NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 1

FDA Webinar: Final Guidances on "Deciding When to Submit a 510(k) for a Change to an 

Existing Device” and “Deciding When to Submit a 510(k) for a Software 

Change to an Existing Device

 Moderator: Irene Aihie

 November 16, 2017

 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 to ask a question press Star 1 on your phone and record your 

name at the prompt.

This 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 October 25, 2017 the FDA released two final guidance documents: 

Deciding When to Submit a 510(k) for a Change to an Existing Device, which

defines the medical device changes broadly, and Deciding When to Submit a 

510(k) for a Software Change to an Existing Device, which focuses on 

software specific changes and complements the broader guidance documents.

Today Rebecca Nipper, Acting Associate Director for Regulations and 

Guidance, and Linda Ricci, Associate Director for Digital Health, both in the
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 2

Office of Device Evaluation here in CDRH, will present an overview of the 

final guidances.

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

information provided during the presentation. Additionally, there are other 

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

our webinar.

Now I give you Rebecca.

Rebecca Nipper: Thank you and good afternoon, or I guess morning for those of you on the 

West Coast. And thank you for joining us for the industry webinar on two 

recently published final guidance documents regarding when to submit a 

510(k) for a change to an existing device. My name is Rebecca Nipper, and 

with Linda Ricci I’ll be giving an overview of both guidance documents.

We’ll start by going over some background on 510(k) device modifications 

generally, including the regulatory basis for our decision making. We’ll then 

describe how these guidances were developed, and our goals for the policy in 

these final guidances. We’ll walk through the highlights of each guidance, 

and there should be adequate time at the end for questions and answers.

At a time when medical technology is rapidly evolving, we wanted to develop 

guidance that provides essential flexibility to industry and FDA regarding 

when submission is required for device modifications instead of rigidly 

defining the types of changes that require FDA review. We think this will 

enable innovation and ensure agency oversight only when necessary. This 

strategy is also intended to ensure patients and providers have timely access to 

modified devices.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 3

There are two primary regulations that form the basis for our modifications 

policy: 21 CFR 807.81(a)(3) which describes when a new 510(k) is required 

due to a change or modification to a device, and 21 CFR 820 which is the 

quality system regulation.

I won’t read the entire text of 807.81(a)(3), but emphasis has been added to 

two of the most important elements of the regulation that describe what 

constitutes a significant change or modification that requires a new 510(k)

submission. Specifically, FDA requires a new 510(k) submission when the 

modifications could significantly affect the safety or effectiveness of the 

device or the change is a major change or modification in the intended use of 

the device.

Due to the subjectivity of “significantly” and “major,” these phrases 

sometimes lead to different interpretations, and these guidance documents 

seek to clarify our interpretation of these key terms. 

In developing this guidance we also carefully considered the role that the 

quality system regulation 21 CFR Part 820 plays in changes to devices. For 

some types of changes to a device we believe that submission of a new 510(k)

is not required, and that reliance on existing quality system requirements is the 

least burdensome approach to regulation of the change.

Regardless of whether a change requires submission or review, the quality 

system regulation requires manufacturers of finished medical devices to 

review and approve changes to device design and production, and document 

changes and approvals in the device master records. 

As specifically shown here, 820.30(i) outlines the manufacturer’s obligations 

regarding design changes. We want to emphasize that whether or not a new 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 4

510(k) is necessary, robust documentation of device modifications is helpful 

to both FDA and manufacturers.

During both the initial drafting and the finalization of these guidances, 

stakeholder feedback was actively sought in order to focus the revised 

guidances, not just on changes that FDA felt were important, but also on 

updates that other stakeholders would find valuable. Avenues for feedback 

included the draft guidances as well as the 2013 public meeting.

In the feedback we received, what we consistently heard was that there was a 

consensus around retaining the basic structure and paradigm in the original 

“Deciding When to Submit” guidance often referred to as the K97 guidance. 

There was agreement that clarification was needed in certain targeted areas, 

and that FDA should explore greater reliance on risk management and the 

quality system regulation where appropriate.

Based on that feedback, we made some targeted changes in comparison to the 

original K97 guidance. Most importantly we wanted to provide added clarity 

overall, but specifically around the interpretation of the key regulatory terms 

such as “could significantly affect.” We updated the flow charts and made 

sure that they aligned with the text so that they could serve as a companion to 

but not a substitute for the text within each section.

We updated the key principles underlying the decision paradigm, made some 

updated changes regarding the underlying decision – oops – made some 

updated changes regarding the materials section and added a large number of 

illustrative examples. We also added an appendix with documentation 

recommendations and examples in order to demonstrate how the complexity 

of documentation could vary depending on the complexity of the device 

change.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 5

We also decided to create a separate software guidance based on the same key 

principles, and added a risk assessment paradigm to the decision-making

process for all changes. 

While Linda will go into the details of the software modifications guidance, I 

wanted to outline the scope of each guidance and highlight areas of alignment. 

Both guidances apply to legally marketed devices subject to 510(k)

requirements, which means that PMA devices and 510(k) exempt devices are 

outside the scope.

While the general guidance does not apply to software systems changes, it 

does apply to non-software changes to software devices or devices containing 

software. For example, labeling changes would be assessed under the general 

guidance. You will also see that the guiding principles are consistent between 

the two guidances.

The software guidance does not apply to software for which FDA has stated in 

guidance that we do not intend to enforce compliance with applicable 

regulatory control. The software guidance also does not address other 

software related concepts like the software life cycle, what documentation 

should be included in a 510(k) for a software modification, or the principles 

that are applied to the validation of medical device software.

We want to highlight that when there are multiple changes that affect the 

labeling or hardware in addition to software, the changes should be assessed 

using both guidances. And if either guidance leads to a new 510(k)

conclusion, then submission of a new 510(k) is likely required.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 6

For example, if you wanted to add a new mode to a software only device, you 

would assess the change under the software modifications guidance. You 

would only need to use the general modifications guidance if there was also 

labeling revisions or changes to the indications for use are warranted based on 

the new mode. Similarly, if a new mode were added to an infusion pump, you 

would use the software modifications guidance for the software revisions, and 

then the general modifications guidance for the change to the pump 

specifications.

Both guidances have ten guiding principles that are the essential principles 

necessary for use of the documents. Previously in K97 these were referred to 

as assumptions and axioms. These principles are intended to be used in 

conjunction with the more specific guidance sections.

Note that the order in which I present these may not be consistent with the 

guidance. But the first guiding principle relates to modifications made with 

the intent to significantly affect the safety or effectiveness of the device, as the 

regulation states that a change that could significantly affect safety or 

effectiveness requires a new 510(k).

It is therefore the first principle that if there’s a change that is intended to 

significantly affect the safety or effectiveness of a device, for example to 

address an adverse event, that change would likely require a new 510(k)

submission. However, changes not intended to significantly affect safety or 

effectiveness should be evaluated using the rest of the guidance.

The next guiding principle relates to the assessment of “could significantly 

affect” and the role of testing. An initial risk based assessment should be 

conducted using the concepts in this guidance to make an initial determination 

of whether a new 510(k) is necessary. If the initial decision following the risk 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 7

based assessment is that submission of a new 510(k) is not required, this 

decision should be confirmed by successful routine verification and validation 

activities.

