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Today’s Topic:

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial 

Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, Draft Guidance

April 13, 2023
Marketing Submission Recommendations for a Predetermined Change Control Plan for 

Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, 

Draft Guidance 

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Catherine Bahr

Assistant Director

Emerging Technology Assessment and 

Strategy

Digital Health Center of Excellence

Office of Strategic Partnerships and 

Technology Innovation

Matthew Diamond, MD, PhD

Chief Medical Officer

Digital Health Center of Excellence

Office of Strategic Partnerships and 

Technology Innovation

B.Y. MiRa Jacobs, PhD

Biomedical Engineer

Policy Leadership and Development

Digital Health Center of Excellence

Office of Strategic Partnerships and 

Technology Innovation
3

Matthew Diamond, MD, PhD

Chief Medical Officer

Digital Health Center of Excellence

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Draft Guidance

• Marketing Submission Recommendations for a 

Predetermined Change Control Plan for Artificial 

Intelligence/Machine Learning (AI/ML)-Enabled 

Device Software Functions

www.fda.gov/regulatory-information/search-fda-guidance-documents/marketingsubmission-recommendations-predetermined-change-control-plan-artificial

4
Learning 

Objectives

 Describe background on FDA’s collaborative patientcentered approach to AI/ML-enabled devices

 Describe purpose and scope of draft guidance

 Explain FDA’s current thinking on modifications for

Machine Learning-Enabled Device Software Functions

(ML-DSFs)

 Describe the proposed recommendations for

information to be included in a Predetermined Change

Control Plan (PCCP) in a marketing submission for a

device that is or includes an ML-DSF

5
Background

6
Patients are at the Heart of What We Do

CDRH Vision

Patients in the U.S. have access to high-quality, safe, and effective 

medical devices of public health importance first in the world 

7
Ensuring Patient Access to Safe and Effective 

AI/ML-Enabled Devices

• Digital health technologies play an increasingly significant role in many facets of our health and 

daily lives, across a broad spectrum of diseases and conditions

• AI/ML is powering important advancements in this field in a manner that lends itself to rapid 

technological improvement over time

• Ensuring these innovative devices are safe, effective, and can reach their full potential to help 

people, is central to the FDA’s public health mission

8
Promoting Development of Safe and Effective

AI/ML-Enabled Devices

The draft guidance:

• Proposes a science-based approach to put safe and 

effective advancements in hands of health care 

providers and users faster

– Help to enable more personalized medicine and 

increase pace of medical device innovation 

– Informed by FDA’s experience in regulating AI/MLenabled devices

9
• PCCPs can further this priority by:

– Facilitating more rapid and continuous improvement of

AI/ML-enabled device performance across diverse

populations

– Ensuring important performance considerations –

including with respect to race, ethnicity, disease severity,

gender, age, and geographical considerations – are

addressed throughout the total product lifecycle

• Draft guidance proposes to place a significant and

increased emphasis on importance of clearly

communicating valuable information about these

considerations to device users

10

Supporting FDA’s Strategic Priority

to Promote Health Equity
FDA’s Collaborative Patient-Centered Approach

to AI/ML-Enabled Devices

Public Workshop on 

Transparency of AI/ML Devices

WORKSHOP

Transparency of 

AI/ML-Enabled 

Medical Devices October 14,, 2021

Contributed to IMDRF’s 

Key Terms and Definitions

Public Workshop on 

AI/ML in Radiological 

Imaging

WORKSHOP

Evolving Role of 

AI in Radiological 

Imaging February 28-28, 2020

We're working collaboratively with stakeholders to build a proactive, patient-centered approach to 

AI/ML-enabled devices that promotes health equity.

