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Breakthrough Devices Program

Maureen Dreher

Policy Analyst

Clinical Trials Program

Office of Device Evaluation 

Center for Devices and Radiological Health

January 17, 2019
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• Background

• Scope and structure of final guidance

• Differences between draft and final version

• Regulatory framework

• Highlights of final guidance 

• Questions

Agenda
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Objectives

• Understand the following elements:

– Purpose and scope of the Breakthrough Devices Program

– Breakthrough device criteria and what obtaining a 

breakthrough device designation means for a sponsor and 

the FDA review teams

– Administrative process for submitting a breakthrough device 

designation request and how to engage with the FDA after a 

designation has been obtained
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• Q-Submission: submission mechanism to request different types 

of interaction with the FDA

– Requests feedback regarding potential or planned medical 

device submissions

– Request certain formal determinations that are not standalone 

marketing submissions or research authorizations

– Examples include: Pre-Submissions, Study Risk Determinations

• Investigational Device Exemption (IDE): mechanism to request 

approval for a significant risk clinical study of an unapproved device 

or unapproved use of a device

• FD&C Act: Federal Food, Drug & Cosmetic Act

Definitions & Abbreviations
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Context for Breakthrough Devices 

Program Guidance

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 

• Early Feasibility Studies 

• Patient Engagement 

• Real World Evidence

• Breakthrough Devices 

Program

• Case for Quality
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Context for Breakthrough Devices 

Program Guidance

Predecessor programs: Innovation Pathway and Expedited Access 

Pathway

21st Century Cures gives FDA authority to establish program to 

expedite development and review of certain devices 

representing breakthrough technologies – Breakthrough 

Devices Program {now in Section 515B of the FD&C Act}

Guidance issued to clarify policies and procedures for 

implementing the Breakthrough Devices Program

2011 - 2015

Dec 13, 

2016

Dec 18, 

2018
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• Help patients have more timely access to devices

• Expedite device development and review for certain 

medical devices

• Work with sponsors to define a roadmap from early 

stages of device development to FDA marketing 

authorization

– Breakdown perceived barriers

– Collaboration & interaction

Breakthrough Program Purpose
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The Breakthrough Devices Program is a voluntary program for 

certain medical devices and device-led combination products 

that provide for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating diseases or conditions. 

This program is intended to help patients have more timely access to 

these medical devices by expediting their development, 

assessment, and review, while preserving the statutory 

standards for premarket approval, 510(k) clearance, and De Novo 

marketing authorization, consistent with the Agency’s mission to 

protect and promote public health.

Program Definition
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Program Overview

Breakthrough Device 

Designation Request

If granted, may use 

new or traditional 

mechanisms for 

obtaining the FDA’s 

feedback

Marketing Submission

• For granted breakthrough devices, 

• Designation tracks with the device for subsequent submissions

• Prioritized review and other benefits

• If denied, traditional pathways still available for obtaining 

the FDA’s feedback (for example, Pre-Submissions) and 

marketing submission
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• Summarizes the policies under which the FDA’s Breakthrough 

Devices Program operates 

• Clarifies the administrative processes used to facilitate review of 

breakthrough devices designation requests 

• Provides an overview of options for obtaining the FDA’s 

feedback to support device development

Scope of Guidance
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• Revised structure of guidance to be consistent with the chronology 

of how sponsors enter the program and use its features

• Clarified medical products that may be eligible for the program

• Clarified policies and procedures for obtaining the FDA’s feedback 

following breakthrough designation

Differences Between 

Draft and Final Guidance
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• Introduction and background for Breakthrough Devices Program

• Program principles

• Components of a designation request, including a description of the 

statutory criteria

• Subsequent regulatory mechanisms for obtaining feedback on 

granted breakthrough devices

Structure of Guidance
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Eligibility for Breakthrough Devices Program
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• Medical devices and device-led combination products are eligible

• Subject to marketing authorization via Premarket Approval (PMA), 

De Novo, or 510(k)

