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November 17, 2017 Webinar
SOFTWARE PRE-CERT PILOT PROGRAM 

STATUS UPDATE WEBINAR

Digital Health

www.fda.gov
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Topics covered at Kickoff Meetings

• Pre-Cert Pilot Goals and Objectives 

• FDA Perspective

• Pre-Cert Pilot Program Logistics

– Points of Contact

– Engagement Plan and Schedule

• Site Visits and Data Collection: Excellence Principles and 

Common Validating Perspectives

• Questions and Discussions 

www.fda.gov
www.fda.gov

FDA Pre-Cert Pilot Overview

A company-based, streamlined regulatory approach for 

Software as a Medical Device that relies on a demonstrated 

Culture of Quality and Organizational Excellence 
www.fda.gov

• Enable “patient centered” public 

health as digitization touches every 

aspect of healthcare.

• Foster trust in innovative 

technologies as an enabler of a 

new healthcare paradigm.

• Partner with customers to be 

"digital-future ready”. 

CDRH 

Objectives
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An agile and learning regulatory paradigm that is:

CDRH: Envisioning a New DH Paradigm

www.fda.gov

Aligned with 

software 

development 

timelines

Aligned with 

industry 

practices

Aligned with 

global regulators
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FDA Pre-Cert Concept

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
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Pre-Cert Program Objectives

1. Enables a modern and efficient regulatory framework that allows software 

iterations and changes to occur in a timely fashion;

2. Is an easy to follow process for obtaining FDA Pre-Cert and is easily maintained 

by the FDA and industry;

3. Ensures high quality and safe and effective software throughout the life of the 

product by enabling companies to demonstrate their embedded culture of 

quality and organization excellence (CQOE);

4. Enables measurement of “Key Performance Indicators” (KPI) independent of 

organization size, deployment strategies, or computing platforms and provides 

credit for what a company is doing “right”; 

5. Enables for scalability, variation and evolution of software development and 

management processes in use today or others that may exist in the future; and

6. Not static -- a program that learns and adapts (i.e., adjusts/tweaks/evolves 

scorecard elements, key dimensions, and measures) based on the effectiveness 

of the program.

www.fda.gov
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FDA: Key Deliverables

Program component Deliverable/Outcomes of Pilot

Pre-certification Framework

Measures to benchmark CQOE elements

Criteria to evaluate measures

Levels of certification correlated to SaMD risk type

Prototype mechanism for companies to collect measures for precertification as part of their business operations

Mechanics for obtaining and maintaining certification

Regulatory Pathway

Decision Criteria

Develop criteria using IMDRF SaMD risk framework and levels of 

certification

Develop and test mechanism/tools for pathway determination

Processes for Streamlined 

Regulatory Review

Explore optimal review method and content

Explore options for review method content to Pre-Cert status

Post-Market Evidence 

Collection

Identify use scenarios and collection scope and methods

Program Feedback and 

Evaluation

Identify appropriate Pre-Cert program metrics and KPIs to measure 

effectiveness of the program

www.fda.gov
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From Concept to A Program: An Iterative Approach

www.fda.gov

Organizational Excellence Streamlined Review Real world Data Collection

Public meeting 

January 2018

Program proof of 

concept

Late 2018

Pilot Start

Sept 2017

Areas of Focus During Concept Development
www.fda.gov

FDA Pre-Cert Pilot 

Engagement
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FDA Team Structure & Governance

POC Key Responsibilities:

• Serves as primary liaison between Pilot 

Participants and FDA Tactical Team

• Facilitates site visit, including exchange 

of information prior to and following 

visit

• Leads review and analysis of companyprovided data, including synthesis and 

aggregation for purposes of public 

presentation or disclosure

www.fda.gov

FDA Site Visit Team 

(5-7 Members)

1. Bakul Patel, Associate Director, 

Digital Health

2. Point of Contact - Marisa Cruz/ 

Cathy Bahr/John Murray 

3. Pre-Market office

4. Post-Market Surveillance

5. Compliance

6. Entrepreneur-in-Residence
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Pilot Participant Engagement Plan

Activity Topic Lead Outcomes

Kick-Off Meeting FDA  Set frequency of engagement

 Review product roadmap

 Assign FDA POC for PP

CQOE Collection Plan FDA + PP  Review of PP CQOE measures

 Set agenda for site visit

CQOE Collection PP  Collect CQOE measures

 Establish mechanism for data sharing

Consolidate CQOE Measures FDA + PP  Aggregate and normalize CQOE measures across PP 

**

Update CQOE / KPI FDA + PP  Update Pre-Certification Framework **

Determine Pre-Cert Status FDA  Establish Pre-Cert status

Public Meeting FDA + PP  Set agenda for public meeting

 Determine findings to be shared at public meeting **

Product Review Plan FDA + PP  Product categorization

 Set post-market data collection plan **

Product Review FDA + PP  Product review

Pilot Participant Debrief FDA + PP  Aggregate lessons learned **

 Refine CQOE measures **

 Refine product review pathway

** opportunities to share publicly 
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Staged Area of Focus

www.fda.gov
www.fda.gov

Pre-Certification Framework: 

Principles of Excellence
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Excellence Principles

Proactive 

Culture

Cybersecurity 

Responsibility

Clinical 

Responsibility

Product Quality

Patient Safety

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.
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Company Specific –

Common Validating Perspectives

www.fda.gov

Excellence 

Principle

Organizational

Resource Perspective 

How do we empower 

employees to meet the 

excellence principle by 

providing necessary tools, 

training, and infrastructure?

