Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while additional time is 

provided for participants to join the call. 

If you have not connected to the audio portion of the 

webinar, please do so now:

U.S. Dial: 1-888-455-1392

International Dial: 1-773-799-3847 

Conference number: PWXW1929130

Audience passcode: 5640600
Safer Technologies Program (STeP) for 

Medical Devices Final Guidance

Devjani Saha

Policy Analyst

Division of Clinical Science and Quality

Office of Clinical Evidence & Analysis

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

February 1, 2021
3

Objectives

Understand the following:

• Purpose and scope of the new, voluntary Safer Technologies 

Program (STeP) 

• Eligibility factors for inclusion in STeP

• Programmatic principles and features of STeP
4

• Background

• Overview of the guidance

• Highlights of STeP

– Program Principles

– Eligibility Factors

– Mechanisms for Feedback

• Summary, Resources, and Questions

Agenda
5

• Background

• Overview of the guidance

• Highlights of STeP

– Program Principles

– Eligibility Factors

– Mechanisms for Feedback

• Summary, Resources, and Questions

Agenda
6

• A new, voluntary program for certain types of medical devices and device-led 

combination products that are reasonably expected to significantly improve the 

safety of currently available medical treatments and diagnostics through 

innovative technological features

• Focused on increasing timeliness of patient access to these medical devices

• Preserves the statutory standards for marketing authorization

• STeP is modeled on some principles and features of the Breakthrough Devices 

Program, but is for devices that target underlying diseases or conditions 

associated with morbidities less serious than those eligible for breakthrough 

designation

Safer Technologies Program 
7

STeP Timeline

Medical Device Safety 

Action Plan

April 12, 2018

Anticipated 

program 

implementation 

March 8, 2021

Guidance drafted

Draft published 

September 19, 2019

Final guidance issued 

January 6, 2021

STeP

Guidance 

Webinar

Public comments 

received, incorporated 

into final guidance

GO 
8

• Outlines vision for how the FDA can 

continue to enhance programs and 

processes to assure the safety of 

medical devices

• Safer Technologies Program (STeP) 

motivated by the FDA’s Medical 

Device Safety Action Plan1

Medical Device Safety Action Plan

1 Medical Device Safety Action Plan https://www.fda.gov/media/112497/download
9

One goal discussed in the plan is to spur innovation towards 

safer medical devices. The FDA intends to: 

• Advance policies that encourage innovation and facilitate 

timely patient access to safe and effective medical devices 

• Explore actions and regulatory incentives to encourage the 

development of technologies that make devices and their 

use safer 

- Leverage policies and program features similar to those 

available under the FDA's Breakthrough Devices Program

Medical Device Safety Action Plan
10

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

Breakthrough Device Program guidance: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/breakthrough-devices-program

• Voluntary program for medical devices and device-led combination 

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

• Unlike STeP, the Breakthrough Devices Program is statutorily mandated

• Key Program Principles:

– Expedite device development and review

– Opportunities for interaction to efficiently support device development 

– Increased opportunity for senior management involvement

Breakthrough Devices Program
11

• Breakthrough Devices Program is for devices that treat or diagnose 

life-threatening or irreversibly debilitating diseases or conditions

• Devices that treat or diagnose less serious conditions than those 

eligible for Breakthrough Devices Program can still result in 

complications and/or serious adverse events

Motivation for STeP
12

• Breakthrough Devices Program is for devices that treat or diagnose 

life-threatening or irreversibly debilitating diseases or conditions

• Devices that treat or diagnose less serious conditions than those 

eligible for Breakthrough Devices Program can still result in 

complications and/or serious adverse events

• Efforts to improve safety are directly related to improving overall 

clinical benefits  Public health benefit

• The FDA recognizes the need to expedite development and review of 

devices that may make significant safety improvements  STeP

Motivation for STeP
13

• Background

• Overview of the guidance

• Highlights of STeP

– Program Principles

– Eligibility Factors

– Mechanisms for Feedback

• Summary, resources, and questions

Agenda
14

Document includes:

• Introduction and Background

• Program Principles

• Eligibility Factors for STeP Entrance and Review Process

• Mechanisms for Feedback on Devices Included in STeP

Overview of the Guidance
15

• Final guidance issued on January 6, 2021

• The FDA revised the final guidance in response to stakeholder comments:

– Further explanation of program scope

– Clarification of the review timelines

– Emphasized that participation in STeP does not impact the statutory 

requirements for marketing authorization nor does it affect the 

application of least burdensome policies and approaches. 

