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FDA Webinar: The Special 510(k) Program: Final Guidance

Moderator: Irene Aihie

October 31, 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 session of today's conference. 

At that time, you may press Star 1 on your phone to ask a question. I would 

like to inform all parties that today's conference is being recorded. If you have 

any objections, you may disconnect at this time. I will now turn the 

conference over to Irene Aihie. Thank you. 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 12, 2019, the FDA 

issued a final guidance document on the special 510(k) program. The new 

510(k) paradigm alternate approaches to demonstrating potential equivalent 

and premarket notification guidance is superseded by this final guidance 

document and the abbreviated 510(k) program which reflects the abbreviated 

510(k) information from the new 510(k) paradigm guidance.

This webinar will provide details about the final Special 510(k) Program 

Guidance and offer an opportunity for webinar participants to ask questions 

about the final guidance. Today, Angela DeMarco, 510(k) expert in the Office 

of Regulatory Programs and Joshua Silverstein, Regulatory Advisor in the 
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Office of Product Evaluation and Quality, both here in CDRH will present an 

overview of the final Special 510(k) Program Guidance document. Following 

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

information provided during this presentation.

Additionally, there are other (unintelligible) subject matter experts here with 

us today to assist with the Q&A portion of our webinar. 

Now, I give you Angela.

Joshua Silverstein: Good afternoon. Thank you for the introduction, Irene. Thank you all for 

joining today's webinar on the Special 510(k) Program. As Irene noted, my 

name is Josh Silverstein. I'm a Regulatory Advisor in the Office of Product 

Evaluation and Quality in the Regulation, Policy and Guidance Staff. I'll be 

presenting today with Angela DeMarco from the Office of Regulatory 

Programs, 510(k) Program. (Marjorie Shulman), Assistant Director of the 

Office of Regulatory Programs’s Division 1 that oversees the 510(k) program,

is also here to help answer questions.

The agenda for today's webinar is to explain the background on the Special

510(k) Program, the results from the Special 510(k) Program pilot, provide an 

overview of the special 510(k) Program including related guidance updates

and resources that are available. We will then have a question and answer 

session.

At the end of this training, you should be able to understand the results of the 

Special 510(k) Program Pilot, be able to determine whether your 510(k) is 

appropriate to be submitted within the Special 510(k) program and prepare 

your 510(k) and what to expect during this review and understand how FDA 

updated other guidance documents to reflect the updated Special 510(k)
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Program improve alignment between the related 510(k) guidance and current 

policies. You should also understand the resources available if you have any 

questions.

The Special 510(k) Program was first introduced by the guidance, “The New 

510(k) Paradigm Alternative Approaches To Demonstrating Substantial 

Equivalence In Pre-Market Notifications.” We informally call this guidance

the New 510(k) Paradigm. The New 510(k) Paradigm was issued on March 

20, 1998. At that time, design controls requirements were recently introduced

as part of the final rule of the Quality System Regulation under 21 CFR Part 

820. 

The Special 510(k) Program leverages design controls requirements and 

procedures along with previously submitted information that an FDA can do a 

summary level review for certain 510(k)s in 30 days. We would like to 

emphasize that the Special 510(k) Program does not alter any requirements 

related to 510(k) submissions or substantial equivalence including those under 

Section 510 and 513 of the Federal Food, Drug and Cosmetic Act and 21 CFR 

807 subpart E. 

In September of 2018, FDA issued draft guidance that proposed updates and 

clarifications to the prior Special 510(k) Program. CDRH also launched a 

pilot program to assess these factors. On September 13, 2019, FDA issued 

two separate final guidance that superseded the New 510(k) Paradigm with 

guidance. There's now the Special 510(k) Program and the Abbreviated 

510(k) Program guidance documents respectively.

FDA also withdraw the frequently asked questions on the New 510(k)

Paradigm guidance because we incorporated the information into the new 
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final guidance documents, or the information can be found in other FDA 

guidance.

Providing a new final guidance on the Special 510(k) Program is part of the 

Agency’s ongoing effort to improve the efficiency of 510(k) Review as the 

FDA works to simplify this process and help promote timely access to safe 

effective and high-quality medical devices. The Special 510(k) Program is an 

optional pathway that submitters may use when they would like to introduce 

well-defined modifications to their own device such that design control 

procedures produce reliable results that can help form in addition to other 

510(k) content requirements the basis of the substantial equivalent decision.

We would like to reiterate that 510(k) content requirements still apply to 

Special 510(k)s. 

So on October 1 of 2018, CDRH launched the Special 510(k) Program pilot to 

allow industry and FDA staff an opportunity to test an expansion of the 

Special 510(k) Program. All Special 510(k)s received on or after October 1, 

2018 that were marked as a special were considered as part of the pilot 

program to determine if they were appropriate for review as a Special 510(k). 

The pilot was initiated to determine whether updated eligibility factors would 

improve the efficiency of FDA's review of Special 510(k)s and expand the 

types of changes appropriate to be reviewed under this program.

So like I said already, all 510(k)s that CDRH received after October 1 of 2018 

that were identified at Special 510(k) were included in this pilot. On the next 

two slides, we will discuss the results and the analysis reflects data captured 

from October 1, 2018 until July 1, 2019.
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During the webinar for the Special 510(k) Program pilot, we stated that we 

would be collecting the following information to assess the pilot. The total 

number of Special 510(k)s received during the pilot if placed on hold, the 

FDA day on which it was placed on hold. And the total time to decision 

which includes both FDA and manufacturer days. If the file was found to be 

inappropriate to continue as a Special 510(k), we collected the reason for 

conversation, the day on which it was converted, and the conversation rate for 

the specified timeframe.

For those that do not know, FDA days are those calendar days when a 

submission is considered to be under review at the agency for 510(k)

submission that have been accepted. For 510(k)s, FDA days begin on the date 

of receipt of the submission that enables the submission to be accepted. More 

information on these terms can be found in the MDUFA IV commitment letter 

on FDA's website.

