Contains Nonbinding Recommendations 
 
 
Safer Technologies Program for 
Medical Devices 
 
 
 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on January 6, 2021. 
 
The draft of this document was issued on September 19, 2019. 
 
 
 
For questions about this document regarding CDRH-regulated devices, contact OCEA: Office of 
Clinical Evidence and Analysis/DCEA1: Division of Clinical Science and Quality at 301-796-
5550 or SaferTechnologiesProgram@fda.hhs.gov. For questions about this document regarding 
CBER-regulated devices, contact the Office of Communication, Outreach, and Development 
(OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research  
 
   
 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  
Identify all comments with the docket number FDA-2019-D-4048. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
 
Additional Copies 
 
CDRH 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 19001 and complete title of the guidance in the request. 
 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 
   
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents
 
 
I.  Introduction ............................................................................................................................. 1 
 
II.  Background ............................................................................................................................. 2 
III.  Program Principles .................................................................................................................. 3 
A.  Interactive and Timely Communication ........................................................................... 4 
B.  Review Team Support ...................................................................................................... 4 
C.  Review of Regulatory Submissions ................................................................................. 5 
D.  Benefit-Risk Assessments and Pre/Post-Market Balance of Data Collection .................. 5 
E.  Efficient and Flexible Clinical Study Design ................................................................... 6 
F.      Manufacturing Considerations for PMA Submissions ..................................................... 7 
IV.  Factors for STeP Entrance and Review Process ..................................................................... 7 
A.  General Eligibility Factor ................................................................................................. 7 
B.  Specific Eligibility Factors  .............................................................................................. 8 
C.  Considerations for Evaluating Specific STeP Eligibility Factors .................................... 8 
(1)  First Factor .................................................................................................................... 8 
(2)  Second Factor ............................................................................................................... 8 
D.  Additional Considerations for STeP Entrance Review .................................................. 11 
(1)  Regulatory Path .......................................................................................................... 11 
(2)  Timeframe for STeP Entrance Request ...................................................................... 13 
(3)  Multiple Devices for the Same Expected Safety Benefit ........................................... 13 
E.  Submitting a Request for Inclusion in STeP and FDA Review ..................................... 14 
F.      Withdrawal and Disqualification from STeP After Program Inclusion ......................... 14 
V.  Mechanisms for Feedback on Development of Devices in STeP ......................................... 15 
A.  Sprint Discussion............................................................................................................ 16 
B.  Data Development Plan (DDP) ...................................................................................... 17 
C.  Other Pre-Submissions for STeP Devices ...................................................................... 17 
D.  Regular Status Updates .................................................................................................. 18 
Appendix 1: Illustrative Example: Recommended Contents of a Q-Submission Request for 
Inclusion in STeP .......................................................................................................................... 19 
 
  Contains Nonbinding Recommendations 
 
 
 
Safer Technologies Program for 
Medical Devices 
 
 
Guidance for Industry and 
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
I.  Introduction1 
The FDA is introducing a new, voluntary program for certain medical devices and device-led 
combination products2 that are reasonably expected to significantly improve the safety of 
currently available treatments or diagnostics that target an underlying disease or condition 
associated with morbidities and mortalities less serious than those eligible for the Breakthrough 
Devices Program; for example, this may include devices treating or diagnosing non-life-
threatening or reasonably reversible conditions. Devices and device-led combination products 
are eligible for this program if they are subject to review under a premarket approval application 
(PMA), De Novo classification request (De Novo request), or premarket notification (510(k)), 
taking into account the specific eligibility factors described in this document. Consistent with the 
Agencys statutory mission3 to protect and promote public health, FDA believes that this Safer 
Technologies Program or STeP will help patients have more timely access to these medical 
devices and device-led combination products by expediting their development, assessment, and 
review, while preserving the statutory standards for premarket approval, De Novo marketing 
authorization, and 510(k) clearance. FDA has modeled STeP on the principles and features of 
FDAs Breakthrough Devices Program as mandated in section 515B of the Federal Food, Drug 
                                                 
1 The Office of Combination Products (OCP) and the Center for Drug Evaluation and Research (CDER) were 
consulted in the preparation of this guidance. 
2 A combination product is defined in 21 CFR 3.2(e).  For purposes of this guidance, device-led combination 
products refer to combination products subject to review under a premarket approval application (PMA), premarket 
notification (510(k)), or De Novo classification request.   
3 See section 1003(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
 
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and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3) and further described in the FDA guidance 
document entitled Breakthrough Devices Program4 (hereinafter referred to as the 
Breakthrough Devices Program guidance document). As resources permit, FDA intends for 
STeP to incorporate similar features offered under the Breakthrough Devices Program, such as 
interactive and timely communications, early engagement on Data Development Plans (DDPs), 
sprint discussions, and senior management engagement.  
     
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.5 For more information 
regarding use of consensus standards in regulatory submissions, please refer to the FDA 
guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices6 and Standards Development and the Use of Standards in Regulatory 
Submissions Reviewed in the Center for Biologics Evaluation and Research.7    
 
FDA recognizes and anticipates that the Agency may need up to 60 days to perform activities to 
operationalize this Safer Technologies Program following issuance of this guidance. FDA does 
not intend to accept requests for inclusion in STeP within this time period.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
  
II.  Background 
FDA is responsible for protecting and promoting public health by ensuring the safety and 
effectiveness of medical products.8 Additionally, FDA has a role to play in advancing public 
health by helping to provide timely access to innovations that make medical products and their 
use safer and more effective.9 In recent years, FDA has developed policies and implemented new 
programs designed to promote patient access to innovative and safe new therapies and 
diagnostics. An important example of this approach is the Breakthrough Devices Program, which 
superseded the Expedited Access Pathway and Priority Review Program. The Breakthrough 
Devices Program is intended to expedite the development and review of certain devices that meet 
                                                 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.  
5 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices. 
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-and-use-
standards-regulatory-submissions-reviewed-center-biologics-evaluation.  
8 For more information about CDRHs vision for medical device safety, see Medical Device Safety Action Plan: 
Protecting Patients, Promoting Public Health, available at https://www.fda.gov/about-fda/cdrh-reports/medical-
device-safety-action-plan-protecting-patients-promoting-public-health. 
9 See FDAs Mission, available at https://www.fda.gov/about-fda/what-we-do. 
 