If routine verification and validation activities produce any unexpected results, 

any prior decisions that submission of a new 510(k) is not required should be 

reconsidered. This concept is discussed further in Sections B and D of the 

guidance. If the result of a risk based assessment is that a change could 

significantly affect safety or effectiveness, submission of a new 510(k) is 

required even if routine verification and validation activities are conducted 

successfully without any unexpected results.

The next guiding principle addresses unintended consequences of changes. 

The concept of this is that after you consider whether the change was made 

with the intent to significantly affect safety or effectiveness, you should also 

consider whether the change could have unintended consequences. 

For example, changes in sterilization may unintentionally affect device 

materials, or changes to materials may unintentionally affect the performance 

of the device. Any unintended consequences such as these should be 

evaluated according to the relevant flow charts and their companion text to 

determine whether submission of a 510(k) is required. 

The next guiding principle relates to the use of risk management, which plays

a central role in determining when a change could significantly affect safety or 

effectiveness as previously mentioned. This assessment is intended to 

leverage a manufacturer’s existing risk processes to determine when a change 

requires a 510(k). A risk based assessment is referred to throughout the 

document – as referred to throughout the document is based on the 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 8

combination of multiple risk concepts that are important for managing the 

risks of medical devices.

The concept of risk as defined in the FDA recognized consensus standard 

ISO14971 is the combination of the probability of occurrence of harm and the 

severity of that harm. Although the risk terminology used in this document is 

primarily derived from ISO14971, we recognize that an individual

manufacturer’s terminology may differ, but the concepts remain the same.

Because the regulation requires submission of a new 510(k) when a change 

could significantly affect safety or effectiveness, both safety and effectiveness 

should be considered in evaluating a device’s risk profile, and performing a 

risk based assessment as explained in Section E.

The next principle addresses the evaluation of simultaneous changes and 

simply states that when there are multiple changes, they should be assessed 

both separately and together. Next the guiding principles describe an 

appropriate comparative device and the cumulative effect of changes.

When determining whether a particular change requires submission of a new 

510(k), you should conduct a risk based assessment that compares the 

changed device to the device as previously found to be substantially 

equivalent in your most recently cleared 510(k). The appropriate comparative 

device is referred to as the original device throughout the guidance document.

In some cases you may make a number of changes without having to submit a 

new 510(k). But each time you make a change the modified device should be 

compared to the original device. When the cumulative effect of individual 

changes triggers the regulatory threshold for submission, you should submit a 

new 510(k).
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 9

The next guiding principle relates to the documentation requirements. 

Whenever you make a change to a device, you must comply with the quality 

system regulation which requires among other things that device changes be 

documented. The scope and type of documentation may vary, but the process 

of documenting the decisions described in this guidance should be established 

as part of your own quality system.

The next guiding principle describes what should be included in 510(k)

submissions for modified devices. When a new 510(k) is submitted for a 

device with multiple changes, that 510(k) should describe all changes that 

trigger the requirement for submission of a new 510(k). 

To help ensure that FDA has a complete understanding of the device under 

review, that 510(k) should also describe other changes since the most recently 

cleared 510(k). In other words, those that did not require submission of a new 

510(k) that would have been documented as part of the first 510(k) for that 

device.

For instance, 510(k)s typically include a listing of device warnings on the 

labeling. So if a warning in the device’s labeling has been changed, that 

change should be described in the new 510(k), even if that change itself did 

not trigger the requirement for submission of a new 510(k). However, a 

510(k) would not typically identify or describe individual components of a 

circuit board, such as resistors. And therefore we would not expect changes to 

the resistors to be listed in the new 510(k) for a modified device because the 

original 510(k) would not have included information about the resistors.

If you make multiple changes to a device but only one change triggers the 

requirement for submission of a new 510(k), the changes that do not require 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 10

submission of the new 510(k) may be immediately implemented, so long as 

those changes can be implemented independently of changes that do require 

submission of a new 510(k). Those changes should however also be 

described in the new 510(k) for the change that does require submission.

The last guiding principle is a reminder that even though you may correctly 

follow this guidance and submit a new 510(k) when necessary, a substantially 

equivalent determination is not assured.

These guidances use flow charts and text to guide you through the logic 

scheme we recommend to arrive at a decision on whether to submit a new 

510(k) for a change to an existing device. A single logic scheme containing 

all the necessary steps would be large and difficult to navigate. Therefore, for 

ease of use, the single scheme has been broken down into smaller sections 

with corresponding text and flow charts. As a reminder, the flow charts are 

intended as a visual aid, and do not capture all necessary considerations.

All labeling changes should be evaluated using the logic scheme in Section A 

that concentrates on changes in indications for use, and applies a risk based 

assessment framework for determining whether submission of a new 510(k) is 

required. This section focuses on changes to the indications for use and 

changes to other places – pieces of the labeling that could affect the 

indications for use.

Rather than assessing the intended use of the device specifically, since a new 

intended use would indicate that the device was no longer within the 510(k)

paradigm, like the K97 guidance, this guidance refers to the changes that have 

a major impact on the intended use of the device including certain indications 

for use changes.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 11

Whether the change is to the indications for use statement or to other parts of 

the labeling that affect indications for use, the guidance first describes 

common indications for use changes that likely do or do not require new 

510(k)s, such as a change from single use to reusable or a change from 

prescription to over the counter.

It then walks through indications changes that depend on a variety of factors 

and recommends the factors that should be considered. Factors that could 

affect the indications for use include but are not limited to patient population, 

use environment, or frequency and duration. 

For example, for a change in use environment you should consider whether 

the device user changes, like the training of the user or whether the 

environment presents different challenges such as lower levels of cleanliness 

or different sources of electrical interference. Either to assist in this type of 

assessment or for labeling changes that do not affect the indications for use, a 

risk based assessment should be conducted to identify any new or 

significantly modified existing risks in order to determine if a new 510(k) is 

likely required. 

Section B relates to technology, engineering and performance changes. These 

types of changes encompass a broad span of device activities, from minor 

engineering changes to a circuit board layout to a change from 

electromechanical to microprocessor control of device function. 

These changes should be evaluated using the scheme, and then the changes 

should be verified and/or validated according to the quality system 

requirements. This section begins with recommendations on a few specific 

changes such as fundamental device changes that almost always require a new 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 12

510(k) submission, or sterility in packaging changes which should be further 

assessed with some targeted questions.

It then assesses all other technology changes through a series of questions 

relating to if the change significantly affects the use of the device, if a risk 

based assessment identifies any new or significantly modified existing risks, if 

clinical data is necessary, and finally, if there are any unexpected results from 

the verification and validation activities.

As I mentioned in the guiding principles, all changes to device design should 

undergo some level of design verification and/or validation or evaluation to 

ensure that the device continues to perform as intended. You should make an 

initial risk based assessment of whether a change requires submission of a 

new 510(k). And if after an initial assessment that submission of a new 

510(k) is not required, you should conduct routine verification and validation 

activities to ensure that no new issues of safety or effectiveness are raised.

If successful verification and validation activities confirm the initial 

assessment, you should proceed with the design change and document the 

assessment. Occasionally routine verification and validation activities may 

either produce unexpected results or otherwise prove to be inadequate to 

verify and/or validate the modified design. In such instances a new 510(k) is 

likely required.

