FDA Webinar 

Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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FDA Webinar: Safety and Performance Based Pathway 

Criteria for Certain Device Types Final Guidances 

Moderator: Irene Aihie

September 24, 2020 

1:00 pm ET 

Coordinator: Welcome and thank you for standing by. At this time all participants will be 

on a listen-only mode until the question-and-answer session of today's 

conference. To ask a question from the phone lines please press star 1 and 

record your name at the prompt. Objections, please disconnect at this time. 

Irene Aihie: Thank you. Hello. And welcome to today's FDA webinar. I am Irene Aihie of 

CDRH's Office of Communications and Education. On August 13, 2020, the 

FDA issued two final guidance documents providing performance criteria for 

specific device types in support of the safety and performance-based pathway. 

As part of our commitment to strengthening and modernizing the 510(k) 

program, the FDA announced in February 2019, the framework for this 

voluntary safety and performance-based pathway through final guidance. 

These guidance's allow for implementation of the safety and performancebased pathway and provide an alternative 510(k) pathway for certain Class 2 

moderate risk devices to gain clearance for marketing, by demonstrating that 

they meet modern performance criteria identified by the FDA. 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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Today, Jason Ryans, Technical Guidance Specialist in the Office of Product 

Evaluation and Quality here in CDRH, will present his overview of the final 

guidance documents. He is joined by other center subject matter experts to 

assist with the Q&A portion of this webinar. Following the presentation, we 

will open the line for your questions related to information provided during 

the presentation. 

Now I give you Jason. 

Jason Ryans: Thank you, Irene and good afternoon to everyone joining us. Today's webinar 

will provide an overview of the device-specific performance criteria final 

guidances that were issued in August of this year. This will allow the first 

device types to be submitted to the safety and performance-based pathway. 

Additionally, we will discuss some of the aspects related to submitting a 

510(k) to this pathway. Next slide, please. 

The agenda for today's webinar includes a review of the objectives for today's 

presentation, some background information on the safety and performancebased pathway, a walkthrough of the different sections of the device-specific 

performance criteria final guidance, a discussion about what should be 

considered when submitting a 510(k) to the safety and performance-based 

pathway, a brief look at FDA's future plans for the pathway, and potential 

opportunities for stakeholder engagement. Next slide, please. 

The objectives for this presentation are to walk through a device-specific 

performance criteria final guidance, and discuss how these guidances should 

be used for this pathway. This talk will also go over aspects of submitting a 

510(k) to the safety and performance-based pathway, also called the S&P 

pathway. Next slide, please. 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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First, I would like to go over some of the progress that we've made in 

establishing the safety and performance-based pathway. In February 2019 

FDA issued the safety and performance-based pathway final guidance. This 

acted as a programmatic guidance for the pathway and outlined the general 

framework and policies of the pathway. 

In September 2019 we issued the first four device-specific performance 

criteria draft guidances. A listing of the device-specific guidances can be 

found on FDA's Web page for the safety and performance-based pathway that 

is included in the references at the end of this presentation. These guidances 

outline the methods and criteria that should be met to submit a 510(k) to this 

pathway. 

It is important to note that draft guidances are not for implementation and 

cannot be utilized for this pathway until the final version is issued. In 

November of 2019 a webinar was presented outlining the general framework 

and policies of the pathway. I would encourage you, those of you looking for 

additional information, regarding the programmatic guidance, to check out 

that webinar. 

In December 2019 and February 2020 we issued additional device-specific 

performance criteria draft guidance for magnetic resonance coils and soft 

daily wear contact lenses. Then recently in August, we issued the first two 

device-specific performance criteria final guidances, which include 

conventional Foley catheters and cutaneous electrodes for recording purposes. 

Again, with these two final guidances issued, it is now possible to submit a 

510(k) to the pathway for these particular device types. Next slide, please. 

The purpose of this pathway is to establish a voluntary, more modern 510(k) 

pathway to demonstrate the safety and effectiveness for certain well-
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09-24-20/12:00 pm ET 

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understood devices. To facilitate a more modern paradigm, FDA expands 

upon the abbreviated 510(k) pathway to allow manufacturers of certain wellunderstood device types to use objective performance criteria established or 

recognized by the agency to demonstrate substantial equivalence. 