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the designation criteria for the program and treat life-threatening or irreversibly debilitating 
diseases or conditions.10   
 
FDA recognizes that, although medical products provide great benefits to patients, they also 
present risks. FDA strives to permit marketing only for products with a favorable benefit-risk 
profile. However, patients may experience a wide range of adverse events attributed to use of the 
medical product including those that are considered serious, resulting in death or serious injury.11  
These types of events may negatively impact patients and their quality of life. Safety and 
innovation are both important priorities for the Agency, and improvements in each of these areas 
are expected to result in increased quality of life and health benefits for patients, while providing 
a reasonable assurance of both safety and effectiveness. 
 
As a complement to the Breakthrough Devices Program, FDA believes that advancements in 
medical devices that are ineligible for the Breakthrough Devices Program but offer a significant 
safety advantage in treating and/or diagnosing less serious diseases or conditions can also 
provide an important public health benefit. Therefore, FDA is developing STeP to help spur 
safety innovation for medical devices and to provide patients timely access to devices that are 
not eligible for the Breakthrough Devices Program and may offer significant improvements to 
the safety profile of available medical treatments.12 FDA believes that efforts to improve safety 
are directly related to improving overall clinical benefits and may also help patients experience 
fewer serious adverse events.  
 
III.  Program Principles 
Similar to the Breakthrough Devices Program, STeP is comprised of two phases. In the first 
phase, interested sponsors formally request inclusion in STeP through a Q-submission (Section 
IV and Appendix 1). The second phase encompasses actions to expedite the development of the 
device and review of subsequent regulatory submissions (e.g., pre-submissions, marketing 
submissions) (Section V).   
 
The principles below describe the philosophy of STeP and the approach FDA intends to take for 
review of devices included in the program. As resources permit, FDA intends to leverage many 
of the principles of the Breakthrough Devices Program for STeP in order to expedite the 
development and review of devices that have the potential to significantly improve safety. As 
part of the program, FDA and the sponsor should work collaboratively to define an efficient 
device development path towards obtaining an FDA marketing authorization consistent with 
                                                 
10 The designation criteria are defined in section 515B of the FD&C Act and described in the Breakthrough Devices 
Program guidance document. 
11 The types of events that must be reported to FDA pursuant to 21 CFR part 803 are described in the FDA guidance 
document entitled Medical Device Reporting for Manufacturers, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/medical-device-reporting-manufacturers. 
12 See Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, available at 
https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-
public-health. 
 
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least burdensome approaches13 and the statutory standards for premarket approval, De Novo 
marketing authorization, and 510(k) clearance. To benefit from the policies outlined for STeP, 
the commitment on behalf of the sponsor to resolve all scientific and regulatory issues in a timely 
manner should match that of FDA. FDA believes that this sponsor commitment, in conjunction 
with effective communication (e.g., interactive review) and collaboration, is necessary to 
expedite the availability of safe and effective medical devices. 
 
FDA intends to evaluate resources throughout the device development, assessment, and review 
processes to make the best use of FDAs resources and maximize the impact of STeP. However, 
when necessary, FDA plans to prioritize resources for the Breakthrough Devices Program over 
STeP because the Breakthrough Devices Program is statutorily mandated. 
A.  Interactive and Timely Communication 
For devices in STeP, FDA intends to provide interactive and timely communication with the 
sponsor during device development and throughout the review process for Q-submissions, 
Investigational Device Exemption (IDE) applications, PMAs, certain PMA supplements (i.e., 
Panel Track Supplements, 180 Day PMA Supplements), 510(k)s, and/or De Novo requests. To 
promote collaborative dialogue and interaction between FDA and the sponsor, both parties 
should, as applicable: 
  
  agree on the goals of the interaction and feasibility of response timeframes prior to 
submission of, or early in the review of, one of the relevant regulatory submissions listed 
above;  
  utilize redlined versions of documents being reviewed and/or revised interactively for 
transparent communication concerning proposed changes; and  
  utilize summary tables, documents, and/or FDA correspondence (e.g., written feedback, 
meeting minutes) to communicate points of agreement, disagreement, or unresolved 
issues at the conclusion of a review period.   
 
Given that there may be novel scientific aspects of devices in STeP, FDA may need to interact 
with external experts or seek advice from an advisory committee to reach various regulatory 
decisions.14 In the event that such consultation is undertaken, FDA intends to follow the 
approach outlined in Section II.A of the Breakthrough Devices Program guidance document.  
B.  Review Team Support 
For regulatory submissions (i.e., Q-submissions, IDEs, and marketing submissions as listed 
above in Section III.A.) for devices included in STeP, FDA intends to provide a high level of 
                                                 
13 For more information, see FDAs guidance, The Least Burdensome Provisions: Concept and Principles - 
Guidance for Industry and Food and Drug Administration Staff, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles. 
14 For more information with respect to CDRH, see FDAs guidance, Procedures for Meetings of the Medical 
Devices Advisory Committee, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/procedures-meetings-medical-devices-advisory-committee. In the event CBER seeks advisory committee 
input on a device included in STeP, CBER intends to hold a Blood Products Advisory Committee (BPAC) or 
Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) meeting. 
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  Contains Nonbinding Recommendations 
 
review team support and increased senior management (e.g., Office director or designee 
representing Office director) engagement, as resources permit. Specifically, senior management 
intend to be involved in regulatory submissions for devices in STeP to ensure adherence to 
programmatic principles and to support efficient and timely dispute resolution when points of 
disagreement cannot be resolved quickly.     
 