Similar to the concepts in K97, if you encounter unexpected results 

performing routine verification and validation activities, for example the 

device does not perform as expected, prespecified acceptance criteria are not 

met or testing demonstrates unexpected safety or effectiveness issues, the 

initial risk based assessment should be reevaluated.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 13

If different verification and/or validation test methods or acceptance criteria 

are necessary to produce the expected results, it is likely that the change could

significantly affect safety or effectiveness, and thus submission of a new 

510(k) is likely required. 

Section C of the guidance is specific to materials changes. It focuses on a risk 

assessment of material changes using similar biocompatibility risk assessment 

principles as described in FDA’s biocompatibility guidance. It begins by 

assessing if the new material has any new or increased biocompatibility 

concerns compared to the unmodified material, and if so, if the same material 

has been used by the same manufacturer previously in a similar device.

If so, you may be able to determine that the new material could not 

significantly affect safety or effectiveness. If not, a new 510(k) is likely 

required. If there are no new or increased biocompatibility concerns or the 

material doesn’t have direct or indirect patient contact, you should also assess 

if the change could affect device performance. If so, you would evaluate the 

change also as a technology change.

Section D focuses on changes in technology, engineering performance or 

materials of an IVD. Modifications to IVDs other than to the labeling are 

assessed using this IVD specific section, while the guiding principles, labeling 

and risk assessment sections of this guidance continue to apply to IVDs.

Changes assessed using this scheme can include changes made to reagents or 

changes to a test method or protocol among other things. For IVDs 

performance generally refers to the analytical and clinical specifications 

established as part of the most recent 510(k) clearance.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 14

The analysis is similar to that found in the non-IVD technology and materials 

sections, but is tailored to use language relevant to IVDs in explaining how 

decisions should be made for IVDs. Like the other sections, it focuses on a 

risk based assessment and changes that can affect IVD performance.

Section E describes considerations for performing risk based assessments of 

modified devices. As discussed throughout the document, a device 

modification that leads to a significant change in the device’s risk profile 

likely requires submission of a new 510(k). You should use the risk based 

assessment considerations discussed in this section in conjunction with the 

logic schemes and decision-making flow charts in the previous sections.

Although FDA recommends that manufacturers use an accepted method of 

risk assessment such as ISO14971, this guidance uses terminology distinct 

from ISO14971. 

In general, the assessment of risk in deciding whether to submit a new 510(k)

should identify all possible risks associated with the change or modified 

device, and then focus on risks whose existence and characteristics are 

supported by objective scientific evidence. It is generally not necessary to 

focus on hypothetical risks that are not supported by scientific evidence or 

those that are determined to be negligible, due to both the low probability of 

occurrence and low severity of harm. You should then explore the severity 

and probability of occurrence of the harm to determine whether the device 

change could significantly affect safety or effectiveness and requires 

submission of a new 510(k).

Although ISO14971 defines risk in terms of device harms and their effects on 

safety, it is important to note that whether submission of a new 510(k) is 

required depends on whether the change could significantly affect the safety 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 15

or effectiveness of the device. Therefore you should also consider the 

possible affects a device change may have on device effectiveness.

As with safety risks, you should consider the probability and severity of 

impacts to device effectiveness. In considering a device change’s effects, you 

should also consider the criticality of the device feature being modified to the 

safe and effective use of the device. Then certain features are more critical 

than others.

For instance, the outer case of a ventilator, although important to the overall 

design of the device, is not as critical to the safe and effective use of the 

device as the pump that circulates air to the patient. Note that labeling 

changes which affect user actions can be critical as well.

Appendix A gives over 30 hypothetical examples that are intended to illustrate 

the process of determining when a 510(k) is required. We include examples 

of results both in the need to submit and the need only for documentation to 

the file, and also include multi-part iterative examples to demonstrate how 

different factors can have an impact on the decision outcome.

For example, each example follows a similar format, walking through the 

relevant questions with explanations for the response of each step, and why or 

why not the ultimate decision would be to submit or not submit a 510(k). It is 

important to note that these examples cannot account for every possible 

scenario, and are not intended to be definitive.

I won’t walk through this entire example, but you can see the format where 

we describe the change, and then assess each relevant question using the 

applicable logic scheme, finally arriving at the likely decision.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 16

Whenever you change a device you must take certain actions to comply with 

the quality system regulations unless a regulatory exemption exists. The 

quality system regulation requires that design changes in production and 

process changes be documented prior to implementation. If you determine 

that the device changes do not require submission of a new 510(k), you should 

document the decision-making process and the basis for that conclusion.

The documentation should be prepared in a way that an FDA inspector or 

other third party can understand what the change is and the rationale 

underlying your conclusion that submission of a new 510(k) is not required. 

We want to note that only highlighting the flow chart in this guidance 

document or simply answering yes or not to each question without further 

details or justification is not sufficient documentation.

Appendix D provides recommendations on the basic elements of good 

documentation that every manufacturer should use. It also provides examples 

of documentation that can be adapted to the complexity of a given change.

I’ll now turn it over to Linda who will walk through the software guidance.

Linda Ricci: Hello. Now we’re going to switch to discussing the guidance ”Deciding when 

to submit a 510(k) for a software change to an existing device”. 

The software modifications guidance as I will call it for short, has the same 

general principles as the general guidance that Rebecca just discussed. In this 

section of the presentation, we’re going to talk about the software specific 

policy which is made up of four questions plus some additional 

considerations. This guidance also contains software specific examples in the 

appendix.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 17

Shown here is the flow chart from the guidance that describes the policy for 

how to determine if you need to make a submission for a change to a software 

device. We’re going to walk through each question in specifics.

So for Question number one, it asks “Is the change made solely to strengthen 

cyber security and does not have any other impact on the software or the 

device”. It is important to remember that cyber security is a continuing issue

for the center. We expect all devices to be able to be updated in the field, and 

therefore they would need to continue to update their cyber security aspects.

A majority of these changes for cyber security are referred to as patching. 

These are routine cyber security updates, and as we have said in many 

guidance documents related to cyber security, routine patching often does not 

require a 510(k). So when answering this question, if there are no other 

changes to the software or the architecture that are included in this change for 

cyber security and the change does not have any impact on the device, it is 

likely that a new submission would not be required. If you answer no to this 

question, then you would continue to the next question.

Question 2 is does the change – ”Is the change made solely to return the 

system into the specification of the most recently cleared device”. This 

question is addressing changes that might be made to the software that were 

originally specified for the original device. To answer yes to this question, it

is important to remember that the specification is for the most recently cleared 

device. 

It is also important to remember that the change should not have an overall 

impact on the device that could significantly affect safety, effectiveness or 

intended use. If you answer yes to this question, then you would document 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 18

the change that has been described previously along with the rationale. If you 

answer no, then you would continue to Question 3. 

Question 3 is really a two-part question and presents the biggest change from 

the structure of the document as compared to the draft. In this question we 

talk about all risk aspects for determining if the change would significantly 

impact. So in Question 3A we are discussing – or the question asks ”Does the 

change introduce a new risk or modify an existing risk that could result in 

significant harm and that is not effectively mitigated in the most recently 

cleared device”.

