FDA Webinar

Moderator: Irene Aihie

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FDA Webinar: Safety and Performance Based Pathway Performance Criteria

Moderator: Irene Aihie

November 7, 2019

1:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in a 

listen-only mode until the question and answer of today's conference. At that 

time to ask a question, press Star 1 on your phone and record your name at the 

prompt.

Today's call is being recorded. If you have any objections, you may 

disconnect at this time.

I would now like to turn the call over to Irene Aihie. Ma'am, you may begin.

Irene Aihie: Hello, and welcome to today's FDA webinar. I am Irene Aihie of CDRH's 

Office of Communication and Education. On September 19, 2019, the FDA 

issued four draft guidances and updated a final guidance related to the safety 

and performance-based pathway as part of our commitment to strengthening 

and modernizing the 510(k) program as described in the FDA's medical 

device safety action plan.

Today's webinar will provide details about the draft guidances and offer an 

opportunity for webinar participants to ask questions about the draft 
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guidances. Today Jason Ryans, technical guidance specialist in the Office of 

Product Evaluation and Quality here in CDRH will present an overview of the 

pathway including the updated final guidance and the draft guidance 

documents. 

Following the presentation we will open the line for your questions related to 

the information provided during the presentation. Additionally, there are other 

center subject matter experts here with us today to assist with the Q&A 

portion of our webinar. 

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 safety and performance-based pathway 

established in final guidance earlier this year as well as an introduction to the 

recently issued accompanying device-specific draft guidances.

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

presentation, some background information on the safety and performancebased pathway, an overview of the safety and performance-based pathway 

final guidance issued earlier this year, an introduction of the four draft devicespecific guidances issued this past September, some general information about 

510(k) submissions to the new pathway, a brief look at FDA's future plans for 

the pathway and potential opportunities for stakeholder engagement.

The objectives for this presentation are to walk through the policy of the 

safety and performance-based pathway as well as provide a brief overview of 

how the device-specific guidances will be utilized to submit a 510(k)

submission once they are finalized. 
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You may remember that in April 2018, the FDA released its medical device 

safety action plan. This described recent actions we've taken to enhance 

device safety and outlined our vision for how the agency can build on these 

initiatives to further ensure the safety and effectiveness of medical devices. In 

this plan, we committed to continue modernizing our approach to device 

safety. As part of our commitment in November 2018, former FDA 

Commissioner Dr. Scott Gottlieb and CDRH Director Dr. Jeff Shuren issued a 

joint statement announcing some of the steps the FDA is taking to modernize 

its 510(k) pathway.

The 510(k) program has undergone numerous changes since its inception 

through the medical device amendments of 1976. Over time, FDA has 

evolved the program as the statutory requirements progressed and the medical

device technological landscape advanced. These changes were implemented 

in an effort to ensure that the public would have timely access to safe and 

effective medical devices. 

Previously, the special and abbreviated 510(k) pathways were developed 

through guidance to create an efficient submission preparation and review 

process, while still promote FDA's mission to protect the public health. In 

particular the abbreviated pathway established a reliance on guidance 

documents, special controls and/or voluntary consensus standards to facilitate 

FDA's pre-market review of 510(k) submissions. While also -- without

altering the statutory requirements for substantial equivalence. It is this basis 

that the FDA leverages to establish the safety and performance-based 

pathway. 

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

pathway for demonstration of safety and effectiveness for certain wellunderstood devices. To facilitate a more modern paradigm, FDA intends to 
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expand the existing 510(k) program to allow manufacturers of certain wellunderstood device types to use objective performance criteria established or 

recognized by the agency to demonstrate substantial equivalence.

FDA will ensure that the objective criteria represent performance that is 

equivalent to modern technology. This approach will provide more direct 

evidence of the safety and performance of a device and better information for 

patients and providers to make well-informed healthcare decisions. 

Additionally, it will provide an opportunity for device developers to 

demonstrate that their product meets or exceeds these modern performance 

criteria as well as the ability to do so and in a more straightforward and 

streamlined manner.

The framework for this voluntary pathway was first outlined in draft guidance 

released in April 2018. Finalized in February of this year and then updated 

this past September. As mentioned previously the safety and performancebased pathway is optional and will not impede the use of other 510(k)

pathways including the traditional, special and abbreviated. 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.

Importantly, if a legally marketed device performs at certain levels relevant to 

its safety and effectiveness, and a new device meets those levels of 

performance for the same characteristics, FDA can find that the new device is 

as safe and effective as a legally marketed device. Instead of reviewing data 

from direct comparison testing between the two devices, FDA can support a 

finding a substantial equivalence based on data showing the new device meets 

the level of performance of an appropriate predicate device. 
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As a side note, device types that are eligible for third-party review in addition 

to being appropriate for the safety and performance-based pathway, will 

remain eligible for the 510(k) third-party review program. 