FDA intends for review teams of devices in STeP to be trained on programmatic principles and 
features as outlined herein, so that they are prepared to apply novel approaches to regulatory and 
device development challenges. 
C.  Review of Regulatory Submissions  
FDA intends to provide additional review resources for the reviews of regulatory submissions for 
devices in STeP, as available, similar to prioritized review in the Breakthrough Devices Program. 
Devices included in STeP are anticipated to present technological or design innovations that may 
raise novel and/or complex scientific and/or regulatory issues.  FDA believes that STeP may 
enable patients to have more timely access to these devices than they would have had otherwise, 
due to earlier interaction between FDA and sponsors, dedication of additional resources, 
application of program principles (Section III), and use of program features (Section V) during 
the device development process to address scientific or regulatory issues. However, even with 
earlier interactions, FDAs past experience with the Priority Review Program15 indicates that 
innovative products may raise additional scientific and regulatory issues that warrant more in-
depth review during FDAs review of the marketing submission.  Therefore, the timeframe for 
review of the marketing submission may take longer for devices in STeP than for other less 
novel devices.  
 
Given that the purpose of STeP is earlier access to devices that address important known safety 
issues, sponsors of devices under this program are expected to work interactively16 with FDA 
and respond to FDA requests, collect premarket and postmarket data, and market their devices, if 
authorized, in a timely manner. Sponsors of these devices should commit to resolving all 
scientific and regulatory issues during the review process as efficiently as possible.  
D.  Benefit-Risk Assessments and Pre/Post-Market Balance 
of Data Collection  
                                                 
15 FDAs guidance, Priority Review of Premarket Submissions for Devices, issued on May 17, 2013, implemented 
former section 515(d)(5) of the FD&C Act (as in effect prior to the date of enactment of the 21st Century Cures Act), 
which applied only to PMAs. Because of the potential public health importance of devices warranting priority 
review status, FDA also applied the priority review criteria to other types of premarket submissions for devices.  
FDA withdrew this guidance on August 3, 2017. See https://www.fda.gov/medical-devices/guidance-documents-
medical-devices-and-radiation-emitting-products/withdrawn-guidance.  
16 FDA has discussed expectations for timing of, and the process for, resolving review deficiencies during FDAs 
evaluation of premarket submissions using the interactive review process in the FDA guidance document, Types of 
Communication During the Review of Medical Device Submissions (available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/types-communication-during-review-medical-device-submissions). 
Generally, FDA believes that the principles and concepts described in this Guidance concerning interactive review 
may be relevant for interactions between sponsors and FDA that occur under STeP. 
 
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As with all devices subject to either a PMA or De Novo request, devices in STeP subject to a 
PMA or De Novo request must meet the statutory standard of reasonable assurance of safety and 
effectiveness at the time of PMA approval or granting of a De Novo request. When deciding 
whether to approve a PMA or grant a De Novo request for any device, FDA conducts a benefit-
risk determination as described in the FDA guidance document Factors to Consider When 
Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo 
Classifications.17 As part of the benefit-risk determination, FDA considers the totality of 
evidence regarding the extent of probable benefits and extent of probable risks of a device, 
including the extent of uncertainty in the benefit-risk information. As described in the FDA 
guidance documents, Balancing Premarket and Postmarket Data Collection for Devices Subject 
to Premarket Approval18 and Consideration of Uncertainty in Making Benefit-Risk 
Determinations in Medical Device Premarket Approvals, De Novo Classifications, and 
Humanitarian Device Exemptions,19 FDA intends to use timely postmarket data collection, 
when appropriate for certain submission types, to facilitate expedited and efficient development 
and review and intends to apply these principles for devices in STeP as appropriate.  
 
When making substantial equivalence determinations for devices in STeP subject to premarket 
notification, FDA intends to follow the principles that apply to all devices subject to premarket 
notification as described in the FDA guidance document, The 510(k) Program: Evaluating 
Substantial Equivalence in Premarket Notifications [510(k)]20 and, when appropriate, to apply 
benefit-risk policies in accordance with those described in the FDA guidance document Benefit-
Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 
(510(k)) with Different Technological Characteristics.21 As with devices reviewed under the 
PMA and De Novo pathways, devices in STeP subject to premarket notification must meet the 
applicable statutory standard at the time of 510(k) clearance.    
E.  Efficient and Flexible Clinical Study Design 
As with all medical devices, specific indications or labeling statements regarding clinical benefit 
should be supported by valid scientific evidence, including clinical data, in a manner consistent 
with least burdensome approaches as described in the FDA guidance document The Least 
Burdensome Provisions: Concept and Principles.22 For devices in STeP, FDA intends to 
                                                 
17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-making-
benefit-risk-determinations-medical-device-premarket-approval-and-de. 
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/balancing-premarket-and-
postmarket-data-collection-devices-subject-premarket-approval. 
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consideration-uncertainty-making-
benefit-risk-determinations-medical-device-premarket-approvals-de.   
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k. 
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-factors-consider-when-
determining-substantial-equivalence-premarket-notifications-510k. 
22 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-
concept-and-principles. 
 
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consider proposals for efficient and flexible clinical study designs, including those incorporating 
real world data sources, that may be used to support the proposed indication and/or labeling.23 
F.  Manufacturing Considerations for PMA Submissions 
A device must be in conformance with the Quality System regulation (QS Reg; 21 CFR part 
820), 24 and the sponsor must submit adequate information in a PMA to meet the requirements 
under section 515(c)(1)(C) of the FD&C Act (21 U.S.C. 360e(c)(1)(C)) and 21 CFR 
814.20(b)(4)(v). As with other PMAs, sponsors of a device in STeP should submit PMA 
information as described in the FDA guidance, Quality System Information for Certain 
Premarket Application Reviews.25  
 
For application types that typically require a preapproval inspection (i.e., PMA), FDA intends to 
expedite the review of manufacturing and quality systems compliance, as applicable and as 
resources permit, for devices in STeP using approaches consistent with those established in 
Section II.G of the Breakthrough Devices Program guidance document. 
 
IV.  Factors for STeP Entrance and Review Process 
Inclusion in STeP is only at the request of the sponsor and with FDAs agreement. To request 
entrance into STeP, interested sponsors should first evaluate whether they believe their device, 
which could be a modification to an existing device, meets the general eligibility factor (Section 
IV.A) and the specific program factors (Section IV.B). 
A.  General Eligibility Factor 
To be eligible for STeP, the device should be subject to marketing authorization via the PMA, 
De Novo request, or 510(k) pathways.   
 