In this criteria for assessing, if you – how to answer this question, you want to 

consider if the change creates a new or modifies an existing hazard, hazardous 

situation, or cause in the risk management files. The level of harm associated 

within your modified hazard, hazardous situation or cause is serious or more 

severe, and if the hazard and hazardous situation or cause is not already 

effectively mitigated in the most recently clear device. If all the criteria are 

met, then a new 510(k) is likely required. If the answer is no to this, then you 

continue to Question B – 3B. 

Question 3B discusses risk control measures that are necessary. So the 

question is specifically “Does the change create or necessitate a new risk 

control measure or a modification of an existing risk control measure for a 

hazardous situation that could result in significant harm”. In this particular 

question you need to determine whether there are changes or additions of risk 

control measures that are necessary due to either new, modified or previously 

unknown hazardous situations or causes, and if the change to the risk controls 

are necessary to prevent significant harm.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 19

A submission is also not likely required when implementing redundant risk 

control. So if you determine that the hazardous situation is adequately 

mitigated and you’re adding redundant risk control, then it’s not likely that 

you would need a 510(k) just to add that additional risk control. If the answer 

to this question is no, then you would continue to Question 4.

Question 4 discusses the effectiveness aspect of could change significantly

impact. So in this question if the change could significantly affect clinical 

functionality or performance specifications that are directly associated with 

the intended use of the device. This question is addressing whether there are

additional or changes to clinical functionality or performance specifications.

Now these changes would need to be directly associated with the intended 

use. We understand that often there can be changes that could fall under the 

clinical functionality or performance specification label, but do not directly 

impact the intended use or are not directly associated with the intended use. 

For these specific changes we are looking at those that are directly associated 

with the intended use.

If the answer to this question is yes, then a new 510(k) is likely required. If 

the answer is no, then we ask you to go to the additional factors to consider if 

any of those apply in making your determination if the new 510(k) is required.

Software often can be changed in a number of ways for maintenance or just 

general infrastructure changes. We wanted to identify these various changes 

that could happen to software throughout its life cycle and talk about them as 

the additional factors in this guidance. So we list a number of them including 

changes such as changes to the infrastructure, changes to the overall 

architecture, or changes to the core algorithm.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 20

Additionally we talk about clarification of requirements where there is no 

change to the functionality of the software or cosmetic changes. Now 

clarification to the requirement would be changes that are to the 

documentation itself and not necessarily to the software itself. Oftentimes this 

is done for readability or to provide better maintenance. Cosmetic changes 

where there are no changes to the functionality again would not likely impact 

the clinical use of the device.

And lastly under additional factors we discuss reengineering or refactoring. 

These are software maintenance techniques and basically are looking at how 

you can redo the software or reengineer the software in different ways. 

Reengineering is talking about the examination or alteration of software to 

reconstitute it in a new form, whereas refactoring is a discipline technique for 

restructuring a software’s internal structure.

As I mentioned earlier, the software guidance also has its own set of 

examples. The examples focus on each of the questions asked and provides 

the rationale for the question at hand. So in this example the question at hand 

is Question 3A. We provided scenarios through the description, the question 

that we’re answering, the answer for the question and the rationale for that 

answer and finely the outcome.

Now I would like to turn it over 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, please press Star 2.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 21

Again to ask a question press Star 1 and record your name. It will take a 

moment for questions to come through. Please stand by.

Rebecca Nipper: As we get ready to answer questions from the phone, I wanted to note that we 

have had a few questions since the guidance was published regarding what we 

refer to as a CBE 510(k) or a “changes being effected.” This exact language 

was also included in the K97 guidance, so the concept should not be new.

The concept is similar to the special 510(k) corrective action being affected 

found in the K95-1 recall guidance, although the two should not be confused. 

As we state in the modifications guidance, it’s a special 510(k) submission 

used only to add a contraindication, and it can be implemented prior to 

clearance of the special 510(k). 

Irene Aihie: Operator, we’ll take our first question.

Coordinator: Thank you. The first question comes from (Alco Mall). Your line is open.

Irene Aihie: (Alco), we are unable to hear you on conference. Could you please check 

your mute button?

(Alco Mall): Oh yes, I think I made a mistake. I don’t have a question.

Coordinator: Very good. Our next question comes from (Mark McCarty). Your line is 

open.

(Mark McCarty): Hi. Thank you very much for taking the question. This question is in 

connection with cosmetic changes under the software 510(k) changes 

guidance that was just discussed by Ms. Ricci. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 22

You know one of the things that occur to me in that context was a change to, a 

cosmetic change, you know, might be construed as one that changes the 

appearance of a device where there might be human factors engineering 

considerations. Are you able to kind of fill in a little bit where cosmetic

change would not – would and would not seem to affect the usability of a

device and hence, you know, maybe or maybe does not require any kind of 

human factors and thus triggers a new 510(k)?

Sorry if I stumbled there. Hopefully the gist of the question got across to you.

Linda Ricci: Sure. No, I understand your question. So certainly there could be a number 

of cosmetic changes that would not necessarily require usability testing or any 

kind of human factors testing. They could be things as simple as changing the 

flash screen for your device or changing the logo for your company name. I 

mean those are two things that come to mind immediately that are definitely

cosmetic changes that are unlikely to require a new 510(k).

I would like to say that when determining whether or not you would need to 

do human factors testing for other changes to a user interface, you should be 

following your own internal procedures through your design controls that 

determine when you would need to do that kind of testing. It’s also not 

necessarily – excuse me. You’re not necessarily going to need to submit a 

new 510(k) just because you had to redo your human factors testing to 

demonstrate that your usability has not changed due to a change in the user 

interface.

So I would really – when you’re looking at cosmetic changes, for the software 

guidance this is really talking about changes to perhaps the screen layout that 

are not indicative of strong changes to the usability. You know if you are 

making strong changes to the usability, then I would definitely look at how 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 23

that could impact your risk mitigation perhaps rather than considering it just a 

cosmetic change.

(Mark McCarty): Okay.

Linda Ricci: Does that make sense?

(Mark McCarty): Yes, absolutely. Thank you very much. I appreciate it.

Coordinator: And for participants, we are taking questions through the phone lines only. So 

if you’d like to ask a question, please press Star 1 and record your name.

The next question comes from (Laura Crosky). Your line is open.

(Laura Crosky): Hi. Thank you for taking the question. I had a question for Rebecca 

regarding the general guidance. When the general guidance makes reference 

to a risk assessment being performed in accordance with 14971, I wanted to 

understand what the expectation of the FDA is around that.

Would completion of a hazard analysis be sufficient? Or is a design risk 

assessment required and a process risk assessment required even if the 

proposed change isn’t impacting either of those two categories?

Rebecca Nipper: So I think we purposely chose terminology in the guidance of a risk based 

assessment. And it may be different than your formal risk assessment that 

you’re used to doing, you know, for your internal processes. I think really

what we’re looking for, if you read through the guidances, is an assessment of 

any new risks or significant changes to known risks, and how those play into 

the decision-making process for whether a new 510(k) is needed.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 24

So it may be a little different than your formal 14971 risk analysis. That may 

be a document that can feed into your decision analysis, but it is a little bit 

different.

(Laura Crosky): Okay, thank you.