Importantly, the safety and performance-based pathway is optional and will 

not impede the use of other 510(k) pathways including the traditional, special 

and abbreviated. In this new pathway submitters will demonstrate that a new 

device meets FDA-identified performance criteria to demonstrate that the 

device is as safe and effective as a legally marketed device. Overall, the goal 

is to facilitate an approach that would provide more direct evidence of the 

safety and effectiveness of a device in a more straightforward and streamlined 

manner. Next slide, please. 

To identify which device types are appropriate for the pathway, FDA will 

include information in the scope of each device-specific guidance such as the 

regulation, product code, device characteristics, intended use, and/or 

indications for use. Additionally, FDA-identified devices may be a subset of a 

particular regulation or product code. To ensure a least burdensome 

assessment of certain evaluations, many crosscutting recommendations such 

as biocompatibility and sterility, will be assessed consistent with current 

practices and crosscutting guidances. 

These crosscutting recommendations will also be identified in each devicespecific performance criteria guidance as they are applicable. I would also 

like to emphasize again that only device-specific performance criteria 

guidances, in their final forum, can be implemented in the pathway. That 

means any devices within a device-specific guidance that is in draft form 

going through the public commenting period, cannot be used to submit a 
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09-24-20/12:00 pm ET 

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510(k) to the S&P pathway, but could still use the other available 510(k) 

pathways. 

The device-specific performance criteria guidances that are currently able to 

be used to submit a 510(k) to the S&P pathway, are for conventional Foley 

catheters and cutaneous electrodes for recording purposes. Next slide, please. 

As part of this pathway, FDA will identify appropriate test methods and 

performance criteria through guidance that will undergo a public commenting 

period before finalization. 

This will give an opportunity for stakeholders to provide input on the FDAidentified criteria and methods. FDA would ensure that the objective 

performance criteria represents performance that is at least equivalent to the 

performance of legally marketed devices. Importantly, if a legally marketed 

device performs at a certain level relative to its safety and effectiveness and a 

new device meets those same levels of performance for the same 

characteristics, then FDA could find that the new device is as safe and 

effective as the legally marketed device. 

Instead of reviewing data from direct comparison testing between the two 

devices, the FDA could support a finding of substantial equivalence based on 

data showing that the new device meets the level of performance of an 

appropriate predicate device. Next slide, please. 

Performance expectations described in a S&P device-specific guidance can 

come from a variety of sources. This can include FDA-recognized consensus 

standards, other FDA guidance, special controls, scientific literature and 

historical 510(k) submission data. In some cases these performance criteria 

may be described qualitatively such as some testing for biocompatibility. 

Additionally, performance criteria that are in FDA-recognized consensus 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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standards but do not identify explicitly in a device-specific safety and 

performance guidance should not be used for this pathway. 

FDA will ensure that the identified criteria are applicable to the device types 

explicitly described in the scope of each device-specific guidance. Next slide, 

please. Now I would like to walk through one of the device-specific 

performance criteria final guidances recently issued, to discuss how the 

information within should be used when submitting a 510(k) to the S&P 

pathway. In this example we will be looking at sections pulled directly from 

the conventional Foley catheter's performance criteria guidance. 

This will cover the characteristics of Foley catheters that are appropriate for 

the pathway, an example of a performance test with the relevant information 

that should be submitted to meet the performance criteria, and an example of a 

crosscutting recommendation that should be included as part of a submission 

to the pathway. Next slide, please. 

First, we will look at the scope and device description of Foley catheters 

appropriate for the S&P pathway. As you can see in the top paragraph, the 

appropriate device type is identified by the regulation number, in this case 21 

CFR 876.5130, and the product code, EZL. It is important to note that this 

particular guidance should only be used for devices with that particular 

regulation and product code. 

The second section outlines the intended use and indications for use of eligible 

Foley catheters. For instance, as part of this guidance, eligible devices would 

be those that are single use and have indwelling times of 30 days or less. This 

is based on FDA's assessment that the performance testing and criteria 

established in the guidance, adequately addresses the current level of 

performance of legally marketed devices. 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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Lastly, the bottom section outlines the design characteristics of Foley 

catheters that are eligible for the S&P pathway. In this case, the guidance 

described the range of French sizes and the maximum balloon volume of 

Foley catheters that should be evaluated. Additionally, this device-specific 

guidance will outline characteristics that FDA believes are outside the scope 

of submission to the pathway. 

For Foley catheters you can see this includes three lumen catheters, catheters 

with lubricious coatings, suprapubic catheters and antimicrobial catheters. 