As specified in Section I, FDA intends to consider device-led combination products for inclusion 
in STeP. However, as part of the review processes for entrance into STeP, 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.   
 
FDA intends to include devices in STeP if FDA determines that, as described by the sponsor, the 
device meets the general eligibility factor specified here and both of the specific eligibility 
factors identified below.  
                                                 
23 See, for example, the guidance document Use of Real-World Evidence to Support Regulatory Decision-Making 
for Medical Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-
real-world-evidence-support-regulatory-decision-making-medical-devices. 
24 Device-led combination products are subject to different current good manufacturing requirements due to the 
presence of both device and drug or biologic constituents. See 21 CFR Part 4, Subpart A; see also final rule for 
Current Good Manufacturing Practice Requirements for Combination Products, published in Federal Register of 
January 22, 2013 (78 FR 4307). 
25 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-system-information-certain-
premarket-application-reviews. 
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B.  Specific Eligibility Factors  
In order for a device to be included in STeP, it: 
   
1.  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.  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. 
C.  Considerations for Evaluating Specific STeP Eligibility 
Factors 
(1)  First Factor 
The first specific eligibility factor in Section IV.B describes the severity of the disease or 
condition that a device in STeP is intended to address. A central tenet of the Breakthrough 
Devices Program is that only devices that treat or diagnose life-threatening or irreversibly 
debilitating diseases or conditions may be considered for designation based on certain statutory 
criteria.26 FDA recognizes, however, that medical products are used to treat a wide variety of 
health conditions not all of which have such serious morbidities, but which may still negatively 
impact patients health and quality of life. Timely access to safer medical devices for less serious 
conditions is expected to be important in improving health outcomes, and it is these devices that 
are the focus of STeP. Specifically, devices in STeP should be intended to target diseases or 
conditions that would be considered non-life-threatening or reasonably reversible. For example, 
these diseases or conditions could negatively affect patient quality of life or be debilitating for 
short timeframes, such as during post-procedure or post-surgical recovery and/or rehabilitation. 
Additionally, the adverse health consequences associated with these diseases or conditions might 
not significantly impact daily function, and/or they might not progress to a more serious disease 
or condition.  
(2)  Second Factor 
While the first specific eligibility factor considers the severity of the disease or condition the 
device is intended to address, the second factor considers how a device in STeP is expected to 
significantly improve the benefit-risk profile of a treatment or diagnostic compared to 
alternatives for the identified disease or condition. This second eligibility factor encompasses 
several elements including the significance of the anticipated improvement to the benefit-risk 
profile, the type of safety innovation proposed, and whether the device addresses one of four 
specific categories of safety improvement. Below is a discussion of how FDA intends to consider 
                                                 
26 The designation criteria are defined in section 515B of the FD&C Act and described in the Breakthrough Devices 
Program guidance document. 
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each of these elements for the purpose of evaluating the second eligibility factor. 
First, FDA intends to consider whether the device is reasonably expected to provide a significant 
improvement in the benefit-risk profile relative to other available treatment or diagnostic 
alternatives for the disease or condition where there are known serious adverse events and/or 
safety concerns (e.g., as identified in an FDA Safety Communication or medical device recall,27 
or otherwise identified as a significant safety issue of public health importance). FDA intends to 
evaluate the significance of the safety benefit within the context of the overall benefit-risk 
framework for the particular device and proposed intended use, taking into account the intended 
patient population, the severity of the identified safety issue, the severity of the targeted disease 
or condition, as well as other available treatment or diagnostic alternatives. The device should be 
reasonably expected to make a clinically meaningful improvement in the prevalence and/or 
severity of the safety issue typically associated with a particular treatment or diagnostic. FDA 
expects that safety improvements should not compromise the devices effectiveness. 
Additionally, 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 of 
the device in STeP. For example, a modification to a device made for the purpose of realizing a 
safety improvement should not also be reasonably expected to increase the rate of a different 
type of serious adverse event associated with the device or its use. FDA anticipates that requests 
for STeP inclusion will focus on medical devices that are reasonably expected to significantly 
improve safety primarily compared to existing medical devices that are legally marketed in the 
United States. FDA also intends to consider devices for inclusion in STeP that are reasonably 
expected to offer significant safety improvements over the current standard of care, which may 
include FDA-approved drugs or biologics, or other technologies.   
Second, FDA intends to consider whether the expected improvement in the benefit-risk profile is 
through substantial safety innovation. 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. Illustrative examples of innovative technological features 
may include changes to surface physicochemical properties, changes to material manufacturing 
method if those changes facilitate creation of novel device features, or use of a new material with 
an improved safety profile. Similarly, significant modifications to existing software to provide 
new safety functions may also be considered technological innovations for the purpose of this 
evaluation.  
Generally, as part of this evaluation, FDA also intends to consider the principles of operation of 
the device and preliminary data from non-clinical or clinical sources and/or literature analyses. A 
complete dataset of clinical evidence is generally not expected in a request for inclusion in STeP. 
FDA intends to evaluate if there is a reasonable expectation for technical and clinical success of 
the device based on information submitted by the sponsor.   
Finally, FDA intends to consider how the device is reasonably expected to achieve the 
significant improvement to the benefit-risk profile by considering whether the device meets one 
                                                 