Coordinator: Our next question comes from (Bethany Hudson). Your line is open.

(Bethany Hudson): Hello. I have a question in regard to the indications for use change. In the 

event that the indications are staying exactly the same but it’s changing to a 

different part of the body, would that still be considered a new 510(k) if the 

device itself isn’t really performing any – it doesn’t have any functionality in 

relation to addressing the disease. It’s only a plug. 

So it’s just moving to another part of the body, and the indications are the 

same. Would that still be required to be submitted under a 510(k)?

Rebecca Nipper: So I think you should look at Sections or Questions A4 and A5 in the 

guidance. That specifically talks to changes in patient population as well as 

changes in area of the body. I think it’s under A5 where we specifically talk 

about a change in body part or area to of device – area of the body that the 

device is applied to.

And so I think that could be part of a risk based assessment. And you would 

determine whether or not a new 510(k) is necessary based on your risk based 

assessment. I don’t think there’s any one size fits all answer to moving from 

one part of the body to another.

(Bethany Hudson): Okay, great. Thank you very much.
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 25

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

(Jennifer Marsh): Hi, yes. I was curious to know what the expectation is from FDA on the 

implementation timeline for this.

Rebecca Nipper: So I think the guidance – there’s no delayed implementation. I think our 

expectation is that sponsors are already making these decisions, and the 

paradigm hasn’t really shifted. And so I don’t really think there’s any delayed 

implementation of the guidance. I think it should kind of be what companies 

are doing already.

Irene Aihie: And we’ll take our next question. 

Coordinator: Next question comes from (David Thomas). Your line is open. 

(David Thomas): Yes, hi. Thanks for taking my question. My question is around a material 

change, and if you change say from a lead contacting material from say a 

polyethylene material from one supplier to another, and you determine you 

still do biocompatibility testing on that material because you would for a new 

material but that biocompatibility testing doesn’t show any new concerns 

based on the risks. Would that then necessarily lead to a new 510(k) for that 

type of change? 

Rebecca Nipper: It really depends on the specifics around the change and if you’ve used that 

other – that material previously in a similar type of device. We do address 

supplier changes in the guidance and how that could play into a risk-based 

assessment, so I would encourage you to look specifically in section C and 

follow that thought process to see whether or not in your specific case that 

would require a new 510(k) or not. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 26

You know, as we note, that you can’t necessarily test out of a new 

510(k)510(k), so if the change could significantly affect the safety or 

effectiveness you would need a new submission. Whether or not testing 

demonstrates that there is not a change in safety or effectiveness. 

(David Thomas): Okay, so if I understand correctly, then even if the testing demonstrates 

there’s no issues with the new material from safety and effectiveness, that 

would still likely lead to a 510(k)510(k)? 

Rebecca Nipper: Again it just really depends on the specifics of the change and of the polymer 

and where you’ve used it previously, so I would encourage you to walk 

through the questions in the flow chart to see exactly where you would come 

out in your specific instance. 

(David Thomas): Okay, thank you. 

Coordinator: Our next question comes from (Gwen Payne), your line is open. 

(Gwen Payne): Hello, I was wondering if there is a section of the guidance that defines 

effectiveness or how the FDA defines that, and a significant impact to 

effectiveness. 

Rebecca Nipper: I think because we regulate a wide range of devices, that effectiveness is 

different depending on the product, and so I think the entire guidance kind of 

speaks to what could be – what could constitute a significant change -- that’s 

kind of the intent of the entire context of the guidance is how to define 

significant in the context of your device and the thought process you would 

follow to come to that conclusion. 

Irene Aihie: We’ll take our next question. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 27

Coordinator: The next question comes from (Betsy Sour), your line is open. 

(Betsy Sour): Hello, thanks for taking the question. Thanks for all the work you put into 

these guidance documents and I think it’s a really nice framework to work 

with. 

I am having a little bit of a hard time squaring in the general guidance the text 

for question A3 about a change in warnings and precautions with some of the 

guiding principles, so the description about changes in warnings and 

precautions encourages the manufacturer to monitor device usage, make 

prompt revisions based on user experiences, and that one of the things that 

could prompt a new warning might be an adverse event that had been reported 

through the MDR process. 

And then it immediately goes on to say submission of new 510(k)510(k) for 

such labeling changes are not generally required. And that seems to be a little 

bit at odds with the fact that that might also come with an intent to change 

safety and effectiveness based on field information so I would really 

appreciate to hear a little of your thinking about how those two things align 

with each other. 

Rebecca Nipper: I think we’ll need to get back to you on that question. Can you please send 

that question through our 510(k)510(k) staff or through DICE, and we will be 

able to answer that more thoroughly. 

(Betsy Sour): Certainly, thank you. 

Coordinator: Next question comes from (Alison Chan). Your line is open. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 28

(Alison Chan): Hi, my question is more on the general guidance. If a modification was made 

to reduce risk and successful routine verification and validation activity 

confirmed that reduction in risk, would that still require a 510(k)? 

Rebecca Nipper: I think it depends on the significance of the change, so the regulation says if it 

significantly affects safety or effectiveness, and so if you are looking to – if 

your intent is to reduce risk and significantly affect the safety or effectiveness 

of the device, then the new 510(k) is likely required. Otherwise you would 

need to work through whichever flow charts apply for your specific change 

and see if the risk-based assessment results in the need for a new 510(k) or 

not. 

(Alison Chan): Thank you. 

Coordinator: And our next question comes from (Carrie Plummer). Your line is open. 

(Carrie Plummer): Hi, thanks, yes, I have a question related to safety and effectiveness. What if 

an organization initially determines that safety and effectiveness through the 

risk assessment process will not be affected and that verification and 

validation then shows the device continues to meet the originally defined 

specifications, but a significant improvement is observed in the performance 

of the device? Is a 510(k) needed in this case? 

Rebecca Nipper: Because the regulatory threshold is whether or not the change significantly 

affects safety or effectiveness that change can be either for the positive or the 

negative, and therefore if you have determined that there is a significant 

impact on safety or effectiveness, then a new 510(k) is likely required. 

(Carrie Plummer): Okay, and then a follow-up question, it’s the same one that another caller had 

in FDA’s position on what significant equivalents means. I am not able to find 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 29

clear direction or guidance within these documents on FDA’s position on that 

or how to determine it. 

Linda Ricci: So again we understand that the original language in K97 when we talked 

about significant change was not necessarily as clear as everyone would like, 

and these guidances were really intended to provide more clarity with regards 

to what significant impact means. Now we understand that every 

manufacturer and every device has different risk level perhaps and certainly 

different effectiveness level. 

So while it might seem challenging that we don’t provide a concrete example 

of significant with regards to you know, a specific number or percent change 

or something like that, we really wanted manufacturers to have the flexibility 

to use this guidance along with their own processes to make that 

determination about significant for their specific device. 

So if you have questions about whether or not the specific change that you 

have in mind for your specific device would rise to the level of significant and 

you are having issues with applying the flow charts that we have provided in 

this guidance and you don’t find any useful examples in either one of the 

guidances then I would recommend that you reach out to the 510(k) program 

or dice and we will certainly try and help you with your specific case. 

(Carrie Plummer): Okay, thank you very much. 

Coordinator: Our next question comes from (Jennifer) with Cipco Radiotherapy. Your line 

is open. 