2019 2020 2021

Published AI/MLSaMD Discussion 

Paper

First joined Collaborative 

Community related to AI/ML

PEAC Mtg on Patient 

Trust in AI/ML Devices

Published AI/ML Medical 

Device Software Action Plan 

Posted List of Currently 

Marketed AI/ML Devices

Published GMLP

Guiding Principles

2022

Published Final Guidance: 

Clinical Decision Support

FINAL GUIDANCE

Clinical Decision 

Support (CDS) Software

2023

DRAFT GUIDANCE

Marketing Submission 

Recommendations for 

Predetermined Change Control Plan

AI/ML

Guidance

11
FDA’s Collaborative Patient-Centered Approach

to AI/ML-Enabled Devices

2019 2021 2023

Discussion Paper Action Plan Draft Guidance

Holistic, patient-centered strategic 

approach to AI/ML-enabled devices that 

promotes health equity, including aims to 

update the proposed regulatory 

framework and foster a patient-centered 

approach, including transparency to 

users

Proposed regulatory framework for 

modifications to AI/ML-enabled medical 

device software to assure their safety 

and effectiveness, including prespecification of software changes to 

enable rapid improvement of software 

products

Proposed, least burdensome 

approach to support safe, iterative 

improvement through modifications to 

an AI/ML-enabled device

12
Food and Drug Omnibus Reform Act (“FDORA”) 

Included a Provision for PCCPs

FDORA grants authority for PCCPs*

• Changes to a device consistent with an approved predetermined change control plan do not require a 

supplemental application. It may also require that change control plans include labeling required for safe 

and effective use of the device.

• This Draft Guidance provides proposed recommendations specifically for MLDSFs that a manufacturer intends to modify over time. Consistent with the 

addition of section 515C, this draft guidance discusses the submission of PCCPs in 

marketing submissions for ML-DSFs.

The PCCP provision applies to more than just AI/ML-enabled devices

• This provision applies to all devices—it is not specific to AI/ML-enabled devices or software devices. It 

applies to both premarket approval (PMA) applications and 510(k) applications. 

2023 Draft Guidance on PCCPs for AI/ML-Enabled Devices

13

*Per section 3308 of FDORA, Title III of Division FF of the Consolidated Appropriations Act, 2023, enacted on December 29, 2022, which 

added section 515C to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Purpose and Scope

14
Scope of Draft Guidance

• Applicable to machine learning-enabled device software functions (MLDSFs) that a manufacturer intends to modify over time

• Describes proposed recommendations on information to be included in a 

Predetermined Change Control Plan (PCCP) provided as part of a marketing 

submission 

• Generally, recommendations apply to device constituent part of a 

combination product, when the device constituent part is (or includes) an 

ML-DSF

• PCCP is an optional mechanism within a marketing submission for 

premarket authorization for modifications to an ML-DSF

15
Scope of Draft Guidance

• NOT intended to provide a complete description of what may be necessary 

to include in a marketing submission for an ML-DSF

• NOT intended to delineate types of modifications the Agency would consider 

acceptable in a PCCP

• FDA Review Team determines whether scope of modifications is appropriate 

for inclusion in a PCCP and what evidence and information are required to 

support proposed modifications in a marketing submission

16
Pathways for Authorization

• FDA considers the PCCP to be part of the technological characteristics 

of the device

• Per section 515C of the FD&C Act, a PCCP may be reviewed in a 510(k) 

if the device remains:

– safe and effective without any such change

– substantially equivalent to the predicate

• Per section 515C of the FD&C Act, only the version of an ML-DSF that 

has been cleared or approved, prior to implementing any changes 

made per an authorized PCCP, may be used as a predicate device

17
18

B.Y. MiRa Jacobs, PhD

Biomedical Engineer

Policy Leadership and Development

Digital Health Center of Excellence

Center for Devices and Radiological Health

U.S. Food and Drug Administration
• Device Software Function (DSF): 

Software function that meets the device definition in section 

201(h) of the FD&C Act. As discussed in other FDA guidances, the 

term “function” is a distinct purpose of the product, which could be 

the intended use or a subset of the intended use of the product

• Machine Learning-Enabled Device Software Function (ML-DSF): 

A device software function (as defined above) that implements an 

ML model trained with ML techniques

19

Definitions
Definitions – Data Sets

• Training Data: These data are used by the ML-DSF manufacturer in 

procedures and ML training algorithms to build an ML model, including to 

define model weights, connections, and components 

• Tuning Data*: These data are typically used by the ML-DSF manufacturer to 

evaluate a small number of trained ML-DSFs in order to explore, for example 

different architectures or hyperparameters 

• Testing Data: These data are used to characterize the performance of the 

ML-DSF. The testing phase is expected to provide data to establish a 

reasonable assurance of safety and effectiveness before an ML-DSF is 

marketed 

20

*The ML community sometimes refers to the tuning data and phase with the word “validation.” To be consistent with the definition of 

validation in 21 CFR 820.3(z), we recommend that the word “validation” not be used when referring to data or operations related to 

training or tuning ML models intended for medical applications.
• Predetermined Change Control Plan (PCCP):