27 A collection of medical device safety information can be found at the following link: 
https://www.fda.gov/medical-devices/medical-device-safety. CBER Safety & Availability Communications and 
Recalls may be found at the following links: https://www.fda.gov/vaccines-blood-biologics/safety-availability-
biologics and https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/recalls-biologics.   
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of the following four sub-parts.     
a.  A reduction in the occurrence of a known serious adverse event 
FDA recognizes that, while some medical products do not directly treat or diagnose life-
threatening diseases or conditions, their use may be associated with very serious adverse events 
including patient death or serious injury or illness. These would include serious injuries or 
illnesses that lead to development of life-threatening conditions, disability or permanent damage, 
or subsequent treatment or intervention to prevent permanent impairment or damage.28 To meet 
this sub-part, a medical device should be reasonably expected to result in a significant reduction 
in the occurrence of a known serious adverse event, based on the principles of operation of the 
device. For the purposes of STeP, FDA intends to consider serious adverse events that are 
attributable or reasonably attributed to use of a medical product that occur in acute timeframes 
following treatment or diagnosis (e.g., days to months) as well as those that are associated with 
long term adverse outcomes (e.g., which may occur in the months or years following treatment 
or diagnosis). Examples of medical devices that may meet this sub-part include:  
  A modification to the fundamental principles of operation of an existing device that is 
reasonably expected to significantly reduce or eliminate serious infections,  
  A new implantable device that is reasonably expected to significantly reduce or eliminate 
debilitating symptoms that are known to manifest after implantation of devices of the 
same type, or 
  A new in vitro diagnostic device that is reasonably expected to significantly reduce or 
eliminate the occurrence of serious adverse events associated with a newly approved drug 
that is known to be interfering with the performance of existing in vitro diagnostic 
devices. 
b.  A reduction in the occurrence of a known device failure mode 
For this sub-part, FDA intends to consider whether the medical device seeking entrance into 
STeP is reasonably expected to reduce the occurrence of a known failure mode29 that is likely to 
result in serious adverse health consequences,30 including those that are likely to result in death, 
to be life-threatening, or to involve permanent or long-term injuries to patients. Devices seeking 
entrance into STeP through this sub-part should not be addressing hypothetical device failure 
modes.  
c.  A reduction in the occurrence of a known use-related hazard or 
use error 
Medical devices must meet the applicable statutory standard of safety and effectiveness of the 
device for their intended use(s) and condition(s) of use including, for example, intended users 
and use environments, and manufacturers should design their devices such that they incorporate 
                                                 
28 See serious injury as defined in 21 CFR 803.3(w). 
29 For the purpose of this guidance, failure mode means the manner in which failure occurs and is intended to be 
used within the context of a risk management framework which may include formal failure mode and effects 
analysis (FMEA). See, for example, IEC 60812: Analysis techniques for system reliability  Procedure for failure 
mode and effects analysis (FMEA) and ISO 14971: Medical devices  Applications of risk management to medical 
devices, for additional information.  
30 See serious, adverse health consequence as defined in 21 CFR 810.2(j). 
 
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  Contains Nonbinding Recommendations 
 
features that mitigate use-related hazards or use errors. Generally, use-related hazards and use 
errors result from user operation of, or interaction with, the device and do not represent hazards 
that are consequences of either device or component failure or are inherent to device design or 
material features. FDAs guidance document Applying Human Factors and Usability 
Engineering to Medical Devices,31 defines both use-related hazards and use errors. Use-related 
hazards and use errors that result in serious safety issues can and do occur and may affect not 
only the patient but also the user of the device. In addition to the patient, the user of the device 
may include a clinician or other person directly involved in the administration and use of the 
device. For the purposes of inclusion in STeP, FDA intends to consider medical devices with 
substantial safety innovations that reduce use-related hazards or use errors associated with the 
device design or operational features rather than those associated with inadequate or unclear 
labeling (e.g., instructions for use).   
d.  An improvement in the safety of another device or intervention 
When evaluating this sub-part, FDA intends to consider if the medical device is reasonably 
expected to offer a specific and significant type of improved safety benefit for another medical 
device or intervention. In some cases, this improved safety benefit might come from the medical 
device being evaluated for inclusion in STeP acting as an accessory32 to other medical devices. 
This sub-part may, however, also apply to finished devices that are not accessories. For example, 
a device may meet this sub-part, if the device significantly reduces the risks associated with a 
particular treatment or procedure. Treatment of some pediatric illnesses may require multiple 
surgical interventions throughout the life of a patient, and a device that allows for a single 
intervention instead could be considered to significantly reduce the risks associated with that 
treatment by obviating the need for multiple interventions. Similarly, an innovation that replaces 
the need for invasive sampling or one that replaces an invasive diagnostic procedure with a non-
invasive method may meet this sub-part. 
D.  Additional Considerations for STeP Entrance Review  
(1)  Regulatory Path 
As described in Section III.A, as part of the review process for STeP entrance requests, FDA 
considers whether the planned marketing pathway is a PMA, De Novo request, or 510(k). 
However, a devices inclusion or denied inclusion in STeP does not constitute a formal decision 
regarding the applicable regulatory pathway or device classification. Instead, inclusion of a 
device in STeP indicates that, based on the information provided in the request and other 
information known at the time, the Agency expects that submission of a PMA (or PMA 
supplement), 510(k), or De Novo request will be necessary for marketing authorization. When 
communicating whether a device has been included or denied inclusion in STeP, FDA does not 
                                                 
31 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-
usability-engineering-medical-devices. 
32 Medical device accessories are defined in the FDA guidance document entitled Medical Device Accessories  
Describing Accessories and Classification Pathways (available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-
pathways) as a finished device that is intended to support, supplement, and/or augment the performance of one or 
more parent devices.   
 
11 
  Contains Nonbinding Recommendations 
 
intend to specify which type of marketing submission the sponsor will need to submit for the 
device.  
 
Additionally, some, but not all, medical devices included in this program that are intended to 
improve the safe use of another device under specific eligibility Factor 2d may be accessories to 
other devices. Inclusion of a device into STeP does not constitute a decision on whether the 
device is an accessory or on its risk classification. Please refer to FDAs guidance document 
Medical Device Accessories  Describing Accessories and Classification Pathways33 for a 
discussion of how FDA evaluates whether a medical device is an accessory as well as the 
classification processes for devices that are considered accessories. 
 