The results of our data analysis from the pilot are shown on this slide. As 

mentioned, we analyzed data from October 1, 2018 until July 1, 2019 and 

compared the data to that collected during the same period during the previous 

calendar year. With an increase in the total number of submissions, we saw 

decreases in both the average total time to decision and the overall conversion 

rate. We believe that this is due to the new factors expanding the types of 

changes appropriate for review under the Special 510(k).

This also speaks to the broad range of well-established methods that allow our 

review staff to efficiently review the proposed changes and associated 

performance data. When a 510(k) during the pilot was found to be 

inappropriate as a special, the reason it was found inappropriate was most 

often that the 510(k) lacked a well-established method to assess the change 
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followed by the inability to place the data into a summary or risk analysis 

format. 

Often a methodology that was either modified in such a manner that created 

the new method that had not been used before or the submitter had developed 

a new methodology in addition to using well-established methods. We would 

like to reiterate that all methods used within a special 510(k) should be well 

established to remain appropriate for review as a Special 510(k). Based on 

these results and comments received to the docket, we updated the final 

guidance to include more detail on what could be considered a wellestablished method. We also encourage submitters to consider presubmissions 

to discuss whether their proposed method is well-established if they're 

uncertain. 

During the pilot, FDA did not automatically convert for changes to the 

indications for use or IFU. This was a conversation reason in the old policy 

and accounted for 21% of conversions. The new Special 510(k) policy 

focuses on the methods that are used to evaluate changes and whether any 

performance data can be summarized.

Occasionally 510(k)s were converted for reasons outside of the eligibility 

factor stated in the guidance. These were most often for clerical errors. For 

example, if a file was marked as a Special 510(k) but the submitter stated it 

was a traditional or if the file was incorrectly marked upon receipt. An 

additional reason is with regard to recall issues associated with the subject 

device.

When FDA issues the draft guidance on September 28, 2018, we requested 

public comment on a proposed new Special 510(k) policy. Overall we 

received approximately 130 comments from 13 groups or individuals which 
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included medical device manufacturers, trade associations, patient advocacy 

groups and consulting firms. 

Based on comments received, we made minor changes to the guidance prior to 

issuing final guidance on September 13, 2019. There were three main areas 

that received the most comments; the eligibility factors, examples included in 

the guidance and clarification to the overall policy. Regarding the eligibility 

factors, we updated well-established methods to include those that are found 

in final FDA guidance documents and qualified medical device development 

tools or MDDTs.

The list in the final guidance is not all-inclusive. If you believe you have a 

method that is well-established, we encourage you to submit a presubmission 

to discuss the proposed method with the review team before submitting your 

510(k). We also clarified that if the change involves generally more than 

three scientific disciplines it would not be appropriate for review as a Special

510(k). Scientific disciplines include areas such as biocompatibility, software,

and electrical safety.

Most comments received on the examples were asking for more in-vitro 

diagnostic device or IVD examples. The final guidance includes several new 

IVD examples. We made minor updates to the other examples to clarify why 

a change was or was not found to be appropriate for a Special 510(k). General 

policy updates we made include a clarification that the final Special 510(k)

guidance does not supersede the recommendations in other guidance 

documents. For example, we refer (unintelligible) to the bundling policy for 

how unrelated changes affect eligibility and to the reprocessed single-use 

devices guidance document to determine whether the change is appropriate for 

Special 510(k).
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We also included more specificity of how to describe changes from the 

predicate device. For example, we encourage a tabular format with redlined

copies of modified documents. 

Now we will discuss differences between the new final guidance and the 

policy that it superseded. The Special 510(k) Program under the new 510(k)

paradigm focused on whether changes affect intended use or altered the 

fundamental scientific technology of the device. In an internal discussion, we 

found that most Special 510(k) conversions under the new paradigm occurred 

due to methods not being within the predicate's clearance. However, there are 

many methods out there, including those in FDA recognized consensus 

standards, that are well-established such that FDA does not need to review a 

complete test report and would still have sufficient information to establish 

substantial equivalence. 

FDA's updated eligibility factors in the final guidance focus on the methods 

used to evaluate changes that needed a 510(k). Because the program relies on 

existing design control processes and FDA's previous review of detailed 

information on the existing device, the Special 510(k) should still be 

submitted by the manufacturer authorized to market the existing device which 

in this context is also the predicate.

We'll now focus our assessment on whether any performance data is 

necessary, whether well-established methods exist to evaluate the change and 

if any data necessary to evaluate and support substantial equivalence can be 

reviewed in a summary or risk analysis format. We would like to reiterate 

that the FDA does not intend to automatically convert for changes to the 

indications for use.
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In developing new eligibility factors, we leveraged the existing Special 510(k)

Program and believed the factors in the final guidance will allow for more 

510(k)s to be reviewed as specials, which was reflected in the results of the 

pilot which show a decrease in the conversion rate. 

FDA has a flowchart in the final guidance that will be used to support 

decisions of whether a 510(k) can be appropriately reviewed as a Special 

510(k). For the purposes of that flowchart, we assume that the manufacturer 

has concluded that a 510(k) is required pursuant to 21 CFR 807.81(a)(3). 

Additionally, this flowchart is just a visual aid and should be used with the 

rest of the final guidance document to determine whether a 510(k) is 

appropriate to be reviewed as a special. The high level process for 

determining whether your 510(k) is appropriate for the special pathway is 

outlined on the slide. The following slides will include more detail.

Starting on the left, the first step is to ensure that the device you are modifying 

is your own. FDA intends to convert a 510(k), Special 510(k) that's submitted 

for a change to a device made by another manufacturer. Next if performance 

data are unnecessary to support the proposed change, then the change is 

appropriate to proceed through the Special 510(k) pathway. If the 

performance data are necessary, a well-established method should be to 

evaluate all aspects of the change. If either of these apply to your 510(k) then 

we move to the next factor.