Documentation describing what modifications will be made to the ML-DSF and how 

the modifications will be assessed. Includes:

– Description of Modifications

– Modification Protocol

– Impact Assessment

• Authorized Predetermined Change Control Plan:

A PCCP that has been reviewed and established through a device marketing 

authorization. An authorized PCCP is a technological characteristic of the authorized 

device with which it was established 

21

Definitions –

Predetermined Change Control Plan
Term Mapping

Predetermined Change 

Control Plan

SaMD Pre-Specifications

Algorithm Change Protocol

Impact

Predetermined Change 

Control Plan

Description of Modifications

Modification Protocol

Impact Assessment

2019 Discussion Paper Current Draft Guidance

SaMD = Software as a Medical Device 22
Draft Guidance Document Outline

• Intro, Background, Scope

• Definitions

• Policy for PCCP

• Description of Modifications

• Modification Protocol

• Impact Assessment

• Appendix A: Example Elements of 

Modification Protocol Components

• Appendix B: Example ML-DSF 

Scenarios Employing PCCPs

23
Proposed Approach for Modifications 

for Machine Learning-Enabled Device 

Software Functions

(ML-DSF)

24
Draft Policy for PCCPs

An authorized PCCP 

specifies planned 

modifications that, if 

not included in a 

PCCP, could 

otherwise require a 

new marketing 

submission*

The modifications 

can be implemented 

to the ML-DSF 

without triggering 

the need for a new 

marketing 

submission

Modifications made 

to an ML-DSF that are 

not specified in the 

authorized PCCP 

could require a new 

marketing 

submission*

25

*Note: pursuant to 21 CFR 807.81(a)(3) and 21 CFR 814.39(a), and in accordance with the “Modifications” guidances. For a 

list of the “Modifications” guidances, please see the Resources slide.
Proposed Components of PCCPs

Description of 

Modifications

Modification 

Protocol

Impact 

Assessment

“What” a manufacturer intends the algorithm to become as it learns

“How” the algorithm will learn/change while remaining safe and effective

Describes modifications’ benefits and risks, and how risks are mitigated

Predetermined Change Control Plan

• Identifies specific, planned modifications to ML-DSF 

that the manufacturer intends to implement

• Draws a “range of FDA-authorized specifications” 

around initial device characteristics and 

performance

• Describes methods that will be followed when 

developing, validating, and implementing the 

modifications to ensure the device remains safe and 

effective

• Methods described in Modification Protocol should 

be consistent with and support the modifications 

outlined in Description of Modifications

• Assesses benefits and risks of each individual 

modification, as well as collective impact of 

modifications, included in the Description of 

Modifications

• Discusses how activities proposed within 

Modification Protocol mitigate identified risks to 

continue to reasonably ensure the safety and 

effectiveness of the device

26
Proposed PCCP Recommendations 

for Marketing Submissions

27
Establishing a PCCP

• A PCCP is included in a marketing submission for a device and 

established as part of that authorization*

• An “authorized PCCP” is one that has been reviewed and 

established through the device marketing authorization

• To establish a new PCCP for a previously authorized device, the 

marketing submission must include appropriate marketing 

submission requirements and the proposed PCCP for the device

*Note: The term “authorization” is used to include clearance of a 510(k), granting of a De Novo, or approval of PMA

28
Identifying a PCCP in a Marketing Submission

• In the marketing submission, the PCCP:

– should be a standalone section, noted in the cover letter, and listed in the table of contents as 

“Predetermined Change Control Plan” 

– should be discussed as part of the device description, labeling, and other relevant sections

• The PCCP should be described in the:

– 510(k) summary, 

– De Novo decision summary, or

– PMA summary of safety and effectiveness document (SSED) and approval order 

• Details of the PCCP should be included in sufficient detail to support transparency to 

users regarding the safety and effectiveness of the device

• Labeling should include an adequate description to ensure appropriate use of the 

device

29
Using an Authorized PCCP to Implement Modifications

30

Document

in accordance with Quality 

System

No

Submit Marketing 

Submission for 

the modification*

Yes

Is the modification

(1) specified in the Description of 

Modifications

and

(2) implemented in conformance with 

the methods and specifications in the 

Modification Protocol 

of an authorized PCCP?