Learning and Growth 

Perspective

How will we employ 

continuous learning and 

improvement to support our 

commitment to the 

excellence principle?

Customer Perspective

How does our consideration 

of customer needs and 

customer satisfaction support 

our commitment to the 

excellence principle?

Process Perspective

How do we ensure our 

processes support our 

commitment to the 

excellence principle?
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Scorecard Framework

www.fda.gov

Patient 

Safety

Cyber 

Responsible

Clinically 

Responsible

Product 

Quality Proactive

Excellence Principles Common Validating 

Perspectives

Library of 

qualitative and 

quantitative 

measures that 

evaluate 

excellence

Process Perspective

How do we ensure our 

processes support our 

commitment to the 

excellence principle?

Organizational

Resource Perspective 

How do we empower 

employees to meet the 

excellence principle by 

providing necessary tools, 

training, and infrastructure?

Customer 

Perspective

How does our consideration 

of customer needs and 

customer satisfaction 

support our commitment to 

the excellence principle?

Learning and Growth 

Perspective

How will we employ 

continuous learning and 

improvement to support our 

commitment to the 

excellence principle?

Key Performance 

Indicators
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Bridging to KPIs: Appraisal Questions

EP CVP Appraisal Questions KPI Patient Safety

Organizational

Resource

How do employees identify, report, and act on 

patient safety issues?

Customer Does your organization contact your customers 

regarding patient safety issues?

Learning and 

Growth

How does your organization identify future 

development or skills needs with regards to patient 

safety?

Process How does your organization validate corrective 

actions to prevent patient safety issues and inform 

patients/customers about potential issues?
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Bridging to KPIs: Appraisal Questions

EP CVP Appraisal Questions KPI Product Quality

Organizational

Resource

What tools do employees have available to identify 

and track product quality issues?

Customer How does your organization monitor customer 

reports of product quality issues?

Learning and 

Growth

How do you leverage real-world evidence in 

improving product quality?

Process How are quality risks in marketed products 

identified and managed? 
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Bridging to KPIs: Appraisal Questions

EP CVP Appraisal Questions KPI Clinical Responsibility

Organizational

Resource

How do you ensure that employees responsible for 

clinical evaluation have the knowledge, skills, and 

experience to understand clinical benefits and risks?

Customer How does your organization incorporate customer 

perspectives into product development and 

modification?

Learning and 

Growth

How does your organization utilize learning from

external sources regarding clinical risks and benefits 

relevant to product design or process 

improvements?

Process How does your organization identify weaknesses or 

gaps in the process of clinical evaluation?
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Bridging to KPIs: Appraisal Questions

EP CVP Appraisal Questions KPI Cybersecurity Responsibility

Organizational

Resource

How is leadership made aware of cybersecurity

issues that arise in product design, development, 

and validation?

Customer How does your organization assess customer needs 

and concerns related to cybersecurity?

Learning and 

Growth

How do employees throughout the organization 

learn about cybersecurity issues?

Process How does your organization monitor process 

optimization and improvement activities for 

cybersecurity?
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Bridging to KPIs: Appraisal Questions

EP CVP Appraisal Questions KPI Proactive Culture

Organizational

Resource

How is the value of operational and product 

improvement efforts measured?

Customer How does your organization communicate with 

customers about new or emerging issues?

Learning and 

Growth

How often are employees rewarded for proactively 

identifying and taking action on opportunities for 

improvement?

Process How are the goals and vision for a proactive 

corporate culture communicated to the 

organization?
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Questions and Considerations

• How would you refine the excellence principles and/or common 

validating perspectives to better reflect your understanding of 

excellence in an organization? How?

• How do you use the common validating perspectives to 

demonstrate commitment to the excellence principles?

• How does your organization use metrics to evaluate your 

performance against these excellence principles? 

www.fda.gov
www.fda.gov

FDA Pre-Cert Pilot Site Visits
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Pre-Cert Site Visit: Objectives

• To experience and understand methods 

and processes for establishing and 

demonstrating a culture of quality and 

organizational excellence.

• Understand current practices.

• Have a clear understanding of how your 

organization approaches and tracks 

progress towards each excellence 

principle. 

• Identify items to enhance the excellence 

framework. 

• The site visit is NOT an 

audit or inspection.

• FDA and company will 

collaborate and be in a 

learning mode to 

refine the framework. 

Key Points
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Pre-Cert Site Visit: Inputs

• Modifications and/or additions to excellence principles and 

common validating perspectives.

• Processes and measures used within the organization that align 

to business needs, rather than to traditional regulatory 

requirements.

• Mapping of processes and measures to CQOE (excellence) 

principles and perspectives.
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Measuring Excellence in Your 

Organization
www.fda.gov

Inviting All Stakeholders To 

Provide Input
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Building the Program Together

What FDA is doing

• Providing regular status updates 

on web site

• Holding regular discussion 

webinars

• Hosting public meetings (first 

meeting to be held at end of 

January)

• Supporting a docket to receive 

public input

What all stakeholders can do

• Associations, coalitions, alliances, 

and other common interest 

groups are encouraged to engage 

interested parties 

• Groups should monitor the PreCert status webpage

• Groups should stay engaged and 

collectively provide input to the 

docket

• All stakeholders should 

participate in webinars and public 

meetings
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Questions ?

For questions related to Digital Health, please contact the Digital Health Team: 

fdapre-certpilot@fda.hhs.gov

For general question, please contact the Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

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

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www.fda.gov/CDRHWebinar

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