All performance data provided with the submission should be able to be 

summarized, reviewed in a summary or risk analysis format. The summary 

should be detailed enough to support substantial equivalence. If you have met 

all the eligibility factors then your 510(k) is most like appropriate to proceed 

through the Special 510(k) pathway.
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I'd like to summarize the high level points again. Number 1 is that all Special 

510(k)s should be submitted by the manufacturer authorized to market the 

existing device. Two, when performance data are not necessary that 510(k)

could be reviewed as a Special 510(k). The performance data are necessary 

well-established methods should be available to evaluate the change. And last, 

the performance data should be able to be reviewed by FDS in a summary or 

risk analysis format without losing informant necessary to evaluate substantial 

equivalence.

We'll now go through each eligibility factor in a more detailed fashion. The 

first factor for determining appropriateness is whether the change is being 

made to the manufacturer's own device. This has not changed from the new 

510(k) paradigm. The predicate device to which the change is being made 

should be the manufacturer's own device. And this is because Special 510(k)

leverages the information that was already submitted to FDA and also relies 

on existing design control procedures developed by the manufacturer of both 

the predicate and the subject device.

Once it has been established that the device being modified is the predicate 

manufacturer's own device, we then determine whether performance data is 

needed to evaluate the change. We make this determination for changes to the 

indications for use, labeling and or technology changes.

We would like to emphasize that the FDA does not intend to automatically 

convert a 510(k) for changes to the indications for use. Under the final 

guidance we are assessing whether performance data is needed to evaluate the 

change before deciding to convert the submission. If performance data is 

deemed not necessary to evaluate the change, then the 510(k) is appropriate to 

continue as a special 510(k). If the performance data is deemed necessary then 

we proceed to the next eligibility factor.
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And now Angela will discuss the remaining eligibility factors and processes 

for the Special 510(k) Program in more detail.

Angela DeMarco Thanks, Josh. Once it has been determined that performance data are 

necessary to evaluate the change, we ask whether there is a well-established

method to evaluate that change. We consider well-established method to be 

those used in the previously cleared 510(k), methods in an FDA- recognized 

consensus standard or guidance document, qualified medical device 

development tools and methods published in the public domain that are 

widely available and accepted for those found acceptable in another premarket 

solution by the same manufacturer.

All methods identified in the subject 510(k) should be well-established. 

Otherwise the FDA intends to convert the submission to a traditional 510(k). 

If you are unsure about whether the method or methods you would like to use 

would be considered well-established, we encourage you to submit a presubmission to discuss the proposed method or methods with reviewing 

division. It is important to note that methods that rely on clinical or animal 

data are typically not appropriate for the Special 510(k) Program .

If it is determined that all methods used to evaluate the change are wellestablished all performance data should be able to be reviewed in a summary 

or risk analysis format. Complete test reports should not be submitted in a 

Special 510(k). If complete test reports are submitted, FDA intends to 

determine if the data can be summarized. If FDA believes the data can be 

summarized, we will reach out to you so that you can place your data into a 

summary or risk analysis format. If FDA does not receive a timely response, 

we intend to convert the submission to a traditional 510(k).
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If however, the data cannot be summarized because the substantial 

equivalence decision depends on review of the underlying data, such as 

images, raw graphs, or line item data, FDA intends to convert the Special 

510(k) to a traditional 510(k). Please note that small numbers of 

representative images are acceptable as part of a Special 510(k).

There are several general instances in which a Special 510(k) may not be 

appropriate. If a modification to the device involve generally greater than 

three scientific disciplines, such as biocompatibility, electromagnetic 

compatibility and software, that could complicate the review such that it 

cannot be reasonably completed within 30 days. If a submission is bundled 

and the changes being made are unrelated to each other, in instances when a 

complete test report is necessary to establish the financial equivalence such as 

clinical data, novel test method, when validation method should be provided, 

or when a chemical characterization for toxicological assessment is needed for 

biocompatibility. And when validation data is required for reprocessed, 

single-use devices and reusable devices identified in their respective Federal 

Register notices.

In Appendix A of the final guidance, we provide recommendations on the 

content and format for Special 510(k). We encourage you to provide a 

detailed description of the changes you are making to the predicate device and 

include tabular comparison of the changes and what is remaining the same 

between the modified device and the cleared predicate device. If you are 

making modifications to document this is labeling our methodology risk 

analysis, we recommend including redlined copy of those documents to 

facilitate the review of the changes.

In addition to using the webpage on how to prepare Special 510(k), we 

continue to request a tabular summary of design control activities and a 
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summary or table that lists all changes made to the subject device compared to 

the predicate that is your risk analysis. When constructing your risk analysis, 

we recommend including a summary of verification and validation activities. 

This includes a summary of testing method used including deviations, the 

acceptance criteria and results, and other specimen of how the results support 

the substantial equivalence. We also expect an indication for use form and a 

science statement of design control activity to be provided with every Special 

510(k). 

The final guidance contains several examples for different types of changes 

and whether they would be appropriate for a Special 510(k). We will discuss 

three examples from that guidance over the next few slides. The example on 

this slide is B5 from the final guidance. It provides a labeling change to the - it 

involves a labeling change to the environment of use for a transcutaneous 

electrical nerve stimulator from a professional healthcare facility only to both 

a professional healthcare facility and home use. The device is still intended to 

be used under the direction of supervision of a healthcare professional.

It was confirmed that the predicate device is manufactured by the submitter of 

the Special 510(k) and that performance data are needed to evaluate the 

change. Electrical safety and electromagnetic compatibility testing were 

determined to be needed in order to assess the home use of the device because 

there are different acceptance criteria for home use. Both of the scientific 

discipline have associated FDA recognized consensus standards that can be 

utilized which the submitter chose to use.

In addition, the submitter tested to the FDA recognized consensus entered for 

home use devices. The submitter provided the acceptance criteria as a result in 

a summary table. The table also included a justification for all the results that 

were outside the bounds of the stated acceptance range or different from the 
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predicate so the FDA review team could adequately review the results to 

assess whether the device was substantially equivalent.

