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Safety and Performance Based 

Pathway Criteria for Certain Device 

Types

Jason Ryans, Ph.D.

Technical Guidance Specialist

Regulation, Policy & Guidance Staff

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

September 24, 2020
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• Objectives

• Background

• Device-specific performance criteria final guidances

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

• Future plans

• Opportunities for stakeholder engagement

• Q&A

Agenda
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Objectives

• Provide an overview of recently issued device-specific final guidances and 

how to use them

• Outline operationalization of Safety and Performance (S&P) Based 

Pathway
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Timeline

• February 2019 – Safety and Performance Based Pathway final guidance issued

• September 2019 – First 4 device-specific draft* guidances issued

• November 2019 – Safety and Performance Based Pathway Framework Webinar 

• December 2019 – Magnetic Resonance Coil Performance Criteria draft* guidance 

issued

• February 2020 – Soft (Hydrophilic) Daily Wear Contact Lenses draft* guidance issued

• August 2020 – First 2 device-specific final guidances issued

*Draft guidance – Not for implementation purposes
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• Voluntary 510(k) pathway for well-understood Class II devices that 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 low to moderate risk devices

Safety and Performance (S&P) Based Pathway 
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• Appropriate devices are identified with the scope of each guidance

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

• Cross-cutting recommendations largely the same and consistent with previous 

subject guidance(s)

– Biocompatibility, sterility, electrical safety, etc. 

• Only final (not draft) device-specific guidances can be implemented for the S&P

pathway

• Initial device-specific performance criteria for S&P pathway final guidances

– Conventional Foley Catheters

– Cutaneous Electrodes for Recording Purposes

Device-Specific Guidances
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• FDA intends to identify the performance criteria for each device type eligible for 

the S&P Pathway in guidance

• FDA intends to recommend testing methods where feasible 

• FDA intends to ensure that criteria represent performance levels that are at 

least equivalent to the performance of legally marketed devices 

Performance Criteria
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• Derived from multiple sources including:

– FDA-recognized consensus standards

– FDA guidance

– Special Controls

– Scientific literature

– Historical 510(k) submission data

• Only performance criteria in FDA-recognized consensus standards that have 

been identified in FDA Safety and Performance Based Pathway device-specific

guidance can be used in the S&P pathway

Performance Criteria (cont.)
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Device-Specific Final Guidance Example

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway
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Example – Foley Catheter Scope

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway

II. Scope/Device Description

The Foley catheters that are the subject of this guidance are intended for the drainage and/or 

irrigation of the urinary tract. These devices are Class II and are regulated under 21 CFR 876.5130 

with the product code EZL (Catheter, Retention Type, Balloon).

Intended Use/Indications for Use:

Drainage is accomplished by inserting the catheter through the urethra into the bladder. The 

catheter is retained by the use of a balloon inflated in the bladder, which is attached to the distal 

end of the catheter. The devices are single-use and indwelling time should be 30 days or less.

Device Design Characteristics:

The French sizes within the scope of this guidance include sizes 12 through 26 with a retention 

balloon volume no greater than 30 cm3. Two lumen catheters are included within the scope of this 

guidance. Three lumen catheters, catheters treated to enhance their lubricity, suprapubic catheters, 

and antimicrobial catheters are outside the scope of this guidance.
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Example – Foley Catheter Performance Test

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway

2. Test name: Flow Rate

Methodology: ASTM F623 Standard Performance Specifications for Foley 

Catheters

Performance Criteria: Catheters with French size 14-26 should have a 

minimum average flow rate of 100 cm3/min. French size 12 catheters should 

have a minimum average flow rate of 70 cm3/min.

Performance Criteria Source: ASTM F623 (2019) Standard Performance 

Specifications for Foley Catheters

Additional Considerations: ASTM F623 does not provide a criterion for 

French size 13 catheters as conventional Foley catheters typically have an 

even numbered French size.

Submission Information: Declaration of Conformity (DoC)
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Example – Foley Catheter Biocompatibility

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway

Biocompatibility Evaluation

To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation you 

should use Attachment A of CDRH’s guidance Use of International Standard ISO 10993-1, Biological 

evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, 

referred to in the rest of this document as the CDRH Biocompatibility Guidance for brevity. FDA 

considers the devices covered by this guidance to be categorized as “External Communicating Devices” 

with a “prolonged” tissue contact duration of >24 hours to 30 days and you should assess the endpoints 

below per Attachment A of the CDRH Biocompatibility Guidance.

• Cytotoxicity

• Sensitization

• Irritation or Intracutaneous Reactivity

• Acute Systemic Toxicity

• Material-Mediated Pyrogenicity (should be conducted to support devices labeled as “non- pyrogenic”)

• Sub-acute/Sub-chronic Toxicity

• Genotoxicity

• Implantation
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• New device should be within the scope of a device-specific performance criteria 

final guidance

• The new device meets all of the identified criteria

– Unique to this pathway, all criteria must be met in order to be eligible

• Identification of an appropriate predicate is still necessary

Submitting 510(k): Is The Device Appropriate?
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• 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

Submitting 510(k): Are Performance Criteria Met?
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• Same MDUFA 90 day review clock, like for Traditional and Abbreviated 

510(k)

• Same MDUFA user fees

• Recommend cover letter state that the 510(k) submission is for the Safety 

and Performance Based Pathway

510(k) Submission to the S&P Pathway
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• Refuse to Accept (RTA) similar to Abbreviated 510(k)

– Consistent with Refuse to Accept Policy for 510(k)s Guidance

• Potential for conversion to Traditional 510(k)

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

510(k) Submission to the Pathway (cont.)
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• Pre-Submission

– Can be used to determine if device is appropriate for the S&P Pathway

– 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

Questions About The S&P Pathway?
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• Submit comments or suggestions

– On device-specific guidances with device-specific feedback or general 

programmatic feedback

– Device types well-suited for inclusion in S&P pathway to programmatic final 

guidance docket (FDA-2018-D-1387)

– Standardized methods and criteria for the FDA to evaluate

Stakeholder Engagement
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• Safety and Performance Based Pathway webpage

• Safety and Performance Based Pathway final guidance

• November 2019 Safety and Performance Based Pathway webinar

• 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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• Draft* Device-specific guidances

– Orthopedic Non-Spinal Metallic Bone Screws and Washers

– Spinal Plating Systems

– Magnetic Resonance (MR) Coils

– Soft (Hydrophilic) Daily Wear Contact Lenses

• Final device-specific guidances

– Conventional Foley Catheters

– Cutaneous Electrodes for Recording Purposes

Resources (cont.)

*Draft guidance – Not for implementation purposes
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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: 

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