Please note that this list of exclusionary characteristics may not be exhaustive 

but FDA will do its best to provide a comprehensive listing of what we 

believe to be appropriate. If you have questions about whether or not your 

device is appropriate for the pathway, then we would encourage you to reach 

out via a Q-Sub. Next slide, please. 

We will now look at an example performance test to be evaluated when 

submitting a 510(k) to the S&P pathway for Foley catheters. As a reminder, 

all performance criteria in a device-specific performance criteria guidance, 

should be met to submit a 510(k) to this pathway. This particular performance 

test assesses the Foley catheter flow rate as described in the FDA-recognized 

consensus standard, ASTM F623. 

Each performance test in all of the device-specific performance criteria 

guidances will follow a similar format to what is seen here. This includes the 

test name, the recommended test method, performance criteria, the source of 

the performance criteria and the type of information to be submitted to 

effectively show that the performance criteria were met. 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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Additionally, some performance tests may have additional considerations that 

FDA think are important to communicate to the manufacturer. Importantly, 

the amount and type of information that is provided for each test will be 

consistent with the policies outlined in table 1 of the safety and performancebased pathway programmatic guidance. In the case of this test, the 

submission information would consist of a declaration of conformity to 

ASTM F623. 

For additional information about declarations of conformity, I would 

encourage you to read FDA's guidance, Appropriate Use of Voluntary 

Consensus Standard and Pre-Market Submissions for Medical Devices which 

can also be found in the reference slide. Consistent with FDA policy, for all 

510(k) submissions, FDA may request and review underlying data 

demonstrating that a new device meets the FDA-identified performance 

criteria and testing methodology as necessary. Next slide, please. 

The last topic I'd like to discuss for this device-specific example, is a 

crosscutting recommendation that would be part of your 510(k) submission, in 

this case a biocompatibility evaluation. In this particular recommendation, we 

have outlined the biocompatibility endpoints that should be assessed specific 

to Foley catheters, described in the scope of this guidance. This is based on 

the categorized contact type and contact durations that are also described in 

this section. 

Importantly, these endpoints match that of Attachment A in the CDRH 

biocompatibility guidance. Any other applicable crosscutting 

recommendations, for instance, electrical safety or sterility, will be outlined in 

each device-specific performance criteria guidance and will be consistent with 

any FDA guidance on that specific topic. Next slide, please. 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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Now let's switch gears and discuss some of the nuances to submitting a 510(k) 

to the S&P pathway, the first of which is determining whether your device is 

appropriate for the pathway. As I mentioned previously, the scope of each 

device-specific performance criteria guidance will identify which device types 

are appropriate and that you should satisfy. You should also meet all of the 

performance criteria outlined in the device-specific guidance. 

Additionally, although it is not necessary to conduct side by side performance 

testing of a subject device to a predicate, it will still be necessary to identify 

an appropriate predicate for your submission, as you would in any other 

510(k) pathway. Next slide, please. 

I would now like to highlight a few key points - oh, I’m sorry. When 

submitting a device-specific guidance for the S&P pathway, new submissions 

will be evaluated through the same 510(k) substantial equivalence decision 

flowchart as before. However, this pathway is unique in that to demonstrate 

performance the subject device should meet all of the FDA-identified criteria 

in the device-specific guidance. 

Importantly, FDA believes these criteria are appropriate to determine 

substantial equivalence when the indications for use and technological 

characteristics do not raise different questions of safety and effectiveness from 

that of a predicate device. And that the criteria align with one or more 

predicates of the same device type. Next slide, please. 

Now I would like to highlight a few key points to consider when submitting a 

510(k) to the safety and performance-based pathway. Similar to the traditional 

and abbreviated pathways, the safety and performance-based pathway will 

have a MDUFA review clock of 90 days. Additionally, the MDUFA user fees 

will be the same as any other 510(k). When submitting a 510(k) submission 
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we are asking that manufacturers identify that their submission is intended for 

the S&P pathway in the submission cover letter. This will help FDA 

adequately process the submission in our system. Next slide, please. 

The Refuse to Accept process or RTA, will be consistent with the Refuse to 

Accept policy guidance and will be similar to that of the abbreviated 510(k) 

RTA checklist. Timeframes for the RTA and substantive interaction will also 

be the same. As with other 510(k) pathways, there will be an opportunity for 

a 510(k) submitted to the S&P pathway to be converted if there are issues that 

preclude review through this pathway. 