The results for the testing conducted could be summarized because the 

determination of substantial equivalent did not depend on FDA's interpretation 

of the underlying data such as images, raw graphs or line item data. Therefore 

this change can be reviewed as a Special 510(k).

This example is D3 from the final guidance. It involves a modification to the 

general indication for delivering elimination and laser energy for photo 

coagulation to include specific clinical applications for treatment of 

retinopathy. It was confirmed that the predicate device was manufactured by 

the submitter of the Special 510(k). And that performance data are needed to 

evaluate the change. In order to assess this change, clinical testing is typically 

provided in order to support the stated indication for use because the new 

indication identifies specific disease conditions.

The clinical output of the original submission, general coagulation of blood 

vessels have now become treatment of retinopathy which include decreased 

vision impairment. The clinical endpoints and methodology have changed 

from the predicate submission. And there is no consensus standard or other 

well-established methods available to assess the endpoint. Therefore this 

change cannot be reviewed as a Special 510(k).

This example is B9 from the guidance. It involves a labeling change of a blade 

(unintelligible) dental implant from safety and MRI not evaluated to MR 

conditional. It was confirmed that the predicate device is manufactured by the 

submitter of the Special 510(k). And that performance data are needed to 

evaluate the change. When manufacturers seek MR conditional labeling for 

device that contains a metallic component, nonclinical performance testing to 
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support substantial equivalent should be provided. FDA has a final guidance 

document that discusses the recommendations for such testing.

Because there are FDA recognized voluntary consensus standards for MR 

compatibility testing of passive implants, it was determined that wellestablished methods exist to evaluate the proposed change. However, the 

substantial equivalence determination relies on the review and interpretation 

of underlying data including device-specific pass or fail criteria and results not 

address in the consensus standard. This prevents the data from being 

appropriately summarized for review. Therefore this change cannot be 

reviewed in the Special 510(k). This scenario is also referenced in Section 

III.E of the final Special 510(k) of anticipated common scenarios for which

data may be unable to be summarized.

Appendix C of the final guidance includes sample table of how to summarize 

design control activity. In those tables, we recommend that you include all 

device changes made to the predicate device and risks associated with each 

status change, the method or methods used to evaluate the stated changes, the 

acceptance criteria and any deviation made to either the method or the 

acceptance criteria with justification for those deviations. We ask for a 

justification to all deviation so that we can assess whether the method used 

can still be considered well-established.

We also recommend you include a summary of results that are descriptive 

enough to understand how results relate to the acceptance criteria and methods 

used. For example, for variable tests meaning tests that don't have a 

straightforward pass or fail criteria, you should include a description of the 

results such as the acceptance criteria to pass with 7 out of 10 samples. The 

test passed with 8 out of 10. 
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If you choose to leverage results from another study for test performed, for 

example in one of your previously cleared premarket submission, we ask that 

you include a justification for why that methodology and results can be 

leveraged for the subject device. 

The process for submitting your Special 510(k) under the new final guidance 

has not changed. You still should identify the submission of the Special 

510(k), submit a valid eCopy to the document control center and pay the user 

the associated with the 510(k). Please note that a hard copy duplicate of 

eCopy no longer is required for 510(k) submissions, but a paper copy of the 

cover letter is still necessary. Special 510(k)s are still subject to the RTA for 

refuse to accept policy and will be checked for administrative completeness. 

The eligibility factors as outlined in the final guidance document are on Page 

1 of the Special 510(k) RTA checklist. 

FDA still intends to process Special 510(k) within 30 days. We anticipate the 

review to be interactive meaning requests for additional information will be 

made through email. However, the option for a hold to request additional 

information still exists for complex issues. 

If the 510(k) is found to be inappropriate to continue via the Special 510(k)

pathway, FDA intends to convert it to a traditional 510(k). The process for 

converting the 510(k) remains the same as under the prior policy. The lead 

reviewer obtains (unintelligible) and then seeks 510(k) staff concurrence. If 

converted, the lead reviewer will notify the official contact and explain the 

reason for the conversion. If converted, this may delay the review process 

because FDA will likely request complete test reports.

In addition to splitting the new 510(k) paradigm guidance into this Special 

510(k) Program guidance and the abbreviated 510(k) guidance, we issued two 
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other related final guidance. The refuse to accept, or RTA guidance, was 

updated to reflect the new Special 510(k) policy, improve alignment between 

related 510(k) guidance and to reflect current policies such as those found in 

the final guidance content of premarket submissions from management of 

cybersecurity and medical devices and final guidance “Use Of International 

Standard Iso 10993-1 Biological Evaluation Of Medical Devices: Part 1 

Evaluation And Testing Within A Risk Management Process.”

We also updated the “Format For Traditional And Abbreviated Premarket 

Notifications” guidance to align with the order of the RTA checklist and 

include current guidance and website links. You may have noticed that 

Sections 10 and 11, device description and executive summary respectively 

have switched positions in the final guidance compared to the prior version. 

This was only done to align with the RTA checklist. The updates made to this 

guidance are not intended to reflect new policy. 

All four documents of the Special 510(k) Program, the Abbreviated 510(k), 

RTA and Format guidance were issued as final guidance on September 13, 

2019. Due to the need for FDA and industry to have time to operationalize 

changes made to the RTA guidance, there's a 60-day delayed implementation 

in effect for the RTA guidance. This means that if a 510(k) is received before 

or up to 60 days after the publication date, FDA may decide not to refuse to 

accept based on the criteria in the new final guidance.

The implementation date for RTA will be November 13, 2019. This holds 

true for Special 510(k) RTA decisions as well. FDA will determine whether a 

submission is appropriate to proceed as a Special 510(k) using the eligibility 

factors as described in the new final guidance but intends to use the prior RTA 

guidance document to determine whether a file is administratively complete 

and accepted for substantive review.
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Here are the links to all four final guidance documents should you have 

additional questions following this webinar.