STeP is predicated upon expediting the development and review of medical devices that are 
reasonably expected to address significant safety issues associated with available treatments or 
diagnostics. Therefore, the safety improvement planned for the STeP device is relative to 
available technologies for treating or diagnosing the same disease or condition. FDA recognizes 
that many of the medical devices ultimately included in STeP are expected to offer safety 
improvements as compared to the use of other medical devices. Changes to a medical device that 
are intended to affect its safety profile and/or mitigate known safety issues are likely to require 
approval of a new PMA or PMA supplement,34 granting of a new De Novo request, or clearance 
of a new 510(k).35 As described in the FDA guidance document Deciding When to Submit a 
510(k) for a Change to an Existing Device,36 FDA anticipates that changes made to 510(k) 
devices intended to significantly affect safety, as is the intent of STeP, will require a new 
premarket submission to the FDA. The substantial equivalence evaluation in a 510(k) will not be 
impacted by inclusion of the device in STeP. However, proposed modification(s) may raise 
different questions of safety or effectiveness as compared to the unmodified version or other 
predicates. If the device cannot be found substantially equivalent through the 510(k) process,37 
the sponsor may choose to pursue marketing through either a PMA or De Novo request.38  
                                                 
33 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-
describing-accessories-and-classification-pathways. 
34 The criteria for determining what type of application mechanism is needed when making device design or 
manufacturing changes to lawfully marketed PMA devices are described in 21 CFR 814.39 and elaborated on in the 
FDA guidance document entitled Modifications to Devices Subject to Premarket Approval (PMA) - The PMA 
Supplement Decision-Making Process, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-supplement-decision-making-
process.  
35 See FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device. 
36 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device.  
37 The framework for FDAs evaluation of substantial equivalence in 510(k) submissions is described in detail in the 
guidance document entitled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)], available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k. 
38 See also https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma and De Novo 
Classification Process (Evaluation of Automatic Class III Designation), available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-
evaluation-automatic-class-iii-designation. 
 
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  Contains Nonbinding Recommendations 
 
 
Inclusion of a modified device into this program will not impact the obligations or 
responsibilities of a manufacturer with respect to any recall or correction (e.g., reporting 
requirements under 21 CFR 806). Please refer to the FDA guidance document Distinguishing 
Medical Device Recalls from Medical Device Enhancements, which provides additional 
considerations for these types of device changes.39  
 
Finally, participation in STeP does not change or impact the statutory and regulatory 
requirements applicable to a medical device. FDAs evaluation of a STeP entrance request into 
the program is limited to whether the product meets the eligibility factors described herein. 
Therefore, inclusion in the program should not be interpreted as a decision on the relative or 
absolute safety or effectiveness of that medical device, or any other medical products. Rather, the 
program provides an opportunity for early and regular interaction with FDA as device 
development and review unfold. When a device is included in STeP, the available information 
suggests that there is a reasonable expectation that the device may significantly improve the 
benefit-risk profile of a treatment or diagnostic through substantial safety innovations. As 
described above, FDA intends to expedite the development and review of the device so that the 
potential safety innovation can be available to patients in a timely manner. Under STeP, the 
device is not designated, deemed, or otherwise categorized as a safe or safer technology. As 
with all medical devices subject to review under a PMA, De Novo request, or 510(k), FDA 
determines whether a device in STeP meets the applicable statutory standard of safety and 
effectiveness for use under the conditions prescribed, recommended, or suggested in the devices 
proposed labeling submitted with the marketing submission.40   
(2)  Timeframe for STeP Entrance Request 
Ideally, sponsors should submit a request for inclusion in STeP prior to FDA receipt of the 
marketing submission for that device.  Additionally, FDA may consider requests for inclusion in 
STeP in parallel with a marketing submission or after a marketing submission has been 
submitted. It should be noted, however, that devices included in STeP during review of the 
marketing submission may not benefit from programmatic features to the same extent as those 
devices for which requests for inclusion in the program occur earlier in their development 
process.  
(3)  Multiple Devices for the Same Expected Safety Benefit 
FDA might include multiple devices in STeP that are intending to address the same safety issue 
or improvement. As a consequence, multiple regulatory submissions for devices intending to 
address the same safety issue may be pending simultaneously.  
 
FDA recommends that each request for inclusion in STeP be limited to one device intending to 
address a significant safety concern(s). 
                                                 
39 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/distinguishing-medical-device-
recalls-medical-device-enhancements. 
40 See FDAs guidance document Medical Product Communications That Are Consistent With the FDA-Required 
Labeling  Questions and Answers, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/medical-product-communications-are-consistent-fda-required-labeling-questions-and-answers.  
13 
  Contains Nonbinding Recommendations 
 
E.  Submitting a Request for Inclusion in STeP and FDA 
Review 
Requests for inclusion in STeP should be submitted using the Q-submission process as described 
in the FDA guidance document Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program (hereinafter, the Q-Submission Guidance).41  
Requests for program inclusion should be sent to the Document Control Center at CDRH or 
CBER as applicable for the regulation of the device.42 A sponsor intending to request inclusion 
in STeP should submit a Q-submission package containing the recommended information as 
described in Appendix 1: Illustrative Example of a Request for Inclusion in STeP. The 
inclusion request should be the only request contained in the Q-Submission. Requests for 
feedback on the device outside of the STeP entrance request should be submitted separately. 
Furthermore, if sponsors are requesting inclusion in STeP and at the same time have other 
requests for feedback pending, they may wish to consider submitting those additional questions 
after FDA includes or denies inclusion of a device in STeP as FDAs feedback may incorporate 
STePs additional programmatic features. In addition, note that requests for inclusion in STeP 
should be submitted separately from the submission of a marketing submission or IDE 
application. 
 
FDA intends to include or deny inclusion of a device in STeP within 60 calendar days of receipt 
of the request for inclusion. In general, FDA intends to interact with a sponsor within 30 calendar 
days of receipt regarding any requests for additional information needed to evaluate the request. 
A request for additional information does not place the STeP entrance request on hold, and FDA 
does not plan to stop the 60-day review window during interactions to obtain additional 
information. The sponsor should respond within the timeframe stipulated in the additional 
information request by submitting an amendment to the Q-submission. It is helpful when a 
sponsor is available and responsive to FDA requests throughout FDAs review. FDA intends to 
interact with the sponsor using communication tools such as email or telephone.43 If FDA does 
not receive additional information needed to evaluate a STeP request in a timely manner, it may 
result in denial of the request for inclusion in STeP.  
F.  Withdrawal and Disqualification from STeP After 
Program Inclusion 
A sponsor may request to withdraw from STeP at any time. Such a request should be submitted 
in writing to FDA as a withdrawal amendment to the Q-submission number under which 
                                                 
41 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
42 See FDAs guidance document eCopy Program for Medical Device Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
43 For additional information about email communications with CBER, please see SOPP 8119: Use of Email for 
Regulatory Communications, available at 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm1
09645.htm. CBER will accommodate the use of faxes. 
 