Following review of the 

applicable laws and regulations, 

is a new marketing submission 

required?

START Yes

No

*For the modified device to have a PCCP, a PCCP should be submitted with the 

marketing submission so that the device and PCCP can be authorized together.
Using an Authorized PCCP to Implement Modifications

31
Using an Authorized PCCP to Implement Modifications

32
Using an Authorized PCCP to Implement Modifications

Document

in accordance with Quality 

System

No

Submit Marketing 

Submission for 

the modification*

Yes

Is the modification

(1) specified in the Description of 

Modifications

and

(2) implemented in conformance with 

the methods and specifications in the 

Modification Protocol 

of an authorized PCCP?

Following review of the 

applicable laws and regulations, 

is a new marketing submission 

required?

START Yes

No 33
Using an Authorized PCCP to Implement Modifications

34
Using an Authorized PCCP to Implement Modifications

35
Using an Authorized PCCP to Implement Modifications

36

Document

in accordance with Quality 

System

No

Submit Marketing 

Submission for 

the modification*

Yes

Is the modification

(1) specified in the Description of 

Modifications

and

(2) implemented in conformance with 

the Modification Protocol 

of an authorized PCCP?

Following review of the 

applicable laws and regulations, 

is a new marketing submission 

required?

START Yes

No

*For the modified device to have a PCCP, a PCCP should be submitted with the 

marketing submission so that the device and PCCP can be authorized together.
Modifications that are not consistent with 

an Authorized PCCP

• The manufacturer should evaluate modifications to an authorized device that 

are not consistent with an authorized PCCP to determine if a new marketing 

submission is required for the modification, as would modifications to a 

device without an authorized PCCP 

– For 510(k), see 21 CFR 807.81(a)(3)

– For PMA, see 21 CFR 814.39(a)

• If, after review of applicable laws and regulations, a new marketing 

submission is required, then the manufacturer must submit the appropriate 

marketing submission before the modified device is marketed 

37
Modifying a Device and its PCCP

An authorized PCCP is applicable only to the version of the authorized device with which it was 

established

• To modify a PCCP for a previously authorized device with a PCCP, the 

marketing submission must include the appropriate marketing submission 

requirements for the device and a proposed PCCP

• If the authorized device is significantly modified, except for modifications 

specified in the authorized PCCP, a new marketing submission is required

38
39

Catherine Bahr

Assistant Director

Emerging Technology Assessment and 

Strategy

Digital Health Center of Excellence

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Description of 

Modifications

“What” a manufacturer intends the 

algorithm to become as it learns

Description of Modifications

Modification 

Protocol

Impact 

Assessment

PCCP

40
• Includes a detailed description of each planned modification to an ML-DSF

– All modifications included in a PCCP should maintain the device within the 

device’s Indications for Use (IFU) statement 

• Describes changes to device characteristics and performance resulting from 

implementation of modifications 

– Draws a “range of FDA-authorized specifications” around initial device 

characteristics and performance

• FDA recommends that a PCCP include only a limited number of modifications 

that are specific, and that can be verified and validated

41

Description of Modifications
Recommendations for Modification 

Descriptions

• Identify specific modifications that can be verified and validated

• Present modifications at a level of detail that permits understanding of 

specific changes that will be made to the ML-DSF

• Link each modification to a specific performance evaluation activity within 

the Modification Protocol

• State whether planned modifications will be implemented manually or 

automatically

• Specify if proposed modifications will be implemented globally or locally

– For planned local adaptations, describe what local factors or conditions warrant a local 

change

42
Modifications Appropriate for a PCCP

• Modifications should maintain or improve the safety or 

effectiveness of the device

• Modifications should be able to be verified and validated 

within existing quality system of device

• Modifications should maintain the device within the device’s 

Indications for Use (IFU) statement

• Not all modifications may be appropriate for inclusion within a 

PCCP

43
Types of Modifications for a PCCP

• Modifications related to quantitative measures of ML-DSF performance specifications