Thank you for your attention. This concludes the presentation. We are now 

happy to take questions.

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

like to ask a question, please press Star 1. Unmute your phone and record your 

name. Your name is required to introduce your question. This does take a few 

moments for the question to come through. Please continue.

Angela DeMarco While we wait for the first question, we do have some frequently asked 

questions that we wanted to share. The first one is, is the Special 510(k)

limited to specific product codes? And the answer is assuming that the 

changes are appropriate to be reviewed as a Special 510(k), there is no 

restriction on product codes for the Special 510(k) Program. 

Joshua Silverstein: Another frequently asked question that we have tried to reiterate through 

this webinar is can I submit a Special 510(k) if I've changed the indications 

for use? Yes, but the submission should rely on well-established methods and 

any data that’s necessary should be able to be summarized in a risk analysis 

format.

Angela DeMarco: Operator, we'll take our first question.

Coordinator: Thank you. And it does come from (Meghan Parker). Your line is open.

(Meghan Parker): Hi, thank you for the presentation. I have a question on the change in the 

program regarding intended use and indications for use. As you mentioned 
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earlier, the guidance discusses the differences between the previous program 

in which Special 510(k)s that included modifications to indications for use or 

any labeling change that affected the device's intended use were routinely 

converted to traditional 510(k)s. And under this new program, FDA now no 

longer intends to focus on changes that affect indications for use in 

determining whether a 510(k) is appropriate as a Special 510(k).

Given that change in focus, under the new program, will FDA routinely 

convert Special 510(k)s that seek an OTC indication for a device previously 

cleared as a prescription to traditional? Or could a 510(k) or Special 510(k) be 

appropriate for a prescription to OTC switch if the submission otherwise 

meets the standards in the new guidance?

Angela DeMarco Thank you for the question. We do in general consider a change from 

prescription to over-the-counter to be a change to indication for use. However, 

we do not intend to automatically convert for that type of change. It would 

depend on the type of performance data need, if any, to make this change. 

And if the performance data could be handled in a - through a well-established 

method and placed into a summary or risk analysis format, then it could 

proceed as a Special 510(k). But it does depend on whether or not the 

performance data necessary to support it could be done through a wellestablished method.

(Meghan Parker): Okay, thank you.

Coordinator: The next question comes from (Steven Inglesi). Your line is open.

(Steven Inglesi): Yes, good afternoon and thank you for taking my call and thank you for the 

presentation. We are a consulting firm that offers small business regulatory 

and quality support. On the regulatory side, we are often doing letters to file 
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based on looking at the FDA guidance when to submit or change - do a 

submission for a change device. We're constantly doing letters to file because 

we find that, and the client finds that to be appropriate. At what point would 

you see a Special would have to be done to - for the agency to recognize all 

the minor changes a firm has made to their medical device?

Joshua Silverstein: So this guidance would apply once the manufacturer has already made an 

assessment that a 510(k) is required. 

(Steven Inglesi): Okay. And so - if not, then we'd just be continuing to do letters to file because 

we find that appropriate based on guidance. So I thank you for your thoughts 

on that.

Joshua Silverstein: Thank you.

Coordinator: The next question comes from (Chris). Your line is open.

(Chris): Yes, hi. I'm focusing on software in medical devices and software as medical 

devices. And I'm still trying to get my - wrap my head around the 

performance data and the requirements or the guidance around that. So if a 

software change entailed using new or modified test protocols and by that I 

mean new or modified from the original submission or the predicate device, 

would that fact alone mean that a Special 510(k) is inappropriate? Or not?

Angela DeMarco Thank you for the question. So if you're making modifications to the software 

test protocols, we do encourage you to submit redlined copies so that the FDA 

review team can see exactly what changes are being made to help them 

determine whether or not it could still be considered a well-established

method. If you do have concerns, you could submit a presubmission prior to 

the 510(k) to obtain feedback from the FDA review team.
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(Chris): Okay, thank you.

Coordinator: The next questions comes from (Cliff Frederick). Your line is open.

(Cliff Frederick): Thank you for the opportunity to ask this question to you. If the holder of the 

original 510(k) changes their device by adding a component where that 

component has a previously 510(k) cleared change or technique that is held by 

another company, can the safety and performance testing methods referenced 

in the other company's 510(k) would qualify as a well-established method? I 

mean the same test methods would apply to the Special 510(k) device.

Joshua Silverstein: It would depend. If that was an internal protocol that other manufacturer 

that information would be protected from disclosure by FDA. If it was a 

method that was well-established in the public domain whether it be FDArecognized standards, an MDDT or something that like, that would be 

appropriate. But in terms of sort of like tapping into someone else's 

confidential information that something that we're not permitted to do.

(Cliff Frederick): No, if they have a signed agreement between those two companies.

Joshua Silverstein: If there is a signed agreement, that might be through a master file or 

through something else, that's something would probably - you would 

probably want to discuss that specifically with the review division, but if you 

had authorization from that party then that sounds like (unintelligible) okay.

(Cliff Frederick): Right, so can that authorization be included in the administrative section as an 

appendix to the cover letter can be (unintelligible) submission?

Joshua Silverstein: Yes.
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(Cliff Frederick): Okay, thank you so much for answering my question.

Coordinator: The next question comes from (Marisa). Your line is open.

(Marisa): Hello. So earlier the first presenter, the gentleman mentioned that not all of 

the 510(k) contents apply to the Special 510(k) content. And I was wondering 

if you could provide a list of which ones are not applicable?

Joshua Silverstein: I'm sorry if I misspoke. What I meant to say was that all content 

requirements do apply to a Special 510(k). I'll just refer you to Appendix A of 

the guidance of the final guidance document and that's your roadmap for the 

recommended content of a Special 510(k).

(Marisa): I guess are 510(k) summaries and truthful and accuracy statements also 

applicable for a Special 510(k) like they would be a 510(k) because I didn't 

see that explicitly called out in that appendix.