14 
  Contains Nonbinding Recommendations 
 
inclusion in STeP was requested. 
FDA does not intend to disqualify a device from further participation in STeP on the basis of 
another STeP device that was intended to address the same safety issue receiving PMA approval, 
having a De Novo request granted, or receiving clearance of a 510(k).44 However, FDA may 
disqualify a device from further participation in STeP at any time upon written notice to the 
sponsor if FDA determines that: 
  for other reasons, the device is no longer eligible for STeP based on available 
information; or 
  the information submitted in support of a request for inclusion in STeP, including, 
without limitation, the Q-submission requesting inclusion in STeP or any related 
premarket submission, contained an untrue statement of material fact or omitted material 
information, including false statements relating to data collection. 
 
V.  Mechanisms for Feedback on Development of Devices 
in STeP 
To facilitate an interactive and expedited approach to device development and similar to features 
outlined for devices granted Breakthrough designation, as resources permit, FDA intends to offer 
sponsors of devices included in STeP several voluntary options for early and regular interaction 
with FDA as device development progresses. A sponsor who wishes to request feedback on a 
device that has been included in STeP may select one or more of the options described below in 
Sections A-C and submit it to FDA through the Q-Submission process referencing the request as 
a STeP interaction submission. Use of these options is not mandatory.  
The options available for STeP include (1) a sprint discussion (See Section V.A), and (2) review 
of a Data Development Plan (DDP) (See Section V.B). We consider these options to be subsets 
of pre-submissions. When submitting a request for feedback on a device included in STeP, 
sponsors should specify if they are requesting one of these special program features available to 
facilitate the expedited review. Additionally, sponsors of devices included in STeP also have the 
option to request feedback from FDA through mechanisms that are available for devices, 
generally. For example, they may submit traditional pre-submissions whose scope is more 
consistent with typical requests for feedback received through the Q-Submission Program 
(Section V.C).  FDA intends to follow the approaches and review procedures for these optional 
mechanisms for feedback as outlined in Section IV. of the Breakthrough Devices Program 
guidance document.  
The regulatory mechanisms described in this section for obtaining FDA feedback on devices in 
STeP may also be used for device-led combination products included in the program. However, 
it is important to note these products may raise additional scientific challenges which could 
influence the feedback that FDA provides. Interactive review of complex scientific issues 
requiring expertise from a different Center may require additional time to resolve. When CDRH 
or CBER receives a Q-submission, IDE, or marketing submission for a device-led combination 
                                                 
44 This policy is consistent with program requirements for the Breakthrough Devices Program as required by section 
515B(d)(3) of the FD&C Act (21 U.S.C. 360e-3(d)(3)). 
15 
  Contains Nonbinding Recommendations 
 
product that has been included in STeP, CDRH or CBER intends to notify the consulting 
Center(s) of its receipt. Furthermore, the appropriate review staff from the consulting Center(s) 
should be included in relevant meetings to ensure that the entire combination product review 
team is aware of the issues discussed and that they are engaged, as needed, in the review.45  
Sponsors should recognize that, even though the FDA may have already reviewed the sponsors 
protocols/plans in a sprint discussion, DDP, or pre-submission, this does not guarantee approval, 
clearance, or granting of future marketing submissions. Additional questions may be raised 
during the review of the future submission when all information is available and considered as a 
whole. Although sprint discussions, DDP reviews, and pre-submissions are not decisional or 
binding on the Agency or the sponsor, it is FDAs intent to provide the best advice possible 
based on the information provided by the sponsor and other information known at that point in 
time. 
FDA intends that the feedback the Agency provides in response to DDP requests, as part of a 
sprint discussion, or through the pre-submission process will not change, provided that the 
information submitted in a future IDE or marketing submission is consistent with that provided 
in the feedback request and that the data in the future submission do not raise any important new 
issues materially affecting safety or effectiveness. FDA intends that modifications to its feedback 
be limited to situations in which FDA concludes that the feedback given previously does not 
adequately address important new issues materially relevant to a determination of safety or 
effectiveness that have emerged since the time the feedback was provided. For example, FDA 
might modify its previous feedback if new scientific findings emerge that indicate there is a new 
risk or an increased frequency of a known risk that affects FDAs prior advice, or if there is a 
new public health concern that affects FDAs prior advice. In such cases, FDA intends to 
acknowledge a change in the advice and clearly document the rationale for the change and the 
appropriate managerial concurrence. 
A.  Sprint Discussion 
To support sponsors needing timely resolution of non-clinical or clinical evaluation issues, FDA 
offers sprint discussions with the goal of reaching mutual agreement on a specific topic within 
a set time period (e.g., 45 days) which FDA intends to expedite from the review timelines for 
traditional pre-submissions46 as resources permit. The number, format, and duration of 
interactions within a sprint discussion may vary based on project needs and should be defined a 
priori by the sponsor and FDA. FDA recommends that sponsors limit the content of the sprint 
request to one general topic (e.g., animal study protocol) and specific goals thereof.   
During an open sprint review period, FDA recommends that the sponsor email draft meeting 
minutes to FDA for comment and inclusion in the administrative record for the sprint 
                                                 