– Example: Improvements to analytical and clinical performance resulting from retraining the ML model based on new data within the intended use population from the 

same type and range of input signal

• Modifications related to device inputs to the ML-DSF

– Example: Expanding algorithm to include new sources of same signal type (such as 

different makes, models, or versions of a data acquisition system) or limited 

modifications related to new types of inputs

• Limited modifications related to device’s use and performance

– Example: Authorization of a device for specific subset of a population within originally 

indicated population based on re-training on a larger data set for that subpopulation 

not previously available

44
Description of 

Modifications

Impact 

Assessment

PCCP

“How” the algorithm will learn/change while 

remaining safe and effective

Modification Protocol

45
• Methods described in Modification Protocol should be consistent with and 

support modifications outlined in Description of Modifications

• Four primary components of a Modification Protocol:

(1) data management practices, 

(2) re-training practices, 

(3) performance evaluation protocols, and 

(4) update procedures, including communication and transparency to users and real-world 

monitoring plans 

• Include description of how proposed methods are similar to, or are different 

from, methods used elsewhere in marketing submission

46

Modification Protocol
Elements of a Modification Protocol

(1) Data Management

• Collection Protocols

•Assurance of Data 

Quality

• Reference Standard 

Determination

• Sequestration of 

Data Sets

(2) Re-Training

• Re-training 

Objectives and Focus

• Re-training 

Implementation

(3) Performance 

Evaluation

• Triggers to Initiate 

Performance 

Evaluation

•Assessment Metrics 

and Elements

• Statistical Analysis 

Plans

• Performance Targets

•Additional Testing 

Needs

(4) Update Procedures

• Software Verification 

and Validation

•Update 

Implementation 

(When/How)

• Communication and 

Transparency to 

Users

•Device Monitoring 

Plan

From Appendix A 47
PCCP should clearly delineate which parts of Modification Protocol are applicable 

to each modification within Description of Modifications

Modification Protocol Component

Modification Data management 

practices

Re-training 

practices

Performance 

evaluation Update procedures

Modification #1 Method A 

(see Section X.A)

Method D 

(see Section X.D)

Method G 

(see Section X.G)

Method J 

(see Section X.J)

Modification #2 Method A 

(see Section X.A)

Method E 

(see Section X.E)

Method H 

(see Section X.H)

Method J 

(see Section X.J)

Modification #3 Method B 

(see Section X.B)

Method F 

(see Section X.F)

Method I 

(see Section X.I)

Method J 

(see Section X.J)

Table 1. Example of Description of Modifications to Modification Protocol Traceability Table 

48

Traceability between Modification Protocol

and Description of Modifications
Description of 

Modifications

Modification 

Protocol

PCCP

Describes modifications’ benefits and risks, and 

how risks are mitigated

Impact Assessment

49
Documentation for an Impact Assessment provided to the Agency 

in a marketing submission containing a PCCP should: 

Compare version of 

device with each 

modification 

implemented to version 

of device without any 

modifications 

implemented 

Discuss benefits and 

risks of each individual 

modification

Discuss how activities 

proposed within 

Modification Protocol 

continue to reasonably 

ensure safety and 

effectiveness of device 

Discuss how 

implementation of one 

modification impacts 

implementation of 

another

Discuss collective 

impact of implementing 

all modifications

50

Impact Assessment
51

B.Y. MiRa Jacobs, PhD

Biomedical Engineer

Policy Leadership and Development

Digital Health Center of Excellence

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Examples

52
Example

Device Proposed Modifications Post-Authorization Scenarios

Skin Lesion Analysis Software w/ Authorized PCCP

Device is an ML-DSF that analyzes images of skin lesions by identifying and 

characterizing its features (for example, color, quantification of area change over 

time) to aid in diagnosis. 

Device was validated with a specific camera and is intended to be used by a 

primary healthcare provider. 

53
Example

Device Proposed Modifications Post-Authorization Scenarios

Skin Lesion Analysis Software w/ Authorized PCCP

Manufacturer would like to extend ML-DSF for use on additional general-purpose 

computing platforms, including smartphones and tablets. 

General-purpose computing platform must include a two-dimensional camera that meets 

the minimum specifications defined in the PCCP. 

Updated device must achieve a minimum performance defined in Modification Protocol 

using a specified methodology. 

