1 

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FDA/CDRH Webinar

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Conference Number: PWXW4874924
SOFTWARE PRECERTIFICATION 

PILOT PROGRAM

Digital Health

www.fda.gov
3 

Digitization Across the Health Care 

Continuum

www.fda.gov

Leveraging computing power, sensors, connectivity

and software.

Moving health care from 

the Clinic to the Patient.

Understanding patient’s 

behavior and physiology 

“In the wild”.

Focusing on prevention 

for early/smaller 

interventions. 
www.fda.gov 4 

• Enable “patient centered” public 

health as digitization touches every 

aspect of health care. 

• Foster trust in innovative 

technologies as an enabler of a 

new health care paradigm.

• Partner with customers to be 

"digital-future ready”. 

CDRH 

Objectives 
5 

Smart Regulation Principles

Risk Based 

Functionality 

Focused

Platform 

Independent 

Promote 

Innovation 

Narrowly 

Tailored

Promote 

Patient 

Engagement

Protect 

Patient 

Safety

www.fda.gov
6 

Digital Health Foundational Policies

www.fda.gov

RF Wireless -guidance

Mobile medical app (MMA)

FDASIA Health IT report

Premarket Cybersecurity

MDDS/image storage and communication

General wellness

Accessories

Interoperability

Post-market 

cybersecurity

MMA update
7 

International Convergence on 

Software as a Medical Device (SaMD)

IMDRF goal - a converged SaMD framework and associated controls.

www.fda.gov

A prioritized 

building 

blocks 

strategy
8 

21 Century Cures Act – Codifies FDA Policies

The new law amended the definition of “device” in the Food, 

Drug and Cosmetic Act to exclude certain software functions 

intended... 

• (A) for administrative support;

• (B) for maintaining or encouraging a healthy lifestyle;

• (C) to serve as a electronic patient records;

• (D) for transferring, storing, converting formats, or displaying 

clinical laboratory test or other device data and results and 

certain other related information; and

• (E) to provide recommendations to health care professionals 

for clinical decisions, where the user can independently review 

the basis of the recommendation.

www.fda.gov
9 

Current Regulatory Paradigm Unique Aspects of Digital Health

Rapidly Evolving Situation

9 

Premarket timeline suited for hardware 

based products

software development timelines + software 

development practices + rapid iterations

Deterministic risks, known responsibilities, 

physical products

Emerging issues – (cybersecurity; distributed 

responsibilities, non-physical products)

Potential for exponential increase in volume 

of submissions

Current program volume – 3,500 510(k) 

submissions / 2200 pre-submissions 
10

An Opportunity to Foster Digital Health Innovation 

and Further Public Health

Considering current FD&C 

act authorities and 

implementing regulations
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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 

Explore new streamlined 

pathway for software

Refine policies & 

provide guidance

An Integrated Approach

Issue guidance conforming to software 

provisions of the 21st Century Cures 

legislation

Launch an innovative pilot 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

Build Digital Health unit with right technical 

expertise

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

paradigm
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Digital Health Innovation Action Plan

www.fda.gov

Withdraw 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 SaMD. 

Publish draft guidance: FDA review of 

products with some software functions 

that are devices and some functions that 

are not.

2017 

2018 
13

An agile and learning regulatory paradigm that is:

An opportunity to work together with customers to 

build and prepare for a digital health future

Envisioning a New DH Paradigm

www.fda.gov

Aligned with 

software 

development 

timelines

Aligned with 

industry 

practices and 

real world 

experience

Aligned with 

global 

regulators
www.fda.gov 14

Concept

FDA Pre-Cert for Software

A company based streamlined regulatory approach for 

Software as a Medical Device that relies on a demonstrated 

Culture of Quality and Organizational Excellence 
15

Concept: A Reimagined Approach Using FDA Pre-Cert

www.fda.gov

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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FDA Pre-Cert for SaMD

A voluntary program that allows manufacturers of Software as a Medical Device (“SaMD”) 

to demonstrate their embedded Culture of Quality and Organizational Excellence (CQOE) to 

ultimately participate in a streamlined and predictable FDA regulatory pathway. 