45 While the lead Center is the primary contact point for combination product sponsors, OCP is available to 
participate in meetings or otherwise engage on regulatory matters for these products upon request (see section 
503(g)(8) of the FD&C Act, 21 U.S.C. 353(g)(8)). For further information on combination products and OCP, see 
the OCP webpage at https://www.fda.gov/CombinationProducts/default.htm. 
46 Review timelines for Pre-Submissions are described in the FDA guidance document entitled Requests for 
Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
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  Contains Nonbinding Recommendations 
 
submission. Following closure of a sprint discussion, sponsors may additionally submit a formal 
meeting minutes Q-submission amendment to FDA for review that documents all of the 
teleconferences and/or face-to-face meetings held throughout the sprint review. To submit the 
formal meeting minutes Q-submission amendment, sponsors should use the process described in 
the Q-Submission Guidance. FDA intends to follow the timeline and procedures established for 
other meetings under the Q-Submission Program when reviewing formal meeting minutes Q-
submission amendments.  
Additional information regarding the general conduct of a sprint discussion and example formats 
are included in Section IV.A of the Breakthrough Devices Program guidance document.   
B.  Data Development Plan (DDP) 
Sponsors of devices in STeP may request coordination with FDA regarding review of a DDP. 
The DDP is an optional, high-level document intended to help ensure predictable, efficient, 
transparent, and timely device assessment and review by outlining data collection expectations 
for the entire product lifecycle. The DDP may include either clinical evaluation strategies, non-
clinical testing approaches, or both, as well as the anticipated timeframe for submitting results of 
these evaluations to FDA for review (e.g., in an IDE application for a pivotal study). While the 
optimal timeframe for submission of a DDP will vary depending on the device, it may be most 
beneficial to initiate DDP discussions with FDA soon after inclusion in STeP. For additional 
information on DDPs, please refer to Section IV.B and Appendix 2 of the Breakthrough Devices 
Program guidance document. FDA encourages sponsors to consider the non-clinical testing that 
will be needed to support the regulatory review of their device early in development and to 
discuss the planned approach with FDA. Additionally, sponsors of devices included in STeP may 
outline in their DDP any proposals to evaluate the clinical impact of safety improvements that 
balance the amount of data collected pre- and post-market for PMAs.   
FDA review of a DDP may follow a similar model as the sprint discussion described above and, 
like sprint discussions, is not subject to an acceptance review. In general and as resources permit, 
FDA anticipates that feedback on a DDP will be provided in less time than would be expected 
for a traditional pre-submission. 
C.  Other Pre-Submissions for STeP Devices 
FDA recognizes that some sponsors of devices included in STeP may wish to engage with FDA 
on a broader scope of topics in a single pre-submission than may be discussed in one of the 
options presented above in Sections V.A and B. For these requests, the sponsor may submit a 
pre-submission as described in the Q-Submission Guidance and specify that it is for a device 
included in STeP. Review teams should work with the sponsor to develop an appropriate 
timeline for feedback, which may be shorter than review timelines for traditional pre-
submissions,47 when possible and as resources permit. 
                                                 
47 Review timelines for Pre-Submissions are described in the FDA guidance document entitled  Requests for 
Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
17 
  Contains Nonbinding Recommendations 
 
D.  Regular Status Updates 
FDA and the sponsor of devices included in STeP may agree to have regular (e.g., bimonthly, as 
resources permit) status updates outside of a formal regulatory submission to the Agency. 
Through these interactions, FDA and the sponsor may discuss general progress of the project 
(e.g., timeframe for a planned marketing submission) and next steps or plans for future 
discussions. Importantly, FDA believes that regular status updates provide an opportunity for a 
high-level view of the project and identification of potential hurdles, while a sprint discussion, DDP, 
or traditional pre-submission provides the opportunity for detailed feedback to address specific 
sponsor goals.  For more information regarding status updates, please refer to Section IV.E of the 
Breakthrough Devices Program guidance document.  
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  Contains Nonbinding Recommendations 
 
Appendix 1: Illustrative Example: Recommended Contents 
of a Q-Submission Request for Inclusion in STeP 
This appendix outlines the recommended information that should be included in a Q-submission 
requesting inclusion in STeP. 
Background Information 
Device Description: This section should provide an overview of the device or device-led 
combination product (including device, drug, and/or biologic constituent parts), including 
principles of operation and properties relevant to clinical function, if known. Images or 
engineering schematics are also encouraged for inclusion, as appropriate.   
Expected Safety Improvement: This section should provide a clear description of the safety issue 
that the device is intending to address and rationale for the seriousness of the adverse events 
associated with the safety issue. Additionally, the sponsor should describe any technological 
advances or features of the device intended to improve safety. 
Indications for Use: This section should present the sponsors proposed indications for use. If the 
sponsor plans on including specific claims related to safety improvement, those claims should be 
included as well.     
Regulatory History: This section should detail the history of previous FDA interactions and 
submissions, including feedback received and resolution of that feedback, as applicable. All 
relevant IDE, 513(g),48 and Q-submission numbers should be included. If a Request for 
Designation (RFD), or pre-RFD, was submitted to OCP for the product, such information should 
also be included. 
Justification for Meeting General Eligibility Factor 
What is the planned marketing submission? 
  PMA; 
  De Novo request; or 
  510(k). 
This section should provide a discussion of which marketing submission the sponsor plans to 
submit for the device, including a rationale for such selection. Only one submission type should 
be selected.  
 
                                                 
48 See FDAs guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the 
Federal Food, Drug, and Cosmetic Act, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-
cosmetic. 
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  Contains Nonbinding Recommendations 
 
Justification for Meeting Specific STeP Eligibility Factors 
Eligibility Factor 1: The device seeking inclusion in STeP is not eligible for the Breakthrough 
Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or 
prevented by the device. 
This section should provide a discussion regarding how the Eligibility Factor 1 is met by the 
proposed device and indications for use. 
Eligibility Factor 2: The device seeking inclusion in STeP is 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. 
This section should provide a discussion of which sub-part(s) of Eligibility Factor 2 is/are met by 
the proposed device and indications for use. Please note that multiple sub-parts of Factor 2 may 
apply; however, meeting only one of these sub-parts would still support inclusion in STeP if the 
other eligibility factors are otherwise met. For each sub-part of Eligibility Factor 2 identified as 
being met, a discussion regarding how that sub-part is met should be included in the request for 
inclusion in STeP. 
 
20