Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while we register all of today’s 

participants.

If you have not connected to the audio portion of the 

webinar, please do so now:

U.S. Callers Dial: 877-939-8828 

International Callers Dial: 1-517-308-9385 

Conference Number: PWXW7322399

Passcode: 9105668
DIGITAL HEALTH: FDA ACTIVITIES

SOFTWARE PRECERTIFICATION PILOT PROGRAM – DISCUSSION OF PROPOSED FRAMEWORK 

MAY 10, 2018

www.fda.gov
3 

Digital Health Innovation Action Plan

www.fda.gov

Revise regulations for products that are 

not devices post 21st Century Cures 

Building bench strength 

and expertise 

Refine policies & 

provide guidance

An Integrated Approach

Issue guidance conforming to software 

provisions of the 21st Century Cures 

legislation

Build Digital Health Unit with right 

technical expertise

Launch digital health Entrepreneurs-in- Residence program for building the new 

paradigm

Explore new streamlined 

pathway for software

Launch an innovative Software 

Precertification (Pre-Cert) program to 

build a new approach to digital health 

technology, working with our customers 

and leveraging internationally harmonized 

principles for software regulation
4 

Digital Health Innovation Action Plan

www.fda.gov

Withdraw and amend regulations for 

products that are no longer devices based 

on the effect of the 21st Century Cures Act 

on existing digital health policies.

Publish draft Clinical Decision Support 

Software guidance: that delineates the 

clinical decision support software that is no 

longer under FDA’s jurisdiction

Revise regulations for products that are 

not devices post 21st Century Cures Refine policies & 

provide guidance

Issue guidance conforming to software 

provisions of the 21st Century Cures 

legislation

Publish draft guidance: Effect of the 21st 

Century Cures Act on existing digital health 

policies.

Publish final guidance: Design 

considerations and premarket submission 

recommendations for interoperable 

medical devices.

Publish final guidance: Deciding when to 

submit a 510(k) for a software change to 

an existing device. 

Finalize the International Medical Device 

Regulators Forum approach to clinically 

evaluating Software as a medical device 

(SaMD). 

Publish draft guidance: FDA review of 

products with some software functions 

that are devices and some functions that 

are not.

2017 

2018 

2017 
5 

Multiple Functionality Draft Guidance

Function: Premarket Oversight Postmarket Oversight

Device function under review (510(k), 

PMA, IDE, De Novo, or HDE) 

Reviewed General control requirements are 

applicable (except for IDE)

Device function that is 510(k) exempt Not reviewed but assessed only for 

impact on the safety and effectiveness of 

the device function-under review

General control requirements are 

applicable

Device function for which no premarket 

review is sought and FDA does not intend 

to enforce applicable regulatory controls

Not reviewed but assessed only for 

impact on the safety and effectiveness of 

the device function-under review

General control requirements are 

applicable but not intended to be 

enforced

Non-device function Not regulated but assessed only for 

impact on the safety and effectiveness of 

the device function-under review

Not regulated and therefore FDA 

requirements not applicable

Key Draft Policy Proposed

(A) Does the other function impact the safety or effectiveness of the device function-under review?; 

and 

(B) Does the impact result in increased risk or have an adverse effect on performance?

www.fda.gov
6 

FDA Pre-Cert Program

An organization-based streamlined regulatory approach

 

for 

Software as a Medical Device (SaMD) 

 

that relies on a demonstrated 

Culture of Quality and Organizational Excellence 

www.fda.gov
7 

Concept: A Reimagined Approach Using FDA Pre-Cert

www.fda.gov

Clinical Trials

Outcomes 

research

Commercial 

Distribution & 

Real-World Use

e.g. lower-risk software, 

certain modifications

Real World 

Data 

Collection 

Based on 

SaMD Risk + 

Pre-Cert level Streamlined 

Premarket 

Review

FDA Pre-Cert 

level 
8 

Developing the Program with Stakeholder Input

www.fda.gov
9 

April Program Update

www.fda.gov
10

Four Key Program Components in Proposed 

Framework 

www.fda.gov

Streamlined 

Premarket Review

Streamlined 

Review

Risk Based 

(SaMD Risk + 

Pre-Cert level)

Review 

Determination

FDA Pre-Cert 

Level 1

FDA Pre-Cert 

Level 2

Excellence Appraisal 

and Certification 

Real-World 

Performance

Real world 

Program 

Performance

Real world 

SaMD 

Performance
11

Five Excellence Principles Proposed

Demonstration of a commitment to providing a safe patient

experience, and to emphasizing patient safety as a critical factor 

in all decision-making processes. 