• Meets the breakthrough criteria specified in Section 515B(b) of the 

Federal Food, Drug & Cosmetic Act

Eligibility Considerations
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Breakthrough Device Criteria

• Criterion 1: “provide for more effective treatment or diagnosis of 

life-threatening or irreversibly debilitating human disease or 

conditions; AND

Reference: Section 515B(b)(1) of Food, Drug and Cosmetic Act
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Breakthrough Device Criteria

Meets one of the following sub-parts in Criterion 2: 

• 2A: that represent breakthrough technologies; or

• 2B: for which no approved or cleared alternatives exist; or

• 2C: that offer significant advantages over existing approved or 

cleared alternatives, including the potential, compared to existing 

approved alternatives, to reduce or eliminate the need for 

hospitalization, improve patient quality of life, facilitate patients’ 

ability to manage their own care (such as through self-directed 

personal assistance), or establish long-term clinical efficiencies; or

• 2D: the availability of which is in the best interest of patients.”

Reference: Section 515B (b)(2) of Food, Drug and Cosmetic Act
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A Closer Look at Criterion 1

• Criterion 1: Provides for more effective treatment or 

diagnosis of life threatening or irreversibly debilitating 

disease or condition

– Is the condition life-threatening or irreversibly debilitating?

– Consider if there is reasonable expectation that the device could 

provide for more effective treatment or diagnosis relative to current 

standard of care in the U.S.

– Consider non-clinical data (bench, animal study), literature, scientific 

rationale

– Clinical data not required but can be helpful
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A Closer Look at Criterion 2

• Criterion 2A: represents a breakthrough technology

– Consider technological advances or new use of an existing 

technology

– Consider potential to lead to clinical improvement

• Criterion 2B: no approved or cleared alternatives 

exist

– Consider whether there is an approved drug, biologic, or 

device for the same indication that is consistent with standard 

of care
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A Closer Look at Criterion 2

• Criterion 2C: significant advantages over existing approved/ 

cleared alternatives

– Consider whether the device may “reduce or eliminate the need for 

hospitalization, improve patient quality of life, facilitate patients’ ability to 

manage their own care (such as through self-directed personal 

assistance) or establish long-term clinical efficiencies”

• Criterion 2D: Availability of device is in the best interest of 

patients

– Consider other types of specific public health benefits

– For example, potential for the device to address a known failure mode or 

has a benefit for patients who are unable to tolerate available therapies

FD&C Act Section 515B(e)
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Policies and Procedures for Breakthrough 

Devices Program
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• Derived from provisions in Section 515B Food, Drug & Cosmetic 

Act

– Interactive and timely communication

• Review team support

• Senior management involvement

• Engaging external experts during review

– Prioritized review of subsequent submissions (for example, QSubmissions, Investigational Device Exemptions (IDE), 

marketing submission)

Program Principles

Section 515B(e), FD&C Act
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• Opportunities for the following as scientifically appropriate 

– Premarket and postmarket balance of data collection

– Application of flexible and efficient clinical study design

– Expedited manufacturing and quality systems compliance review 

for breakthrough devices subject to premarket approval 

application 

Program Principles
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• Submitted as a “Designation Request for Breakthrough Device” QSubmission

– A standalone submission distinct from other requests for feedback

– Includes the following elements (Appendix 1):

• Device description including principles of operation, properties 

relevant to clinical function, images or engineering schematics

• Proposed Indication for Use

• Justification for how the device meets the designation criteria

• Planned marketing application

• More information available in Appendix 1 of the guidance

What to Include in a Designation 

Request
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Designation Request Timeframe

Request Received –

FDA Day 0

Statutory 

deadline for 

final decision –

Day 60

FDA sends formal 

deficiency letter, if 

needed – Day 30

Sponsor responds to 

deficiencies, if applicable 

– Day 45

Breakthrough Device 

Designation Request Process
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• Various options available for feedback on device 

development after a breakthrough device designation has 

been granted

– “Interaction for Designated Breakthrough Device” QSub:

• Data Development Plan 

• Breakthrough device “sprint” discussion

• Clinical protocol agreement

• Pre-Submissions

• Regular status updates

Program Features
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• High-level optional document intended to help ensure predictable and 

transparent review by outlining data collection expectations for the 

entire product lifecycle

– Addresses non-clinical and clinical evaluations

– Describes any proposed use of balancing premarket and postmarket 

data collection

• Often the first submission following a granted breakthrough designation

• Review timeframe

– Target of 45-day review period for providing formal feedback

– Face-to-face meeting or teleconference can be held

Data Development Plan (DDP)
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DDP Example Formats

Non-clinical Test Reference Standard, Method, Acceptance 

Criteria, Objective, etc. Timeline

Test name/type.

Examples: Electromagnetic 

compatibility, 

biocompatibility, animal 

study

Relevant standard, description of method, 

acceptance criteria, objective, etc. to describe 

testing expectations.

Examples: IEC 60601-1-2; sensitization and 

irritation testing per ISO 10993; acute animal 

study to assess functionality

When test results should be 

provided to FDA.

Examples: In feasibility study 

IDE, in pivotal study IDE, in 

marketing application, in 

post-approval study.

Clinical Study (include type of clinical study; for example, feasibility study/pivotal study)

Purpose of Study

Study Design

Study Population including:

• Population description

• Inclusion criteria

• Exclusion criteria

Safety & Effectiveness Endpoints

• List each separately and include any 

references to clinically recognized scales, 

statistical analyses as needed

Follow-up Schedule

• Include relevant 

timepoints and 

assessments

More information available in Appendix 2 of the guidance
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• For sponsors needing timely resolution of issues for device 

development progress

• Highly interactive with ability for sponsor to provide additional 

information and proposals during the review

– Please be ready to engage and respond to the FDA’s feedback

• Goal of reaching mutual agreement

• Single topic with refined goals

– For example, animal study protocol

• Example timeline provided in guidance

– Intended to occur over a relatively short timeframe

• Sprint discussion ends with summary of final feedback and extent of 

agreement sent to sponsor

Sprint Discussion
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• Mechanism for obtaining written agreement on a clinical protocol 

• Considered binding on both the FDA and sponsor

• Documented agreement in a letter

Clinical Protocol Agreement

Reference: Section 515B(e)(2)(D) of the FD&C Act
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• Breakthrough device sponsors may use other regulatory 

mechanisms for feedback

– More traditional Pre-Submission topics that are tracked as an 

Interaction for Designated Breakthrough Device QSubmission to facilitate prioritized review

– Other types of Q-Submissions (for example, Study Risk 

Determinations, Submission Issue Meetings)

• Priority review for Investigational Device Exemptions (IDE) and 

marketing submissions

Subsequent Regulatory 

Submissions
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• Brief email or teleconference updates between sponsor and lead 

reviewer on progress of device development

• In between formal submissions

• No data or feedback in the discussions

• Suggested intervals of every other month, or as agreed to by both 

parties

Status Updates
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• Breakthrough Devices Program is a voluntary program intended to 

expedite development and review of certain medical devices to treat or 

diagnose life-threatening or irreversibly debilitating diseases or 

conditions

• A formal designation process where sponsors provide evidence and/or 

justification for how their device meets the statutory criteria

• Provides sponsor with various mechanisms to engage FDA early to 

expedite development and review of device

• Program success depends on commitment and engagement of both 

FDA and sponsors

Conclusion
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• Breakthrough Devices Program webpage: 

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour

Device/ucm441467.htm

• Breakthrough Devices Program Final Guidance: 

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidan

ceDocuments/UCM581664.pdf

Resources
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Questions?

For questions regarding the Breakthrough Devices Program (for 

example, appropriate use and review process), please contact: 

BreakthroughDevicesProgram@fda.hhs.gov

For general questions, 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: “How to Study and Market Your Device” and 

subheading: “IDE”