Joshua Silverstein: Yes.

(Marisa): Okay great, thank you so much.

Joshua Silverstein: Thank you. 

Coordinator: The next question comes from (Jean Asquith). Your line is open.

(Jean Asquith): Hi, yes. I'm calling in order to - I need to know if to submit a Special 510(k)

both design verification and validation as well as process validation has to be 

completed before actually submitting the 510(k).
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Angela DeMarco Yes, we do expect that all performance testing be completed prior to the 

submission of the 510(k).

(Jean Asquith): Okay, thank you.

Coordinator: And as a reminder, it is Star 1 if you would like to ask a question. The next 

question comes from (David Chadwick). Your line is open.

(David Chadwick): Yes, I wanted to ask. I just don't recall if a 510(k) filed under the S&P 

program is eligible for special or not. And if not, why not?

Angela DeMarco So once we have eligible devices under the safety and performance pathway, 

nothing would explicitly prohibit it from being a special 510(k) unless it does 

not meet the eligibility factors as stated in the guidance.

(David Chadwick): Okay, so under S&P though it would follow all established accepted 

methods, wouldn't it? Sorry for the follow-on?

Joshua Silverstein: Sorry, could you repeat that?

(David Chadwick): Under an S&P guidance that FDA issues wouldn't that include use of 

established methodology? So it wouldn't be a reason for rejection or 

conversion? And it should be applicable to a special if it's your own device.

Angela DeMarco Yes, as long as it does meet those well-established criteria and is able to be 

appropriately summarized or placed into a risk analysis format such that 

substantial equivalence could be determined from that summary format, then 

yes it could be appropriate for a Special 510(k).

(David Chadwick): Okay, thank you.
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Coordinator: And the next question comes from (Alyssa). Your line is open.

(Alyssa): Yes, hello, hi. Thank you for the presentation. I wanted to ask - you 

mentioned that there were three - you mentioned, I guess, biocompatibility 

and sterilization let's say. Because I have, let's say I have a submission that I 

have those two changes and of course their established methods. The question 

is, is that sufficient for a Special 510(k)?

Angela DeMarco Do you mean that if you were only to submit the biocompatibility and 

sterilization?

(Alyssa): Yes, I mean those are the two main changes that - for this specific device.

Coordinator: And are you ready for the next question?

Angela DeMarco One second (unintelligible).

Coordinator: Okay, thank you.

Angela DeMarco Answer the previous question. 

((Crosstalk))

(Alyssa): Did you understand my question?

Angela DeMarco Yes, we do understand it now. If it is under the three different scientific 

disciplines it is mostly likely appropriate for the Special 510(k) program. If it 

was more than ...
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(Alyssa): So what you're saying is if it was only two let's say ...

Angela DeMarco (Unintelligible). I’m sorry. Go ahead.

(Alyssa): Yes, I’m sorry. I didn't understand. You said if it's under three, so if I said it's 

only biocompatibility and sterilization, so that's - would that be eligible for a 

Special 510(k)?

Joshua Silverstein: Provided that you're able to - that Number 1, they're well-established 

methods to evaluate the change. And that the data can be summarized, yes.

(Alyssa): Okay.

Angela DeMarco We'll take our next question.

(Alyssa): Okay, thanks.

Coordinator: Okay, thank you. That comes from (Suder). Your line is open.

(Suder): Hi, so my question has to do with the three scientific disciplines as well. I was 

just curious if cybersecurity would qualify as a discipline? And as a follow-up 

I also wondered if there's additional thoughts that you have shared on the topic 

of cybersecurity beyond that example that's mentioned for wireless testing.

Joshua Silverstein: In general, we consider cybersecurity to be under the umbrella of 

software. In terms of additional thoughts on cybersecurity, unfortunately 

that's outside of the scope of today's webinar.

(Suder): Thank you.
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Coordinator: The next question comes from (Caperon). Your line is open.

(Caperon): Good afternoon. I was wondering if there's a list of what the FDA considers 

scientific disciplines that they're going to decide if what the threshold is.

Angela DeMarco We currently don't have a special list of what we consider to be separate 

scientific disciplines, but if you do have any concerns, we do recommend 

reaching out to the review team.

(Caperon): Thank you.

Joshua Silverstein: If any 510(k) were submitted or excuse me were converted for this reason, 

we would explain what those disciplines are in the conversion notification.

Coordinator: The next question comes from (Miya). Your line is open.

(Miya): Hey, thank you. My question was also related to a scientific discipline. One of 

my questions there are a few more. Is a human factor that you would consider 

as a scientific discipline?

Angela DeMarco Yes, we would consider human factors to be a scientific discipline because it 

does have its own set of testing.

(Miya): Okay and I just saw a slide. I was - I’m not sure what was on it, but it was 

about when it's not appropriate and it was stated something was human factor 

and (unintelligible). I have a project that does exactly that because our change 

is related to usability user needs. And so we, what we have to do is do a new 

(unintelligible) because we're talking about a small diameter with the same 

method as before, but we have to revalidate it anyway. And we have to do a 
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revalidation of the handling due to this change. And I would like to know if 

it's still appropriate for a Special 510(k) if we have to do this.

Joshua Silverstein: So you have a very device-specific question and we do recommend 

reaching out to the reviewing division. But just to kind of take a step back, 

there are situations where human factors validation data may not be able to be 

reviewed in a Special 510(k), but that doesn't mean that a human factors 

evaluation cannot be reviewed in a Special 510(k). Oftentimes, that just 

relates to how much information is going to be necessary to establish 

substantial equivalence.

(Miya): Okay, so it's not necessary just because there is a change and that requires 

human factor thing does not require. Okay, that's all I want to know. Thank 

you.

Joshua Silverstein: Thank you.

Coordinator: Thank you, and as a reminder, please limit your questions to one question in 

order to allow everyone to ask their questions today. Up next is (Jeffrey Wan). 

Your line is open.