Demonstration of a commitment to the development, testing, 

and maintenance necessary to deliver SaMD products at the 

highest level of quality. 

Demonstration of a commitment to responsibly conduct clinical 

evaluation and to ensure that patient-centric issues including 

labeling and human factors are appropriately addressed. 

Demonstration of a commitment to protect cybersecurity, and 

to proactively address cybersecurity issues through active 

engagement with stakeholders and peers.

Demonstration of a commitment to a proactive approach to 

surveillance, assessment of user needs, and continuous learning.

Patient 

Safety 

Product Quality

Clinical 

Responsibility 

Cybersecurity 

Responsibility 

Proactive 

Culture

www.fda.gov
12

Eligibility Application Appraisal Determination Maintenance

Concept in the Working Model v0.1 – April 2018 • Any 

organization 

that intends to 

develop or 

market a 

regulated SaMD 

in the United 

States.

• FDA anticipates 

precertification 

at a business 

unit or center of 

excellence level, 

rather than at a 

corporate level.

Eligible 

organizations or 

business units 

apply.

FDA confirms 

eligibility and 

acceptability.

FDA and applicant 

initiate process for 

precertification 

determination.

• Applicant 

collects 

objective 

indicators 

related to the 

excellence 

principles.

• Collected 

information 

demonstrating 

capabilities and 

maturity made 

available for 

appraisal.

• FDA evaluates 

evidence and 

decides on 

approval and 

level of 

precertification.

• Automated 

tracking and 

monitoring of 

adherence to 

excellence 

principles.

• Proactive 

response to 

postmarket 

indicators.

• Details to be 

developed in 

future version.

Excellence appraisal and precertification

Scope of the component: The process for organization level 

precertification, including eligibility and application, evaluation against 

precertification criteria, and precertification status determination.

www.fda.gov
13

Challenge Question 1.1 Excellence appraisal and 

precertification

How might an existing excellence or maturity appraisal framework used by an organization 

be leveraged to demonstrate the organization’s performance and success as outlined by the 

five excellence principles?

How should the FDA take into consideration...

• Certifications granted by external business excellence appraisal entities

• Maturity assessments made by external agencies

• Use of standards

• Accreditations

• Adoption of corporate level policies at a business unit level

• Adapting the appraisal model for start-up, new businesses

• Other... 

www.fda.gov
14

Provide ongoing input through the public docket

Send questions about the program

FDAPre-CertPilot@fda.hhs.gov

Look for ongoing program updates

bit.ly/Precertupdates

bit.ly/docketjan18

How You Can Get Involved

www.fda.gov
15

Review Determination

1. Working to refine the SaMD International Medical Device Regulators Forum 

(IMDRF) Risk framework for application in the precertification program.

2. Preliminarily based on the risk category of SaMD product, determine when 

premarket review is necessary, including initial product availability, and major 

and minor product changes informed by: 

– Organization’s Pre-Cert status and level (Excellence Appraisal)

– SaMD premarket requirements (Streamlined Review)

– SaMD postmarket requirements (Real-World Performance)

Scope of the component: The process and expectations for pre-certified 

organizations to determine when streamlined premarket review is

applicable for each category of SaMD products. 

www.fda.gov

Concept in the Working Model v0.1 – April 2018
16

Challenge Question 2.2: Review Determination

We are exploring the refinement of the “IMDRF definition statement,” which is intended to provide a structured 

way in describing intended use for SaMD. 

The IMDRF framework highlights the following components:

– The significance of the information provided by the SaMD to the healthcare decision; more specifically, 

how the SaMD dictates treatment or diagnosis, drives clinical management, or informs clinical 

management;

– The state of the healthcare situation or condition that the SaMD is intended for; more specifically, a 

description of the health state when the SaMD is intended for use, ranging from critical to serious to nonserious; and

– A description of the SaMD core functionality; more specifically, the critical features of the SaMD that are 

essential to the intended significance of the information provided by the SaMD to the healthcare decision 

in the intended healthcare situation or condition.