54
Device Proposed Modifications Post-Authorization Scenarios

Modification in input, as 

specified in PCCP and 

implemented in accordance 

with PCCP

Modification in input 

that was not specified in 

PCCP 

Modification 

Scenario 1

Modification 

Scenario 2

Modification related to 

device’s use and 

performance, which was 

not specified in PCCP

Modification 

Scenario 3

55

Example
Modification Scenario 1

Modification Scenario

Modification in input, as specified in the PCCP and 

implemented in accordance with the PCCP

Because the device modification was 

specified in PCCP, and it was 

implemented in conformance with 

PCCP, device modification would not 

require a new marketing submission

Manufacturer should document 

modification that was specified in PCCP 

in accordance with their quality system

• Analytical validation demonstrated the ML-DSF can be 

deployed on two additional smartphones that meet 

the minimum specifications provided in the PCCP. The 

analytical performance using the new image 

acquisition systems was found to be statistically 

equivalent to the baseline performance

• Labeling was updated to reflect new ML-DSF 

compatibility with additional smartphones and 

communication updates on device compatibility were 

also provided

56
Modification Scenario

Modification in input that was not specified 

in PCCP Because this modification was not 

included in PCCP, and it could 

significantly affect safety or 

effectiveness of the device 

a new marketing submission 

would be required

• Manufacturer would like to deploy a 

modified ML model that uses images 

captured by a thermographic camera

• However, new camera technology was 

not specified in PCCP

57

Modification Scenario 2
Modification Scenario

Modification related to the device’s use and performance, 

which was not specified in the PCCP Because this modification was not 

included in PCCP, and it could 

significantly affect safety or 

effectiveness of the device 

a new marketing submission 

would be required

• Manufacturer would like to distribute a new version of 

the ML-DSF that is patient-facing

• ML-DSF would provide an analysis of physiological 

characteristics of skin lesions, as it does currently, and 

direct patients to follow-up with a dermatologist based 

on the preliminary analysis of the malignancy of the 

skin lesion

• Modification introduces many new, unconsidered risks, 

given that the modified ML-DSF will be patient-facing 

58

Modification Scenario 3
59

Matthew Diamond, MD, PhD

Chief Medical Officer

Digital Health Center of Excellence

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Summary Webinar 

Objectives

This Draft Guidance:

 Describes FDA’s proposed approach to ML-DSFs to 

support their iterative development and improvement 

over time

 Builds on the Agency’s longstanding commitment to 

developing innovative approaches to ensuring safe and 

effective digital health technologies are available to 

patients

 Includes proposed recommendations on information 

to be included in a PCCP provided as part of a 

marketing submission for an ML-DSF 

 Specifies that modifications made to an ML-DSF in 

accordance with an authorized PCCP can be 

implemented to the ML-DSF without a new marketing 

submission 

 Includes details on the proposed recommended 

content of these sections, and additional examples are 

provided in appendices

60
Resources

Slide 

Number

Cited Resource URL

25 Deciding When to Submit a 510(k) 

for a Software Change to an 

Existing Device

www.fda.gov/regulatory-information/search-fda-guidancedocuments/deciding-when-submit-510k-software-changeexisting-device

25 Deciding When to Submit a 510(k) 

for a Change to an Existing Device

www.fda.gov/regulatory-information/search-fda-guidancedocuments/deciding-when-submit-510k-change-existing-device

25 Modifications to Devices Subject 

to Premarket Approval (PMA) 

www.fda.gov/regulatory-information/search-fda-guidancedocuments/modifications-devices-subject-premarket-approvalpma-pma-supplement-decision-making-process

37 21 CFR 807.81(a)(3) www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part807/subpart-E/section-807.81#p-807.81(a)(3)

37 21 CFR 814.39(a) www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part814/subpart-B/section-814.39#p-814.39(a)

61
A Note about Draft Guidance

• You may comment on any guidance at any time

– see 21 CFR 10.115(g)(5)

• Please submit comments on draft guidance before 

closure date

– to ensure that FDA considers your comment on a draft 

guidance before we work on final guidance

62
Submit Comments to Dockets by:

July 03, 2023

• Docket: FDA-2022-D-2628 – www.regulations.gov/docket/FDA-2022-D-2628

• Draft Guidance

– www.fda.gov/regulatory-information/search-fda-guidancedocuments/marketing-submission-recommendations-predeterminedchange-control-plan-artificial

63