Purpose/Goal

Allows manufacturers of SaMD with FDA Pre-Cert 

status (demonstrated culture of quality and 

organization excellence):

• To have the ability to get SaMD to market faster; 

• To iterate based on real world experience;

• To have an excellent regulatory experience; and 

• To have regulatory predictability. 

Public health/innovation outcomes

1. Companies strive for excellence rather than 

compliance;

2. Promotes high quality and effective innovation; 

3. Transparent FDA Pre-Cert status increases user 

confidence beyond regulatory oversight; and 

4. Allows FDA to focus resources on higher risk 

digital health products.

Providing safe patient experience Being clinically responsible

Being cybersecurity responsible

Being proactive v/s reactive

Delivering highest product quality

Example of CQOE scorecard elements of interest where a company shows 

commitment towards ...

www.fda.gov
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A possible framework to measure 

excellence

www.fda.gov

Organizational 

resource

KPI that demonstrates 

outcome measures in 

leadership, employee 

training, organizational 

support, infrastructure, 

employee 

empowerment, etc.

Customer

KPI that demonstrates 

outcome measures in 

revenue, marketing, 

support, etc.

Learning 

and growth

KPI that demonstrates 

outcome measures in 

product support, 

innovation, employee 

training, stakeholder 

engagement, etc.

Internal 

process

KPI that demonstrates 

outcome measures in 

product engineering, 

management support, 

risk management 

commitment, efficiency, 

revenue, etc. 

Aggregate KPI

PERSPECTIVES

brainstorm

Providing safe patient experience Being clinically responsible

Being cybersecurity responsible

Being proactive v/s reactive

Delivering highest product quality
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FDA Pre-Cert Goals

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. Is a program that learns and adapts (i.e., adjusts/tweaks/evolves scorecard 

elements and key dimensions and measures) based on the effectiveness of the 

program.

www.fda.gov
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A Learning Regulatory Paradigm

www.fda.gov

Evidence 

Commons

DH

Bakul
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Empowering Developers and 

Software Makers

• The RDK would function and have 

components similar to a Software 

Development Kits (“SDK”) that enables 

SaMD manufacturers to efficiently and 

successfully develop high quality safe and 

effective products; and 

 

• The RDK would aid in access to relevant 

regulatory resources and considerations 

that focus on protecting patient safety and 

complying with regulatory expectations.

A toolkit for digital health entrants 

that is usable in an interactive 

manner (not a paper-only guidance 

document or checklist);

Comprehensively includes 

regulatory intent, expectations and 

principles across the SaMD lifecycle; 

Relies on and references existing 

resources and documents (e.g., FDA 

guidance, standards, etc.); and

Amplifies regulatory objectives of 

patient safety and the intent of the 

regulatory requirements.

www.fda.gov
21

Regulatory 

Development 

Kit

Key Building Blocks

www.fda.gov
www.fda.gov 22

Software Precertification 

Pilot Program
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Scope of the Pilot

• Manufacturers developing or 

planning to develop software as a 

medical device (SaMD) as defined by 

IMDRF.

• Limited to maximum of 9 pilot 

participants. 

• Software function not excluded from 

medical device definition by 21st

Century Cures Act.

www.fda.gov

Software is a SaMD when ...

• Software’s output on its own has a medical 

purpose as defined by FD&C act; 

• Can run on any computing platform 

regardless of the location of the platform 

such as generic PC on a network, mobile 

phone, generic computer located within a 

hardware medical device, cloud 

infrastructure.

• Can receive/use input from any general 

purpose peripheral of a computer or a 

sensor that is not specifically intended for a 

medical purpose; 

• Can receive/use data generated by other 

medical devices or in-vitro devices as input; 

• Does not control, or alter functions or other 

parameters of another medical device.