(Jennifer): Hi, thank you. Our question is in regards to a software change. Looking at 

example 2.1 from the software guidance, if we’re making a change to a device 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 30

to restore it to the original specifications, but we want to push that change out 

to users in the field, that’s effectively recalling the current version of the 

software, would the decision in that example still be documentation or would 

that require a new 510(k)? 

Linda Ricci: So this guidance doesn’t really talk about what would require a recall versus 

what would not. In this specific example we’re talking about whether or not a 

new 510(k) would be required because it’s changing back to the original 

specification. If there’s a significant recall associated with an error that’s in 

the field, it may need a recall and that is not determined by this guidance. 

(Jennifer): So I may need to actually clarify, I’m not looking for a recall determination. 

We would – we’re making a change to software to restore it to original 

specifications, that we would then recall the current version in the field, so 

would the recall itself trigger the 510(k), or we can say solely that it’s 

intended to restore a system to original specifications? 

Linda Ricci: So the other thing to look at as discussing question two is, is there a 

significant impact to the device? The language in question two was meant to 

allow manufacturers to make small changes to their device to return them to 

specifications, and particularly changes that don’t have an impact to the safety 

or effectiveness of the device. 

If you’re looking at needing to recall all of your devices in the field then I 

would consider that you would need to think about whether or not you’re 

having a significant impact to the safety or effectiveness of the device. I mean 

oftentimes there can be other reasons for doing recalls you know, and 

particularly not using – you know, if you wanted to update every item in the 

field that – and it may or may not reach the level of a recall. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 31

But I would consider if the changes that you are making even though it’s 

returning the device to its original specification, if that change is actually 

having a significant impact on the safety or effectiveness of the device, then 

question two would lead you down to go to question three. 

(Jennifer): Okay, thank you. 

Coordinator: Our next question comes from (Melissa Masters). Your line is open. 

(Melissa), we’re unable to hear you in conference. Could you please check 

your mute button? 

(Melissa Masters):Hi, this is for (Unintelligible). 

Coordinator: Yes, your line is open. 

(Melissa Masters):All right, thank you, thank you for taking my question. So the question I have 

is trying to think the flow chart with the guiding principles. If a change is not 

intended to improve or affect the safety and effectiveness of the device, is the 

flow that we then move onto the next stages, or is it initial risk based 

assessment have to be done even if the intent was not to change or modify the 

safety and effectiveness of the device? 

Rebecca Nipper: If the intent was not to significantly affect the safety or effectiveness of the 

device, you would move on to the other sections of the guidance, and so the –

when we – in the guiding principles when we talk about conducting an initial 

risk based assessment, that’s meant to reflect the assessment they are making 

using either any combination of the sections within the guidance. So you 

know, whether it’s the materials section or the labeling section or some 

combination, that would be your initial risk based assessment. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 32

(Melissa Masters):Okay, great, thank you. 

Coordinator: Next question comes from (Laurie Cartwright). Your line is open. 

(Laurie Cartwright): Hi, thank you for taking my question. I have a question related to the 

software guidance and the changes being affected. If there was a recall related 

to a potential event and then the software was modified to reduce the 

likelihood of that event, would that be something that we would do under the 

changes being affected? I guess my main question is, is that something where 

we can implement that change to the field prior to 510(k) clearance? 

Linda Ricci: Thank you for that question. It appears that that question specifically is going 

to be outside the scope of this guidance, and I would encourage you to contact 

the 510(k) program or the dice program to ask that question specifically. 

(Laurie Cartwright): Okay, thank you. 

Coordinator: Our next question comes from (Christina Merrick). Your line is open. 

(Christina Merrick): Hello, my question has really more to deal with when do you apply the 

principles. If your change control process has determined the change is minor 

in nature, so like, something really minor like you’re fixing formatting or 

other lesser changes to the product, is that process there significant enough 

that you don’t have to move through and like do the full documentation 

process of is safety and effectiveness you know, even affected because the 

beginning change is so minor in nature? 

Rebecca Nipper: I think even minor changes are within the scope of the guidance, but if you 

look in appendix B, I think you would see an example of where very minor 

changes can be handled with a minimal set of documentation. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 33

(Christina Merrick): Thank you. 

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

(Richard Lordo): Hello, thanks for taking my question. This pertains to labeling related 

changes. If you have a group of products that have been developed over time 

and all have their own individual 510(k) clearance numbers, yet they’re all 

products that are the same intended use, same patient population. 

If at some point you look to consolidate warnings and cautions for consistency 

in that patient population, along with your other risk management activities, is 

relying on the more recent 510(k) decisions an acceptable input to the 

decision-making process as one would assume it represents the agency’s 

current thinking and current agreement with your most recent products being 

submitted as a reason to come up with a good consolidated set and consistent 

set of warnings and cautions for users? 

Rebecca Nipper: Let me make sure I understand your question. So are you saying that if you 

were looking to update a product set of labeling, you’re asking if whatever the 

most recently cleared version of labeling is would be an appropriate baseline 

for deciding to make those changes? 

(Richard Lordo): To support making the changes, not as the input to the decision, but as you go 

through it, you do your other risk management activities, but additionally 

indicating well that’s been the most recently cleared language that you know, 

would reflect up to date standards, recognition, all those sorts of things across 

the product family where the indications for use are the same, the patient 

population’s the same, all that sort of stuff. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 34

Rebecca Nipper: Okay, I understand. So I think you would need to go back to whatever the 

most recently cleared 510(k) is for each product. If you can say that they’re all 

within the same product family you may be able to make the case that the 

most recently cleared submission applies to all of them, but I would examine 

closely if there are differences between your most recently cleared submission 

and one that is further back in the product history that may have more 

outdated labeling and whether or not a new submission is needed for one of 

those older pieces of the family. 

(Richard Lordo): Okay, thank you.

Coordinator: Our next question comes from (Jan). Your line is open. 

(Jan): Hi, thank you for taking the question. Somebody mentioned that the guidance 

is in line with previous guidances, but what would be a reasonable time for the 

transition of these new guidelines? 

Linda Ricci: So as was mentioned previously this guidance is now in final. We expect that 

this guidance represents that practice that has been underway in the industry 

for many years has – is a basically a clarification of the K97 that was active 

for a very long time. So this is a final guidance and this is the current guidance 

that FDA is acting upon. 

(Jan): Yes and what does it mean in practice that we are – yes, if we would for 

example get a control that we will be not in line with the guidance since we 

haven’t done this yet or...

Linda Ricci: We expect manufacturers to use this guidance from now going forward for 

changes that they make to their devices. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 35

(Jan): But it should be applied to retrospective as well. 

Rebecca Nipper: I think we’re having difficulty understanding your question a little bit, so if 

you could send your question to the 510(k) program or to dice, I think we can 

better help you answer your question. 

(Jan): Okay. 

Coordinator: Our next question comes from (Dau-Jan Huang). Your line is open. 

(Dau-Jan Huang): Hi, thank you for taking my call. This question is related to the software 

modification guidance, and the section mentioned common software type 

change, the OS change, operating system change mentioned both in the 

infrastructure and the architecture. This is just getting confirmation that for the 

employees, the software change, changing from a Windows say XP to 

Windows 10, that’s incremental update. 