Changes from Draft to Final Guidance
16

• Background

• Overview of the guidance

• Highlights of STeP

– Program Principles

– Eligibility Factors

– Mechanisms for Feedback

• Summary, resources, and questions

Agenda
17

STeP Overview

STeP Entrance 

Request

If included, may use 

traditional or 

program-specific 

mechanisms for 

obtaining FDA 

feedback

Marketing 

Submission

• If included in STeP, subsequent submissions receive programmatic benefits

• If denied inclusion in STeP, traditional pathways still available for obtaining 

FDA feedback (e.g., pre-Submissions) and marketing pathways remain 

unchanged 
18

STeP Program Principles

To expedite development and review of devices included in STeP, the FDA 

intends to apply the following principles, when appropriate and as 

resources permit:

• Interactive and timely communication

• Review team support and senior management engagement

• Timely postmarket data collection

• Efficient and flexible clinical study design

• Expedited review of manufacturing and quality systems compliance for 

devices with preapproval inspection requirements
19

STeP Program Principles

Sponsors of devices under this program are expected to work interactively 

with the FDA, and, in a timely manner to:

• Respond to FDA requests 

• Collect premarket and postmarket data 

• Market their devices, if authorized
20

• Inclusion in STeP is only at the request of the sponsor and with the FDA’s 

agreement 

– Sponsors should submit STeP entrance requests as a Q-submission

– The FDA intends to include device in STeP or deny inclusion within 60 

calendar days of receipt

• Device should meet both the general and specific program eligibility factors

STeP Program Eligibility
21

General Eligibility Factor:

Device should be subject to marketing authorization via the PMA, De Novo 

request, or 510(k) pathways

• For device-led combination products subject to these marketing pathways, 

the FDA intends to evaluate which constituent part of the product (i.e., 

device or drug/biologic) is providing the proposed safety improvement, and 

to only consider including products in STeP if the safety improvements are 

made to the device constituent part

General STeP Program Eligibility Factor
22

In addition to the general eligibility factor, device should also meet specific eligibility 

factors.

Specific Eligibility Factors:

1. Device should not be eligible for the Breakthrough Devices Program due to the less 

serious nature of the disease or condition treated, diagnosed, or prevented by the 

device; 

and

2. Device should be reasonably expected to significantly improve the benefit-risk profile of 

a treatment or diagnostic through substantial safety innovations that provide for one or 

more of the following:

a) a reduction in the occurrence of a known serious adverse event,

b) a reduction in the occurrence of a known device failure mode,

c) a reduction in the occurrence of a known use-related hazard or use error, or

d) an improvement in the safety of another device or intervention.

STeP Program Eligibility Factors
23

In addition to the general eligibility factor, the device should also meet specific eligibility 

factors.

Specific Eligibility Factors:

1. Device should not be eligible for the Breakthrough Devices Program due to the less 

serious nature of the disease or condition treated, diagnosed, or prevented by the 

device; 

and

2. Device should be reasonably expected to significantly improve the benefit-risk profile of 

a treatment or diagnostic through substantial safety innovations that provide for one or 

more of the following:

a) a reduction in the occurrence of a known serious adverse event,

b) a reduction in the occurrence of a known device failure mode,

c) a reduction in the occurrence of a known use-related hazard or use error, or

d) an improvement in the safety of another device or intervention.

STeP Program Eligibility Factors
24

Specific Eligibility Factor 1:

Device should not be eligible for the Breakthrough Devices Program due to the less 

serious nature of the disease or condition treated, diagnosed, or prevented by the device;

Such diseases or conditions may:

• Be considered non-life-threatening or reasonably reversible

• Affect patient quality of life or be debilitating for short timeframes

• Be associated with health consequences that do not significantly impact daily 

function, and/or might not progress to a more serious disease or condition

Specific Eligibility Factor 1
25

In addition to the general eligibility factor, the device should also meet specific eligibility 

factors.