(Jeffrey Wan): Hi and thank you for the presentation. I have a question regarding the 

submission of reusable devices that are reprocessed. I understand that all 

reprocessing data needs to be provided as complete test reports as per the 

federal register notice. However, in the situation where there is a proposed 

change that could affect the reprocessing, but the company intends to leverage 

results from a previous submission and not provide any additional 

reprocessing data, would this change still disqualify from Special 510(k)

eligibility?
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Joshua Silverstein: So if you were able to explain why no new validation data would be 

required in the 510(k), then it would be eligible for Special and we do have 

that on Page 14 of the guidance. I mean I'd refer you to that bullet. It's the last 

sentence.

Coordinator: Thank you, and the next question comes from (Chris). Your line is open.

(Chris): Yes, hi. Actually this is a follow-up question to my previous question about 

software in which you indicated that new or modified software test protocols 

should be submitted in a redlined version for the FDA to evaluate. The 

question, the follow-up question that I have is should the detailed test results 

also be included in the Special 510(k) submission.

Angela DeMarco So in a special 510(k) we do anticipate that all results would be in a summary 

or risk analysis format rather than the complete test results if you do feel the 

need to submit your complete test results, the Special 510(k) may not be 

appropriate. But this is something that you can discuss with the review team 

as to whether or not your results could be appropriately summarized.

Coordinator: Thank you. And the next question comes from (Melissa Summerfield). Your 

line is open.

(Melissa Summerfield): Yes, so my question has to do with timing for Special 510(k)s. 

With the 30 days being the target for review for a Special 510(k), when 

additional information is requested, does the clock stop until the information 

is received? And with the goal to still stay within 30 days?

Angela DeMarco Yes, one the file is placed on hold, you receive a hold letter. The FDA clock is 

paused until we receive your response. And FDA does still intend to complete 

the review within a total of 30 FDA days.
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(Melissa Summerfield): So if that hasn’t happened, should we contact the reviewer?

Angela DeMarco You can reach out to the review team. You can also reach out to the 510(k)

program staff in case the time does go well over the 30 days. You can reach 

out to us with any questions about that.

(Melissa Summerfield): Thank you very much.

Coordinator: Up next is (Robert Molinaro). Your line is open.

(Robert Molinaro): Hello. The presentation said that a Special 510(k) is not appropriate if 

validation data should be provided. I wanted to know when is it necessary to 

provide validation data.

Joshua Silverstein: So there are circumstances where it is a requirement and so for example 

we have two Federal Register notices that one of the previous questions 

related to on reusable devices and also reprocessed single-use devices. 

Coordinator: And you're ready for the next question?

Joshua Silverstein: Yes, please.

Coordinator: Thank you. That comes from (Repala). Your line is open.

(Repala): Hi, everyone. Good presentation, FDA. So my question is regarding a device 

which has two components. One is a catheter and one is electrical 

(unintelligible). So the change in the device would be two have the same 

catheter but replace the user interface which is an electrical complement to the 

(unintelligible) complement which is already cleared and manufactured by the 
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same company. So the testing would be doing majorly to have the 

compatibility between these two complements. So my question is that this 

change qualifies for a Special 510(k) and the second is that if we - if it 

qualifies and we have a predicate device, which one to be the primary 

predicate or can we use more than one predicate to justify? Because they are 

two complements part of the device.

Angela DeMarco So to generalize the issue, because it is somewhat device-specific, we 

typically expect that the device being modified serves as the primary predicate 

to the subject device within the Special 510(k). If you do have concerns about 

which device would be your predicate device, we do recommend you reach 

out in the presubmission to discuss how you would format your submission in 

terms of identifying the predicate device and how to explain the modifications 

made if you do have questions about that.

Coordinator: The next question comes from (Jackie Burinski). Your line is open.

(Jackie Burinski): I have a question regarding the conversion rate and the specific criteria for 

conversion from a Special to a traditional. So among the 25% in the pilot 

period that were converted, 59% were converted for well-established methods. 

Could you provide any additional information around what some of those 

well-established methods (unintelligible) during that pilot period?

Angela DeMarco Specifically if it was converted for lack of a well-established method, 

oftentimes it could have been novel clinical data that was provided, novel 

animal data as we have stated in the guidance. Those are typically not 

appropriate for a Special 510(k). There are other instances in which 

modifications to a well-established method were made such that it would no 

longer be considered to be a well-established method. If you do intend on 

modifying a consistent standard for example in order to fit your specific 
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device and are unsure whether or not it could still be considered a wellestablished method, we do recommend reaching out to the review team to 

discuss the changes to see whether or not it could still be considered a wellestablished method.

Coordinator: Thank you. And the next question comes from (Purnell). (Purnell), your line 

is open. Your line is open (Purnell). Would you like me to move on?

Angela DeMarco Yes, please.

Coordinator: The next question comes from (Mary). Your line is open. Hello, (Mary) your 

line is open. 

Angela DeMarco We'll take the next question.

Coordinator: Thank you and that comes from (Azita). Your line is open.

(Azita): Yes, hello. You mentioned that the changes can be submitted in a risk analysis 

format. Is there any specific format that the FDA has in mind or you can 

point us to?

Joshua Silverstein: Absolutely, we have example formats in Appendix C of the guidance 

document.

Coordinator: The next question comes from (Jean Asquith). Your line is open.

(Jean Asquith): Hi, I was just wondering. Does the FDA require all actions related to user 

validation be completed prior to submitting a Special 510(k) or can the 

Special 510(k) be submitted once all bench verification is completed and 

substantially equivalence is established knowing the design controls will 
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require all user and process validations as required will be completed prior to 

launch?

Angela DeMarco The FDA does expect all validation and performance data be completed prior 

to submitted the 510(k) so that we can make an appropriate determination to 

substantial equivalence.

Coordinator: The next question comes from (Chrissy Jakemar). Your line is open. 

(Chrissy Jakemar), your line is open.

(Shrudi): Is that for (Shrudi)?