• Within each of the three components, are there other factors that are currently included in describing the 

products’ intended use, and if so, what? 

• Should the factors in the current components be further refined in order to provide clarity around the 

function and intended use of the SaMD and if so, how?

Questions...

www.fda.gov
17

Provide ongoing input through the public docket

Send questions about the program

FDAPre-CertPilot@fda.hhs.gov

Look for ongoing program updates

bit.ly/Precertupdates

bit.ly/docketjan18

How You Can Get Involved

www.fda.gov
18

Streamline Review

Scope of the component: The process and expectation for a precertified

organization and the FDA when it is determined that a streamlined 

premarket review is necessary to reasonably assure safety and 

effectiveness of a SaMD. 

Goals

• Identify information necessary to reasonably assure safety and effectiveness 

to be reviewed

• Identify aspects that will be relied upon during pre-certification appraisal and 

the organizations engagement in real world performance data monitoring of 

their SaMD

• Identify an interactive process of conducting the review that yields best 

experience for FDA reviewers and organizations participating in the program

www.fda.gov

Concept in the Working Model v0.1 – April 2018
19

Challenge Question 3.1 Streamline Review

Given that one goal of this program is to significantly reduce the average premarket review timeline, what 

would be the best way for pre-certified companies to share product review information with us? Specifically:

Questions...

• What specific elements of review could be shifted to the company-specific excellence appraisal (as opposed to the 

product-specific review)?

• What are the features of a SaMD product that need to be assessed during device review?

• What product-specific content would be expected to be reviewed premarket?

• What specific postmarket real world data could be collected to support the assurance of safety and effectiveness 

for each product if an element is not reviewed premarket?

• What updates would FDA require, and at what interval, to provide continuous assurance of safety and 

effectiveness?

• Should there be a phased market authorization, where some elements are reviewed premarket and other 

elements are gathered through real world evidence to support full market authorization? What should happen to 

products that receive “preliminary” market authorization but fail to provide adequate evidence in the agreed upon 

timeframe?

www.fda.gov
20

Provide ongoing input through the public docket

Send questions about the program

FDAPre-CertPilot@fda.hhs.gov

Look for ongoing program updates

bit.ly/Precertupdates

bit.ly/docketjan18

How You Can Get Involved

www.fda.gov
21

Real-World Performance

Scope of the component: The process for developing real-world 

performance data (RWPD) elements and analytic methodologies needed 

for Pre-Cert Program activities. 

Preliminary Pre-Cert Program Feedback: Use of aggregate organizational RWPD 

analysis as feedback to EA and SR components of the Pre-Cert Program

Preliminary Inputs to Initial Precertification: Use of aggregate product RWPD as 

inputs into initial precertification

Preliminary Inputs to Maintenance of Precertification: Use of aggregate product-level 

RWPD analysis as inputs into maintenance or modification of precertification status 

Preliminary Post-launch Product Monitoring: Post-launch monitoring of RWPD to 

ensure ongoing safety and effectiveness of a SaMD product

Preliminary Product Claim Modifications: Use of RWPD in making and modifying SaMD

product claims

Program Level

Organization 

Level 

Product Level

www.fda.gov

Concept in the Working Model v0.1 – April 2018
22

Challenge Question 4.4 Real-World Performance

Are the definitions for data types underlying RWPD accurate and 

comprehensive? Do the terms used in this section need to be modified or 

revised?

www.fda.gov
23

Questions & Answers

www.fda.gov
24

2018 2019

Pre-Cert Program Roadmap

Jan Dec

Dec

Jan

Pre-Cert 

2.0

Pre-Cert 1.x

Dec

Build - Test - Iterate Integrate Pre-launch Launch

Pre-Cert 

1.0

www.fda.gov
25

Provide ongoing input through the public docket

Send questions about the program

FDAPre-CertPilot@fda.hhs.gov

Look for ongoing program updates

bit.ly/Precertupdates

bit.ly/docketjan18

Keep Engaging With Us

www.fda.gov
26

Survey Available

Slide Presentation, Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under the Heading: Specialty Technical Topics; Subheading: IT and Software

Please complete a short survey about your FDA CDRH webinar experience. The survey can 

be found at www.fda.gov/CDRHWebinar

 immediately following the conclusion of the live webinar.