We determined it won’t significant – make significant impact or changing the 

safety of that (unintelligible) a 510(k) is not required, but on the contract if it’s 

to do with the nature of the operating system, if we are changing from 

Windows to Mac OS, then it’s highly likely a 510(k) will apply. I just would 

like FDA input on how to determine if it’s to do with infrastructure or it’s to 

do with the architecture. 

Linda Ricci: Sure, so changes to OS can be complicated, certainly. There are a number of 

software applications that use significant portions of the OS, such that a 

change to a different OS even if it’s in the same family could have a 

significant impact on safety and effectiveness. So there could be situations in 

which going from XP to Windows 10 actually would require a 510(k). 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 36

This should come out in your risk analysis or in your thinking through you 

know, how you’re using the various parts of the operating system. However 

there are also many situations in which the application really rides on top of 

the OS and the changes to the OS would not have a significant impact and can 

be easily mitigated using the existing risk control measures that are already in 

place. 

In those cases then I would agree with you that the change to the OS would 

not likely require a 510(k). It’s harder to make that argument when changing 

drastically from one OS family to another as you have indicated, like going 

from Microsoft OS to a Apple OS for example, but really it’s important to 

look at what your application is using with regards to the OS and the 

underlying drivers associated with that OS to make the determination on if 

you’re having a significant impact as a result of the change. Does that make 

sense? 

(Dau-Jan Huang): Yes, this is very helpful. Thank you. 

Coordinator: Our next question comes from (Abby McCurgy), your line is open. 

(Abby McCurgy): Hi, this question is on behalf of Ward surgical and Beverley related to change 

in core algorithms, so if we were to make minor changes to the core 

algorithm, maybe just changing numbers or some minor changes to the 

parameters without significantly affecting the performance spec, what would 

be a part or maybe improving the performance spec, what would be a part 

around the impact on the 510(k) filing? 

Like would we need to file a new 510(k), and also wanted to get your thought 

process around how to document like changes in effectiveness, like we 

understand safety from item 4971, but the risk assessment, the concept that’s 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 37

been introduced, what are FDA’s thoughts on how do we document those 

types of that there is no change in performance or impact on performance that 

is significant? Thank you. 

Linda Ricci: So when you’re looking at core algorithms and one of the reasons that we 

wanted to put it in that common software change types is exactly for the 

reasons that you have indicated. It is not uncommon to have an algorithm 

that’s implemented in software to be tweaked over time. Certainly there can 

be small changes that are made that do not have a significant impact on the 

performance of the device. 

And that is the reason that we identified them in the common software change 

types and not specifically in the flow chart as having a yes or no answer. 

Certainly there are aspects of core algorithm changes that could have an 

impact on either safety or effectiveness depending on the change that it’s 

made and the clinical implication of that change. 

Certainly if you’re looking at changing things such as the specifications, or 

excuse me, the sensitivity or specificity of your algorithm such that a different 

decision would be made than was originally provided in the original 510(k), 

then I think you would need to look more closely at how that different 

decision would impact either the safety or effectiveness. 

So in thinking about core algorithms, it’s not just that you’re making coding 

changes to the core algorithm or tweaking the performance characteristics, but 

it’s rather what is the impact of those performance characteristics on the safety 

and effectiveness of the device as a whole. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 38

(Abby McCurgy): That’s very helpful, thank you, and also wanted to get your thoughts on 

documenting changes in performance or effectiveness just in general from the 

general guidance document as well. 

Rebecca Nipper: I think if you look in Appendix B we’ve given some examples of how you 

would document whether or not a new submission is necessary, including 

whether or not there are changes to the effectiveness, and so I would 

encourage you to look in Appendix B and see if that is helpful. 

(Abby McCurgy): Okay, thank you. 

Coordinator: The next question comes from (Jody Sing), your line is open. 

(Jody Sing): Hi, thank you for taking my question. My question is in regard to, the 

guidance says to assess the cumulative effect of changes and compare it with 

the recently cleared 510(k) and with the changed device. Could you share 

some thought on assessing the cumulative effect, and also I have an additional 

follow-up to this. If you can share, what does FDA expect when the guidance 

mentions comparison with the recently cleared 510(k) and the modified device 

where this is not a substantial equivalence change, but a comparison of the 

change, so what’s the expectation there? 

Rebecca Nipper: So what we’re trying to say is that – so say you had device A that was 

originally cleared in your 510(k), and then you made changes in versions B 

and C that did not require submission of a 510(k) and now you have version D 

that you’re assessing as to whether or not a new submission is needed. So 

when you look at version D of the device, you want to compare that device as 

it stands back to the original device and look at where the device is now 

including all of the changes that have taken place over time. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 39

And so that’s what we mean when we say that you would assess the 

cumulative effectiveness changes, even if individually they did not require a 

submission. Did you have another question? 

(Jody Sing): And my follow up question was about comparison for example the guidance 

says consider including a tabular form of comparison between the 510(k) and 

the modified device, but this is not necessarily a substantial equivalent 

comparison, so what is FDA looking at, what kind of comparison should be 

included if a table is included? 

Linda Ricci: When we’re looking at listing of the changes that have been made since the 

original 510(k), that’s really what we’re looking at. We just want to know 

what changes have been made. It certainly makes it easier for FDA to 

understand the transition that this device has gone through since its last 

clearance. 

Now we’re not looking at that list of changes purely in a substantial 

equivalence determination, although when it’s part of a 510(k) we will use 

that information and the supporting documentation along for those changes in 

our assessment of substantial equivalence. So really we’re just looking for you 

to document the list of changes that you have made to your device since its 

last clearance. Does that help?

(Jody Sing): Yes, definitely. One more thing I wanted to clarify, the list of changes may 

not necessarily be the same that were listed in the previously cleared 510(k), 

they may be totally different, but because these are minor changes that may 

not require a 510(k). So you’re just looking at the change between the 

previous one and the current one, not necessarily what we listed during the 

substantial equivalence. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 40

Linda Ricci: That’s right, it’s going back to Rebecca’s example where you have version A

of a device, and that’s the one that was cleared, and then you make versions B 

and version C, neither of which required a new 510(k), and then you go to 

version D and when you’re assessing version D and you’re comparing it to 

version A, you determine that you need a new 510(k). 

We would expect you to provide the information on versions B and C in your 

submission for version D. Now if you went onto version E and version E also 

required a new 510(k) because version D had a 510(k) we would not expect 

you to list versions B and C for E. 

(Jody Sing): Thank you. That’s very helpful. 

Coordinator: Our next question comes from (Laura Cosferowitz). Your line is open. 

(Laura Cosferowitz): Hello, thank you for taking my question. I too would like to say thank you 

to the agency for the time and effort to develop this new guidance. I do have a 

question, not yet asked, although similar to the last question, the 510(k)

guidance addresses individual changes implemented at a single point in time, 

but it does not discuss the incremental non-significant changes that could in 

some be significant when evaluating an established device. 