As part of this pathway, FDA will identify appropriate device types and 

performance criteria through guidance that will undergo a public comment 

period before finalization. This will give an opportunity for stakeholders to 

provide input on the FDA-identified criteria and methods. It is important to 

note that FDA will show that these criteria will represent performance levels 

that are at least equivalent to the performance of already legally marketed 

devices of the type to which they apply.

Performance expectations described in a safety and performance devicespecific guidance can come from a variety of sources. This includes FDArecognized 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 

standards but not identified explicitly in a safety and performance devicespecific guidance should not be used in 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. 

Once a device-specific guidance is finalized and the pathway can be 

implemented, 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 safety and performance 
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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.

Similar to other 510(k) pathways, an appropriate predicate should be 

identified for this pathway to determine that the new device's indications and 

technological characteristics do not raise new questions of safety and 

effectiveness. The subject device should be within the scope of the devicespecific guidance to ensure that the performance criteria appropriately align 

with the anticipated performance of the proposed device.

The amount and type of information necessary to support a finding of 

substantial equivalence under this pathway are summarized in the following 

table. And can also be found in Table 1 of the safety and performance-based 

pathway final guidance. To support an FDA finding of substantial equivalence 

through this pathway, FDA expects the submitter to demonstrate that the new 

devices meets the FDA identified criteria by submitting either a declaration of 

conformity to an FDA recognized consensus standard, a testing protocol, a 

result summary, and/or a complete test report as appropriate. 

For example, from the table provided, when a device-specific guidance 

identifies a performance test where the methodology comes from an FDArecognized consensus standard, and the criteria are FDA established for 

instance from analysis of historical 510(k) submissions, then the submitter can 

provide a declaration of conformity to the standard and a result summary for 

FDA to make a determination of substantial equivalence.
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Importantly, while a submitter may use an alternative to an FDA 

recommended test methodology accompanied with a complete test report, the 

FDA identified criteria should still be met. In some instances, submission 

information may deviate from this table slightly depending on the particular 

information that is used to satisfy the FDA identified criteria. Nevertheless, 

the device-specific guidances will outline what the expected submission 

information should be for each performance test. 

For the purposes of this pathway and to ensure that the performance criteria 

remains contemporary and take into account relevant data from recent 

clearances, FDA recommends that you provide a result summary for all tests 

evaluated in addition to other submission information, for example, a 

declaration of conformity, identified for each test or evaluation in the devicespecified guidance.

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. If data 

provided by the submitter do not show that the new device meets the 

performance criteria FDA has identified for the device type, then FDA would 

not be able to find that the new device is a substantially equivalent through

this pathway.

As previously mentioned, submitters could still use other available 510(k)

pathways to demonstrate substantial equivalence. For additional information

on the use of declarations of conformity and information regarding the 

submission of nonclinical bench testing information, please see the FDA 

guidance as referenced at the bottom of this slide. 
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In September of this year, FDA issued the first four device-specific draft 

guidances that outline the FDA-identified performance criteria and test 

methods for device types appropriate for the pathway once they are finalized. 

The device types include cutaneous electrodes for recording purposes, 

conventional Foley catheters, spinal plating systems, and orthopedic nonspinal metallic bone screws and washers. For each device-specific guidance, 

when possible FDA will prioritize the inclusion of performance criteria and 

methodologies from FDA-recognized consensus standards. Otherwise, FDA 

intends to leverage the knowledge, experience, and applicable data within the 

agency to establish appropriate criteria and methods.

As mentioned previously, some criteria may be qualitative and FDA will 

make an effort to not deviate from current practices, excuse me, to assess 

these evaluations. To identify which device types are appropriate for the 

pathway, FDA will include information and 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 and/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. 

For ease of accessibility, FDA will make available any and all device types 

and their accompanying device-specific guidances on the safety and 

performance-based pathway webpage. This website will also contain any 

supplemental information to assist in the submission of 510(k)s to the 

pathway. Once device-specific guidances are finalized, FDA intends to 

periodically review the appropriateness of device types for inclusion in the 
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pathway based on a number of factors. This may include an evolution in the 

scientific understanding of the safety and/or effectiveness of a device, or the 

emergence of a particular safety signals after marketing of the device. 

FDA reserves the right to add or remove device types appropriate for the 

pathway and may revise performance criteria or test methodologies over time 

as necessary. The decision to modify or remove a device type for the pathway 

will be based on the ability to support a determination of substantial 

equivalence, particularly if it is deemed that the current performance criteria 

are not adequate to fully address the safety and effectiveness of a device. 

