Welcome to today’s 

FDA/CDRH Webinar

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U.S. Callers: 888-945-5893 

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Conference Number: PWXW9528798

Passcode: 5705130 
Safety and Performance Based 

Pathway

Jason Ryans, Ph.D.

Technical Guidance Specialist

Regulation, Policy & Guidance Staff

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

November 7, 2019
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• Objectives

• Background

• Safety and Performance Based Pathway final guidance

• Device-specific performance criteria draft guidances

• 510(k) submission to Safety and Performance Based Pathway

• Future plans

• Opportunities for stakeholder engagement

Agenda
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Objectives

• Provide an overview of the Safety and Performance Based 

Pathway

• Outline content and use of device-specific guidance documents
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Initiatives to Enhance 

Device Safety

• April 2018 - Medical Device Safety 

Action Plan released

• November 2018 – Joint statement by 

Drs. Scott Gottlieb and Jeffrey Shuren

─ Modernizing the 510(k) Pathway

─ Promoting greater transparency 

and post-market surveillance
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• The 510(k) program has undergone a number of statutory 

changes since its inception 

• The U.S. Food and Drug Administration (FDA) has adapted its 

implementation of the program in response to changing statutory 

requirements and the evolving medical device landscape 

Current 510(k) Program
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway

Final Guidance
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• Voluntary 510(k) pathway for certain well-understood FDA-specified 

Class II devices to gain clearance for marketing based on demonstrating 

they meet specified performance criteria

• Device would meet FDA-identified performance criteria used to 

demonstrate substantial equivalence

• Direct and transparent approach to demonstrating the safety and 

effectiveness of certain, well understood devices

Safety and Performance Based Pathway 
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• Through guidance, the FDA will identify the performance criteria 

for each device type appropriate to be reviewed through the 

Safety and Performance Based Pathway, as well as the testing 

methods recommended where feasible, and any other relevant 

information. 

• The FDA will ensure that these criteria represent performance 

levels that are at least equivalent to the performance of legally 

marketed devices of the type to which they apply. 

Performance Criteria
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• Performance criteria may be derived from multiple sources 

including FDA-recognized consensus standards, the FDA’s 

guidance, scientific literature, and historical 510(k) submission 

data. 

• Performance criteria in FDA-recognized consensus standards 

that have not been identified in a Safety and Performance Based 

Pathway device-specific guidance should not be used in this 

pathway. 

Performance Criteria (cont.)
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• The new device should meet all of the identified criteria

– Unique to this pathway

• Identification of an appropriate predicate is still necessary

• Performance criteria are appropriate when:

– Indications and technical characteristics do not raise different 

questions of safety and effectiveness than the predicate

– Performance criteria align with one or more predicates of the 

same device type

– The new device meets all of the identified criteria in devicespecific S&P guidance

Using the Safety and Performance Based 

Pathway
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Using the Safety and Performance Based 

Pathway (cont.)

• Indications and technical characteristics do not raise different questions of 

safety and effectiveness than the predicate

– Focus on the decision point that requires a 510(k) submitter to 

demonstrate that, despite technological differences, its device is as safe 

and effective as a legally marketed device

– Ensure the criteria are appropriate by clarifying the set of devices for 

which the performance criteria are appropriate in guidance and having 

submitters identify a predicate of the same device type
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Review of Data

1) Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

2) Recommended Content and Format of Non-clinical Bench Performance Testing Information in Premarket 

Submissions
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• Currently 4 device-specific draft guidances with more in development

• Pathway will not be implemented until at least one guidance is finalized

• Criteria development

– When possible, we reference existing FDA-recognized standards for 

both methodology and performance criteria

– When historical 510(k) data is used, the FDA intends to look at recent 

predicates to establish the performance of more modern devices and 

technologies

– Some criteria may be qualitative, such as biocompatibility

Device-specific Performance Criteria 

Guidances
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• Appropriate devices are limited to scope of guidance

– Classification Regulation, product code, indications for use, etc.

• Cross-cutting recommendations largely the same and consistent with 

current cross-cutting guidance(s)

– Biocompatibility

– Sterility 

– Reprocessing

– Electrical Safety and Electromagnetic Compatibility

– Software

Device-specific Performance Criteria 

Guidances (cont.)
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• The FDA intends to maintain a list of device types on our 

website, accompanied by links to associated guidances

• The FDA intends to revise the list to add or remove device 

types and may revise performance criteria and testing 

methodology over time as necessary

– Periodic review of the applicable criteria and guidances to 

ensure they remain contemporary

Safety and Performance Device Type 

List Modifications
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• May modify or remove an entry from the list, particularly where 

new information indicates that the performance criteria in the 

identified guidance do not fully support a substantially equivalent 

(SE) determination 

• Changes to the list, such as, when a device type is removed 

from the list or an updated final guidance is issued, would apply 

prospectively to devices for which a 510(k) has not yet been 

submitted 

Safety and Performance Device Type 

List Modifications (cont.)
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• Pre-Submission

– Can be used to determine if device is appropriate for the pathway

– On a case-by-case basis and if otherwise in scope, can be used if you 

determine there is additional testing outside of the guidance that is 

necessary to demonstrate safety and performance of the device

• Refuse to Accept (RTA) similar to Abbreviated 510(k)

– Consistent with Refuse to Accept Policy Guidance

• 90-Day Review clock

• Substantive Interaction same as Traditional and Abbreviated 510(k)

510(k) Submission to the Safety and 

Performance Based Pathway
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• Receive and consider comments to public dockets

• Finalize the first set of technical device-specific 

performance guidances to implement the pathway

• Continue development of device-specific draft 

guidances across the Center for Devices and 

Radiological Health (CDRH)

Future Plans
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• Stakeholders including the FDA, patient groups, and industry 

should collaborate to:

– Identify device types that may already be a good fit for the 

pathway

– Collaborate to facilitate the FDA’s recognition of standards by 

identifying methods or criteria that are acceptable

– Identify gaps or challenges that may limit the appropriateness 

of device types

– Harmonize with other regulatory jurisdictions if they have 

established methods or criteria that could be utilized, but are 

not currently

Stakeholder Engagement
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• Submit comments on device-specific guidances with devicespecific feedback or general programmatic feedback

• Submit suggestions of device types well suited for inclusion in 

pathway, as well as suggestions of standardized methods and 

criteria for the FDA to evaluate, to Safety and Performance Based 

Pathway final guidance docket: 

FDA-2018-D-1387

Stakeholder Engagement (cont.)
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• Safety and Performance Based Pathway Webpage

• Safety and Performance Based Pathway final guidance

• Draft Device-specific guidances

– Cutaneous Electrodes for Recording Purposes

– Conventional Foley Catheters

– Orthopedic Non-Spinal Metallic Bone Screws and Washers

– Spinal Plating Systems

• Recommended Content and Format of Non-clinical Bench Performance Testing Information 

in Premarket Submissions

• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 

Devices

Resources
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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; 

Subheading: Premarket Notification