IMDRF SaMD Definition 

Software intended to be used for one or 

more medical purposes that perform 

these purposes without being part of a 

hardware medical device
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From Concept to A Program: An Iterative Approach

www.fda.gov

In 

COLLABORATION 

with Pilot 

Participants + 

Stakeholders 

Concept and 

framework

A streamlined 

Regulatory Program 

for Software
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Key Pilot Program Goals

Program component Deliverable/outcomes of Pilot

Pre-certification 

components

Leverage industry measures to benchmark CQOE elements

Develop and evaluate measure criteria

Develop levels of certification correlated to SaMD risk type

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

Develop and test to mechanics to obtain and maintain certification

Pathway decision criteria

Develop criteria using IMDRF SaMD risk framework and levels of 

certification

Develop and test mechanism/tools for pathway determination

Independent assessment 

flow

Develop optimal submission method and content

Explore options for decreasing / aligning to Pre-Cert status

Post market evidence 

collection

Identify use scenarios and collection scope and methods

Feedback Identify appropriate metrics and KPIs to measure effectiveness of 

the program

www.fda.gov
26

• Applications open 

August 1, 2017 and 

will remain open 

throughout the 

duration of the 

program.

• Companies submit 

statement of interest 

including agreement 

to selection qualities.

• Phased approach 

expected to run from 

September 2017 

through September 

2018.

• 1st phase targeting 

participation with 3 

companies.

www.fda.gov

Pilot Participation

• Company must be in the process of developing or planning 

to develop a software product that meets the definition of a 

device in 201(h) of the FD&C Act.

• Company has an existing track record in developing, testing 

and maintaining software products demonstrating a culture 

of quality and organizational excellence (CQOE) measured 

and tracked by Key Performance Indicators (KPIs) or other 

similar measures.

• While participating in the pilot, the company must agree to: 

– Provide access to CQOE measures, KPIs or similar measures.

– Collect real-world postmarket performance data and provide it 

to FDA.

– Be available for real-time consultations with FDA.

– Be available for site visits from FDA officials.

– Provide information about the firm’s quality management 

system.

Statement of Interest Selection Qualities
27

Expected Pilot Participants Spectrum

Organization size 

Industry

Best in class

SaMD risk profile

Large  small

Traditional (medical device + IVD)

 New entrant to MedTech

Shown by known track record / 

market success in software 

Low  high









www.fda.gov
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Pilot Roles and Responsibilities

www.fda.gov

Participant will also ...

• Collect real-world postmarket performance data 

and provide it to FDA.

• Be available for real-time consultations with FDA.

• Be available for site visits from FDA officials.

• Provide information about the firm’s quality 

management system. 

• Actively help develop criteria 

for precertification and process

• Dedicate resources to partner 

with FDA staff

• Provide access to KPIs or similar 

measures

• Engage in sharing their 

experiences with the Pre-Cert 

pilot to improve the program

• Work collaboratively with the 

participating company

• Work alongside with 

entrepreneurs in residence 

candidates

• Available to answer questions or 

concerns that may arise

• Maintain confidentiality of 

commercial and proprietary 

information

CDRH Staff role Pilot participants role
1 

Pilot Overview

Collect statements 

of interest

Select no more than 

9 participants

Develop program 

elements

www.fda.gov

• Applications accepted 

beginning August 1, 

2017 

• Program will begin 

September 1, 2017

• Enrollment ongoing 

throughout the duration 

of the program

• Best meet selection 

criteria

• Reflect broad spectrum 

of software developers

• Include companies that 

develop a range of both 

low and high risk 

software devices

• Conduct Site visits

• Refine precertification 

elements in 

collaboration with 

participants

• Share findings and 

solicit public input

Interested parties should email their statement of interest 

with subject line “Pre-Cert Pilot: statement of interest” 

to FDAPre-CertPilot@fda.hhs.gov 
30

Key Points

• Pilot is an important first step to help us explore elements of the 

program

• Program is part of the FDA’s ongoing efforts to develop 

pragmatic approaches to balance benefits and risks of digital 

health products

• Collaborate and learn from companies and stakeholders who 

perform high-quality software design, testing and maintenance

• Pilot participants will engage with the FDA to explore:

– Elements of a precertification program that may replace the need for 

premarket submission in some cases; and

– May allow for decreased submission content and/or faster review of 

marketing applications in other cases.

www.fda.gov
31

Questions?

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

Team: digitalhealth@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

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