Ideally, determination of whether or not a 510(k) is appropriate for the 

pathway will be made during the RTA review stage at which point conversion 

to another pathway would be appropriate. If it is determined after the RTA 

review stage, that their submission does not meet the criteria or has 

insufficient information as outlined in a device-specific performance criteria 

guidance, then there will still be an opportunity for conversion to another 

pathway. However, the conversion of a submission to another viable 510(k) 

pathway may necessitate additional testing with a predicate comparison. Next 

slide, please. 

As with other pre-market submissions, the pre-submission or Q-Sub process is 

available if further clarification is needed to determine if your device is 

appropriate for the pathway. This can also be used to determine the 

appropriateness of test methods outside of those recommended by FDA, to 

meet the identified performance criteria. Additionally, a Q-Sub can be used to 

determine on a case-by-case basis, if additional testing you identify outside of 

the guidance, is necessary to demonstrate the safety and performance of the 

device. 
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For instance, if you wanted to add language to your labeling concerning 

magnetic resonance compatibility and there as not performance testing in the 

device-specific guidance for this feature, then additional performance testing 

would be necessary. Next slide, please.

As always, FDA encourages stakeholder interaction to facilitate the 

development of key policy initiatives. Particularly for the safety and 

performance based pathway, there are a number of ways stakeholders can 

contribute. This includes identifying device types that may be potential 

candidates for inclusion into the pathway; it could be identifying standardized 

criteria and scientific methods applicable to particular device types; it could 

also include ways to better harmonize with other regulatory jurisdictions. 

Again, we encourage all stakeholders to submit comments to the devicespecific performance criteria draft guidances during the public commenting 

period, as they are issued in the future. Additionally, the docket for the safety 

and performance programmatic guidance linked on the slide, will remain open 

to receive suggestions about the pathway and is monitored regularly. Next 

slide, please. 

And listed here are a number of links to items concerning the safety and 

performance-based pathway to be accessed once the slides are published on 

FDA's Web site. Next slide, please. And we can move onto the final slide. 

And with that, I would like to thank you for your time and we will now open 

the phone line for questions. 

Coordinator: Thank you. We will now begin the question and answer session. To ask a 

question from the phone lines please press star 1, ensure your phone is 

unmuted and record your name at the prompt. Your name is required to 
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Moderator: Irene Aihie

09-24-20/12:00 pm ET 

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introduce your question. To withdraw your question, press star 2. One 

moment please, for incoming questions. 

Jason Ryans: And so while we're preparing for the question and answer session, I'd like to 

address a couple of common questions that we've received recently, the first 

being can you propose device-specific topics to be added to the safety and 

performance device list? And the answer to that is yes. As I just mentioned 

recently, the safety and performance programmatic guidance docket is still 

open and recently people have submitted numerous topics that FDA is 

reviewing on a continual basis. 

Coordinator: Once again, as a reminder, to ask a question from the phone lines, please press 

star 1 and record your name at the prompt. At this time there are no questions 

from the phone lines. 

Irene Aihie: Thank you. Jason, would you want to have - do you have any closing remarks 

before we end the call? 

Jason Ryans: I think the main thing I would say is if you're looking for more information 

about the safety and performance-based pathway, we do have a FDA Web 

page dedicated particularly to this pathway, which you can find in the 

resource slides of this presentation. And it outlines all of the device-specific 

guidances that are in draft and final form currently. And we will be updating 

that Web page as more device specific guidances come forward. 

Irene Aihie: Thanks so much, Jason. Again, this is Irene Aihie. And we do appreciate 

your participation today. Today's presentation and transcript will be made 

available on the CDRH Learn Web page at 

www.FDA.gov/Training/CDRHLearn, by Friday, October 2. If you have 

additional questions about today's presentation please use the contact 
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09-24-20/12:00 pm ET 

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information provided at the end of the slide presentation. As always, we do 

appreciate your feedback. 

Following the conclusion of today's webinar, please complete a short 13 

question survey about your FDA CDRH webinar experience. The survey can 

be found at www.FDA.gov/CDRHWebinar, immediately following the 

conclusion of today's live webinar. Again, thank you for participating and this 

concludes today's webinar. 

Coordinator: Thank you all for your participation in today's conference. You may now 

disconnect. Speakers please hold for post-conference. 

END