Importantly, any changes made to the list of device types that can use the 

pathway would be applied prospectively to devices from which a 510(k) has 

not yet been submitted. Therefore a 510(k) that is cleared for a device type 

that is later removed from the pathway would still be considered a legally 

marketed device. However, any future submissions should be submitted 

through either the traditional, special or abbreviated pathway.

I would now like to highlight a few things to consider when submitting a 

510(k) to the safety and performance-based pathway once it is finalized. This 

is not an exhaustive list and may be subject to changes as we get closer to the 

finalization of the device-specific guidances. As with other premarket 

applications, the Pre-submission process is available if further clarification is 

needed to determine if your device is appropriate for the pathway as well as 

the appropriateness of test methods outside of those recommended by FDA.

Additionally, the Pre-submission 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. For instance, if you'd 
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like to add language to your labeling concerning magnetic resonance 

compatibility, then additional performance testing would be necessary.

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 RTA 

checklist. Similar to the traditional and abbreviated pathways, the safety and 

performance-based pathway will have an FDA review clock of 90 days and 

the timeframe for the RTA and substantive interaction will also be the same.

Moving forward, FDA’s next priority will be to fully implement the safety 

and performance-based pathway. Currently, the four device-specific draft 

guidances are open for public comment and we encourage all stakeholders to 

participate in providing feedback. Once the comment period has closed, we 

will review the comments and make any necessary changes to issue a finalized 

version. Additionally, FDA will continue to develop device-specific draft 

guidances for the pathway and anticipates continued issuance in the near 

future.

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, identifying standardized criteria and 

scientific methods applicable to appropriate device types, and ways to better 

harmonize with other regulatory jurisdictions.

Again, we encourage all stakeholders to submit comments to the individual 

dockets for the device-specific guidances which will be open until December 

19 of this year. Additionally, the docket for the safety and performance-based 
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pathway final guidance is and will remain open to receive general comments 

about the pathway. 

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

performance-based pathway that can be accessed once the slides are published 

on FDA's website. 

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

phone lines for questions.

Coordinator: Thank you. We'll now begin the question and answer session. If you would 

like to ask a question, please press Star 1 on your touchtone phone. Make 

sure your phone is unmuted and record your name clearly when prompted. 

Your name will be required to introduce your question. If you need to 

withdraw your question, you may press Star 2. Again, to ask a question, 

please press Star 1 and record your name. It will take a moment for questions

to come through. Please stand by.

Jason Ryans: While we're preparing for the question and answer session, I'd like to reiterate 

a couple of important points. One, the current draft device-specific guidances 

will be open for comment until December 19 and we highly encourage all 

stakeholder input. Second, the safety and performance-based pathway cannot 

be implemented until the current device-specific draft guidances are finalized 

which will occur sometime next year.

Coordinator: And I'm showing no questions in the queue at this time. But again if you 

would like to ask a question, please press Star 1 and record your name.

And we do have a question coming in. One moment. And our question comes 

from (Robert Phillips). Your line is now open.
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(Robert Phillips): Thank you and thank you for the presentation today. My question is, do you 

have any idea when we may see additional guidances for additional products? 

And if you don't have a list you're already working on, is there a way for 

industry to submit products that we would be interested to see safety and 

performance guidelines on?

Jason Ryans: Yes, so we are continually working on draft guidances for different product 

areas. And we will be issuing some draft - additional draft guidances in the 

near future. If you wish to submit some suggestions as I mentioned, the safety 

and performance final guidance docket is a place where you can submit any 

product areas as well as standardized criteria or potential methodology that we 

can evaluate.

(Robert Phillips): Very good, thank you.

Coordinator: And again, if you'd like to ask a question, please press Star 1 and record your 

name. Please stand by. I'm showing no further questions in the queue at this 

time. And so I will turn the call back over to Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today's presentation and transcript will be made 

available on the CDRH learn webpage at www.fda.gov/training/cdrhlearn by 

Friday, November 15. If you have additional questions about today's 

presentation, please use the contact information provided at the end of the 

slide presentation. 

As always, we appreciate your feedback. Following the conclusion of today's 

live webinar, please complete a short 13-questions survey about your FDA, 

CDRH webinar experience. This survey can be found at 
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www.fda.gov/cdrhwebinar immediately following the conclusion of today's 

live webinar. 

Again, thank you for participating. This concludes today's webinar.

Coordinator: That concludes today's conference. Thank you for participating. You may 

disconnect at this time.

END