Commissioner for 

Compliance Policy 
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SMG 7100

ATTACHMENT A – CPG Format and Content

The format for Draft and Final CPGs must be consistent with agency templates for guidance

documents. The CPG/CPGM Resource intranet page contains, as available, links to guidance 

templates. Include the following CPG-specific content information in addition to the standard 

guidance content.

A. Title areas: 

The Draft or Final CPG is identified as follows 

“Compliance Policy Guide 

CPG Sec. [Instruction: Insert CPG number, if available, and title]”

and

“Guidance for FDA Staff”

B. Sections 

I. Introduction: 

The purpose of this Compliance Policy Guide is to provide guidance to FDA staff on. . . [Add

information on the CPG topic, including whom or what the guidance does not address if applicable; if this is a 

revision of a previously issued final CPG, explain briefly how the revised CPG differs from the previous version

(do not duplicate information on policy changes to be supplied in the Background.]

[At the end of the Introduction, include standard guidance language from approved template related to the 

standing of a guidance document, such as not legally enforceable ; describes current thinking; use of the word 

‘should.’]

II. Background: 

[Add background relating to the compliance policy established in the CPG. For example, provide information 

about the problem or situation associated with the policy. If the compliance policy was previously stated in a 

publicly available document, cite that source. When the CPG changes an existing policy, indicate the superseded 

policy and the reason for the change.] 

III. Policy: 

[Include a clear and concise statement of the current FDA compliance policy and the limitations or exceptions, if 

any, to that policy.]

IV. Regulatory Action Guidance:

[Provide guidance to FDA staff on application of the compliance policy for making regulatory decisions relating to 

domestic products and products offered for import. Include criteria for direct reference authority, when applicable

(see the FDA Regulatory Procedures Manual for information on direct reference).]

V. Specimen Charges (as appropriate):

[As appropriate to the subject matter, add specimen charges for the domestic and import violations associated 

with the compliance policy see the Regulatory Procedures Manual, Exhibit 5.3 and Chapter 9 for examples).]

Domestic Seizure: [State the applicable adulteration, misbranding, or other charge. Use an example of the 

language that should be used for stating the applicable violation of the FD&C Act in the U. S. Attorney seizure 

referral letter. If product seizure is not recommended, provide an explanation or alternative action.]

Import Refusal: [State the violation of section 801 or other applicable section of the FD&C Act. Use example 

language that provides the applicable violation of the FD&C Act that should be referenced in OASIS.]

C. Document history
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[At the end of the CPG text, add the applicable issued or revised date of the Final CPG in either mm/yyyy or 

mm/dd/yyy format, for example:

Issued: 10/2001

Revised: 08/2007 (format), 04/2009

Retain earlier issued and revised dates when adding new changes. Use the date corresponding to either the FR

date, or the internet posting date if no FR notice is used.]

[end Attachment A]