Coordinator: Go ahead, your line is open.

(Shrudi): Hi, can you hear?

Coordinator: Yes, go ahead.

(Shrudi): Hi, what options are there for manufacturers when they disagree with the 

conversion?

Angela DeMarco If you disagree with the conversion as stated in the notification that the lead 

reviewer will send you, you can reach out to the lead reviewer and request 

further clarification. If you do have additional questions, please feel free to 

reach out to the 510(k) program staff and we would be happy to discuss the 

policy issue with you to ensure that both sides understand the policy and the 

conversion.

Coordinator: The next question comes from (Jackie Ban). Your line is open.
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(Jackie Ban): Hey, sorry I have a question about the timelines. I know you mentioned it's 

going to be 30 days even if the file is put on hold. I know with traditional 

510(k)s, there's the 60 days before the (SI) deadline and then it can be placed 

on hold. Is there an (SI) deadline for the Special 510(k), say at Day 15? Or it's 

just whenever FDA chooses to put the file on hold, they can, and then the 

clock resumes?

Joshua Silverstein: I'm sorry.

Angela DeMarco I'm sorry. For Special 510(k) we don't have an official (SI) date. We do 

encourage that lead reviewers if they do need to put it on hold, put it on hold 

approximately 20 days into the FDA review cycle. But there is no official (SI) 

date.

Coordinator: The next question comes from (Joan Berdstrum). Your line is open. (Joan 

Berdstrum), your line is open for your question.

(Joan Berdstrum): Hello, thank you. Can you hear me now?

Joshua Silverstein: Yes.

Coordinator: Yes, go ahead.

(John Berdstrum): Perfect. Thank you for the detailed webinar. I appreciate the information. My 

question is around indications for use. Can you direct me to resources to be 

able to identify whether an indication for use would be considered under this 

Special 510(k)?

Joshua Silverstein: So what we're trying to get both industry and our staff away from is even 

the discussion of indications for use in the context of whether a 510(k) is 
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appropriate. You would just typically - you would go through the flowchart 

and the accompanying text in the guidance document. And not think about 

indications for use in terms of whether your 510(k) is appropriate to be 

reviewed as a Special.

Coordinator: And as a reminder, it is Star 1 if you would like to ask a question. Please limit 

your questions to just one in order to allow everyone to ask their questions. 

And I do have the next question coming from (Purnell). Your line is open.

(Purnell): All right, thank you. Let's try this again. My name is (Purnell) and I have a 

question regarding the summary formats part of the decision tree and one of 

the examples or a couple of the examples in the guidance was talking about 

the manufacturer being able to provide the data in a summary format. Yet it 

was deemed not appropriate for a Special 510(k) because the FDA needed to 

review the underlying data to establish (unintelligible) equivalent decision. 

So my question is, I was wondering if the FDA is intending to provide 

additional guidelines as to situations where the FDA needed to review such 

underlying data or whether data can be summarized in acceptable summary 

format.

Joshua Silverstein: We do give two or three different examples throughout the guidance 

document. And so one of them includes the review of images. And so for 

certain data images might be captures using benchtop performance testing. 

And a few representative images and we're talking more in the radiology 

space are typically provided along with a board-certified radiologist. But if 

FDA believes that it needs to review a full dataset of images for a 510(k), we 

don’t think it would be appropriate for review.

Another example are graphs and so this might come up in certain testing 

methodologies for magnetic resonance compatibility. And do if the FDA 
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believes that we needed to review those graphs to establish substantial 

equivalence, that's another circumstance where data cannot be summarized.

Coordinator: The next question comes from (Don Peters). Your line is open.

(Don Peters): Hi, this is in regard to some of the questions with regard to multiple software 

changes and letter to files. If a Special 510(k) is needed, your suggestion is to 

bring redlines especially to change protocols. I was wondering if you could 

comment on how to best address that for incremental changes versus changes 

in aggregate. Thank you.

Angela DeMarco If you do make changes to the software protocol or methodology, we do ask 

that if applicable, use the redlined copy when you submit to the FDA. If it is a 

broader change to the software structure and you're uncertain whether or not 

this change could be appropriate for a special, we do recommend that you

reach out to the review team to determine the extent of the change and 

whether or not it would be appropriate for a Special 510(k).

Coordinator: Thank you. And the next question comes from (Alyssa).

(Alyssa): Yes, hello again. My question is I have a 510(k) that I'm planning to submit. 

And actually it's based on two 510(k)s. Again, these two 510(k)s were for 

legal devices that were cleared by the same manufacturer. I just wanted to 

know if I can submit this submission as a special based on those two 510(k)s.

Joshua Silverstein: Provided that you are able to get through the flowchart with one predicate. 

It sounds like it would be okay. But it would definitely depend on the 

individual circumstances of the submission.

Coordinator: And the next question comes from (Elaine).
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(Elaine): Hi, my question is, is it considered intended use if some (unintelligible) are 

removed from (unintelligible)?

Joshua Silverstein: I'm sorry. Could you please repeat the question?

(Elaine): Yes, my question is, is it considered intended use if some warnings 

(unintelligible) are removed?

Joshua Silverstein: So if warnings are removed from the instructions for use?

(Elaine): Right.

Joshua Silverstein: Yes, I mean so I think that's outside the scope of the guidance that we're 

talking about today. That relates more to our modifications policy. Did you 

have a question about how it relates to appropriateness in the Special 510(k)

Program?

(Elaine): No, thank you.

Joshua Silverstein: Okay.

Coordinator: And there are no other questions at this time. I'll turn it back to Irene Aihie. 

Thank you.

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

thoughtful questions. Today's presentation and transcript will remain 

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

Friday, November 8. If you have additional questions about today's 
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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-question survey about your FDA 

CDRH webinar experience. This survey can be found 

www.fda.gov/cdhrwebinar immediately following the conclusion of today's 

live webinar.

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

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

disconnect at this time. Speakers allow a moment of silence and stand by for 

your post-conference.

END