Specific Eligibility Factors:

1. Device should not be eligible for the Breakthrough Devices Program due to the less 

serious nature of the disease or condition treated, diagnosed, or prevented by the 

device; 

and

2. Device should be reasonably expected to significantly improve the benefit-risk profile of 

a treatment or diagnostic through substantial safety innovations that provide for one or 

more of the following:

a) a reduction in the occurrence of a known serious adverse event,

b) a reduction in the occurrence of a known device failure mode,

c) a reduction in the occurrence of a known use-related hazard or use error, or

d) an improvement in the safety of another device or intervention.

STeP Program Eligibility Factors
26

Specific Eligibility Factor 2:

Device should be reasonably expected to significantly improve the benefit-risk profile of a 

treatment or diagnostic through substantial safety innovations...

Some considerations:

• The device should be reasonably expected to make a clinically meaningful improvement 

in the prevalence and/or severity of the safety issue

• Safety improvements should not compromise the device’s effectiveness

• FDA intends to consider whether the safety innovation introduces the potential for new 

serious adverse events or use-related hazards and their impact to the benefit-risk profile

• A substantial safety innovation is one that incorporates an innovative technological 

feature or represents an innovative use of a technology to accomplish the significant 

safety improvement

Specific Eligibility Factor 2
27

In addition to the general eligibility factor, the device should also meet specific eligibility 

factors.

Specific Eligibility Factors:

1. Device should not be eligible for the Breakthrough Devices Program due to the less 

serious nature of the disease or condition treated, diagnosed, or prevented by the 

device; 

and

2. Device should be reasonably expected to significantly improve the benefit-risk profile of 

a treatment or diagnostic through substantial safety innovations that provide for one or 

more of the following:

a) a reduction in the occurrence of a known serious adverse event,

b) a reduction in the occurrence of a known device failure mode,

c) a reduction in the occurrence of a known use-related hazard or use error, or

d) an improvement in the safety of another device or intervention.

STeP Program Eligibility Factors
28

Specific Eligibility Factor 2a:

Device should be reasonably expected to significantly improve the benefit-risk profile of a 

treatment or diagnostic through substantial safety innovations that provide for...

(a) a reduction in the occurrence of a known serious adverse event

Some considerations:

• The device should be reasonably expected to result in a significant reduction in the 

occurrence of a known serious adverse event, based on device principles of 

operation

• The FDA intends to consider serious adverse events that are reasonably attributed 

to use of a medical product that occur in acute timeframes as well as those that are 

associated with long term adverse outcomes

Specific Eligibility Factor Considerations
29

Specific Eligibility Factor 2b:

Device should be reasonably expected to significantly improve the benefit-risk profile of a 

treatment or diagnostic through substantial safety innovations that provide for...

(b) a reduction in the occurrence of a known device failure mode

Some considerations:

• Device should be reasonably expected to reduce the occurrence of a known failure 

mode that is likely to result in serious adverse health consequences, including those 

that are likely to result in death, to be life-threatening, or to involve permanent or 

long-term injuries to patients

• Device should not be addressing hypothetical device failure modes

Specific Eligibility Factor Considerations
30

Specific Eligibility Factor 2c:

Device should be reasonably expected to significantly improve the benefit-risk profile of a 

treatment or diagnostic through substantial safety innovations that provide for...

(c) a reduction in the occurrence of a known use-related hazard or use error

Some considerations:

• Use-related hazard or use error may result in serious safety issues for patient as 

well as device user (e.g., clinician, caretaker)

• The device should address errors or hazards associated with device design or 

operational features rather than those stemming from inadequate or unclear labeling

Specific Eligibility Factor Considerations
31

Specific Eligibility Factor 2d:

Device should be reasonably expected to significantly improve the benefit-risk profile of a 

treatment or diagnostic through substantial safety innovations that provide for...

(d) an improvement in the safety of another device or intervention

Some considerations:

• The device is expected to offer a specific and significant type of improved safety 

benefit for another medical device or intervention

• Device requesting inclusion in STeP should be the finished device but may or may 

not be a medical device accessory*

*https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories

Specific Eligibility Factor Considerations
32

• Requests for inclusion in STeP are submitted as “STeP Entrance Request” Q-submissions

– Submission should not include other requests for feedback (e.g, Data Development Plan)

• Appendix 1 includes an illustrative example of the type of information that should be included 

in the request:

– Device description, including principles of operation, properties relevant to clinical 

function, images or engineering schematics

– Expected safety improvement

– Proposed Indications for Use

– Regulatory history (if applicable)

– Justification for how the device meets the general eligibility factors

• Planned marketing application

– Justification for how the device meets the specific eligibility factors

STeP Entrance Requests
33

• The FDA’s review of STeP entrance requests will include assessment of how the device 

meets general and specific program eligibility factors

• Review timeline

– The FDA intends to request additional information, if needed, by 30 days after receipt

• These requests do not stop the review clock

– Sponsor response to additional information expected by the date stipulated in the 

additional information request

– The FDA intends to notify sponsor whether or not the device has been included by 

day 60

• STeP has a delayed implementation in order to operationalize the program

– The FDA currently anticipates accepting STeP Entrance Requests for review 

beginning on March 8, 2021

STeP Entrance Requests
34

Regulatory Path

• A device’s inclusion or denied inclusion in STeP does not constitute a formal 

decision regarding the applicable regulatory pathway or device classification.

• Inclusion of a device into STeP does not constitute a decision on whether the 

device is an accessory or on its risk classification.

Timeframe for STeP Entrance Request

• Requests for inclusion in STeP should be submitted prior to marketing submission, 

but the FDA may consider requests submitted in parallel

Multiple Devices for Same Expected Safety Benefit

• The FDA may include multiple devices in STeP that are intending to address the 

same safety issue or improvement

Additional Considerations for STeP

Entrance Requests
35

FDA intends to offer sponsors of devices included in STeP the following 

options for early and regular interaction with the FDA, as resources permit:

1. Sprint discussion: Discussions with the goal of reaching mutual 

agreement on a specific topic within a set time period (e.g., 45 days) 

2. Review of a Data Development Plan (DDP): A DDP is an optional, 

high-level document outlining (non-clinical and/or clinical) data collection 

expectations, including timing, for the entire product lifecycle

3. Pre-submission: Covers a broader scope of topics in a singlesubmission

4. Regular Status Updates: routine informational only updates

Mechanisms for Feedback on Development 

of Devices in STeP
36

• Use of these feedback options is not mandatory

• Sponsors submit requests for STeP sprint discussions, DDP reviews, and Presubmission feedback as Q-Submissions

– Cover letter should identify the Q-submission as a “STeP Interaction 

Request”

• Regular status updates are informal interactions without separate submissions

• As resources permit, the FDA intends to provide feedback on STeP interaction 

submissions in less time than would be expected for a traditional presubmission

Mechanisms for Feedback on Development 

of Devices in STeP
37

• Background

• Overview of the guidance

• Highlights of STeP

– Program Principles

– Eligibility Factors

– Mechanisms for Feedback

• Summary, resources, and questions

Agenda
38

• As part of Medical Device Safety Action Plan, FDA is introducing a 

new, voluntary program to spur innovation towards safer medical 

devices through an approach similar to the Breakthrough Devices 

Program.

• The Safer Technologies Program (STeP) intends to apply similar 

principles and programmatic features to devices with safety 

innovations that target less serious diseases or conditions than 

Breakthrough Devices Program.

• We are currently operationalizing the program and at this time 

anticipate accepting entrance requests beginning on March 8, 2021. 

Summary
39

• Final guidance document available here:

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/safer-technologies-program-medicaldevices

• Safer Technologies Program webpage: 

https://www.fda.gov/medical-devices/how-study-and-marketyour-device/safer-technologies-program-step-medical-devices

• Program mailbox: SaferTechnologiesProgram@fda.hhs.gov

Resources
40

Questions?

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 Heading: How to Study and Market Your Device; 

Subsection: Cross-Cutting Premarket Policy

Please complete a short survey about your FDA CDRH 

webinar experience. The survey can be found here

immediately following the conclusion of the live webinar