So the 510(k) to bring FDA up to date on non-significant changes 

implemented since the last 510(k) clearance is often referred to by industry as 

a catch-up 510(k), and a 510(k) that is a catch-up is not explicitly described in 

the guidance, so with the new guidance is the agency in essence encouraging 

industry to use catch-up 510(k)s as a more common practice, or what does the 

agency anticipate in regard to product changes that had previously been 

documented internally such as you know, in a letter to file? 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 41

Rebecca Nipper: So I don’t think our policy or expectations have changed in comparison to the 

K97 guidance or we didn’t intend for them to change. We do know that 

sometimes manufacturers choose to submit a catch-up 510(k), we are familiar 

with that, but really this guidance doesn’t speak to those. It only speaks to 

changes or deciding when a 510(k) is required for a change to a device. 

And so if a catch-up 510(k) is submitted, that includes a number of changes 

that have occurred since the previous clearance, which were not necessary for 

submission, if there was no triggering change that required the need for a 

510(k), then those – that catch-up 510(k) or the concept is kind of outside the 

scope of this guidance. 

(Laura Cosferowitz): Yes, I realize that it’s outside of the scope. I realize that it wasn’t 

discussed. Is it going to be discussed in – or you know, in another guidance 

or...

Rebecca Nipper: No, I don’t think our expectations or our policy around that – the practice of a 

catch-up 510(k). I don’t think that has changed, so I don’t think we really have 

anything to add in comparison to where we were previously. 

(Laura Cosferowitz): Okay, so the agency doesn’t anticipate that this is – that the new guidance 

is going to cause industry to need to do this more. 

Rebecca Nipper: No, we don’t think it will change anything in that regard. 

(Laura Cosferowitz): Okay, thank you. 

Coordinator: The next question comes from (Mark McCarty). Your line is open. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 42

(Mark McCarty): Hi, thanks for taking this question. As probably everybody at FDA knows, 

ISO is looking at a re-write of 14971, which obviously affects a lot more 

guidances and so on and so forth than just these two. 

Is there any expectation on FDA’s part that the final re-write of 14971 would 

require that FDA revisit the guidances in which 14971 is cited, or should it be 

a situation in which a device may simply take the new 14971 whenever it 

comes out and bolt it into their operations and the citations of 14971 in FDA 

guidances are general enough that they shouldn’t require a new 510(k), 

require a new FDA guidance to accommodate those changes. 

Linda Ricci: Certainly there’s a number of cross-cutting standards for which we could 

describe this practice, 14971 is definitely one of them, and while this doesn’t 

apply specifically to the mods guidance that we’re here talking about today, 

we do participate and actively talk about standards both within our guidances 

and in our practices and policies. 

And look to make sure that our guidances are you know, as we referenced 

those standards are consistent, so whether or not a guidance, a specific 

guidance would need to change would depend on what the changes to any 

specific standard were and how it was referenced in the guidance. 

Rebecca Nipper: Yes, and that being said, because of the way we reference ISO 14971 in the 

modifications guidance and this guidance specifically, I think the concept 

would still apply. We just referenced it because it’s a document with which 

manufacturers are familiar, and so when we were talking about a risk based 

assessment it provided some terminology that manufacturers were familiar 

with. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 43

(Mark McCarty): Okay, are you – is there any movement afoot for ISO to you know, move a 

little bit more towards you know, common terminology with FDA, or is 

everybody pretty much set in their ways and there’s no perceived need for the 

terminology used by FDA and the terminology used by ISO to be aligned in 

any way shape or form. 

Linda Ricci: Yes, that’s a whole other conversation. So – and I am sorry that that is beyond 

what we need to talk about today for this guidance. 

(Mark McCarty): Okay, thank you very much. 

Coordinator: Next question comes from (Melissa Clamriss), your line is open. 

(Melissa Clamriss): Hello, thanks for taking my call. My question has to do with the general 

guidance and material changes, so I’m on flow chart C, and in particular the 

C3 questions, and the definition around tissue. I’m wondering if that – the 

definition for tissue aligns with ISO 10993. When I read the example 

associated with C3, it seems to perhaps go beyond the tissue and otherwise 

being sterile parts of the body and may include intact skin. Could you clarify 

that definition, please. 

Rebecca Nipper: I think – I don’t think our intent was to redefine the terminology of tissue in 

comparison to ISO 10993, but I think generally when we refer to tissue, we 

refer to it more generally as far as not just internal sterile parts of the body, 

but also intact skin. 

(Melissa Clamriss): Okay, thank you for the clarification. 

Coordinator: Thank you, and our last question comes from (Judy Perrins), your line is open. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 44

(Judy Perrins): Hi, thank you for taking my questions. I have two questions. The first is 

regarding manufacturing changes. Since manufacture has many manufacturing 

changes, and I realize the guidance document talks about the new two 

guidance documents that not specifically address manufacturing changes, and 

however I would like to have FDA’s guidance on the need – especially for 

those manufacturing changes that does not impact the labeling or engineering 

or technology, or material aspect. So what is FDA’s expectation for 

manufacture to use the flow chart to assess those changes and what is 

expectation on the documentation? 

Rebecca Nipper: With a few exceptions that we do mention in the guidance, manufacturing 

review is outside the scope of a 510(k) review, and therefore manufacturing 

changes are also outside the scope of this guidance. 

(Judy Perrins): Okay, so that means that if manufacture can document those manufacturing 

changes with the existing quality systems, documentation requirement that 

should be sufficient, not required to go to use involve flow chart to assess for 

a 510(k) or not too far, or (unintelligible) too far, correct? 

Rebecca Nipper: If it is strictly a manufacturing change, it is likely outside the scope of this 

guidance. If the manufacturing change causes you to change some other part 

of your device such as the labeling, or the device specifications, then you 

would likely be – you would need to use this guidance to assess your changes. 

(Judy Perrins): Okay, thank you. So my second question is regarding accumulative changes 

from last 510(k) clearance. So since we may have some changes between 

510(k) submission to the 510(k) clearance, that window, several month 

window manufacturer also make some changes, so that these accumulated 

changes the window means the classic 510(k) submission, not classic 510(k)

clearance. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 45

Rebecca Nipper: So are you saying you would have two 510(k)s in house at the same time? 

(Judy Perrins): No. For an existing 510(k) we had already a market and we are making 

modifications to that device for example if we make submission in April of 

this year and this device is cleared in September or October of this year, they 

may have some changes happening between that time window, so next note 

too far, what if the time (unintelligible) for the accumulated changes? Is that 

our submission of 510(k) of April of this year or since the clearance of 510(k)

in September or October of this year? 

Linda Ricci: We’re talking about cumulative changes when we talk about the most recently 

cleared 510(k), we’re not talking about a date, we’re talking about a version of 

the device. So the version of the device that you submitted in April is the 

version of the device that would be under review and in your example was 

cleared in September. 

So the version that you are changing between April and September is not the 

version that you submitted in April. So we’re talking about the version of the 

device and not the time that the device was cleared. Does that make sense? 

(Judy Perrins): So the version should be in October of that device. 

Linda Ricci: No, the version would be the version that you submitted in your 510(k). 

(Judy Perrins): Okay, that should be in April. 

Linda Ricci: It’s the version that was submitted in your 510(k), and then that was cleared, 

that’s the version that was cleared, so any changes made between April and 

September were not part of your 510(k) under review. 
NWX-FDA OC

Moderator: Irene Aihie

11-16-17/1:00 pm ET

Page 46

(Judy Perrins): Yes, okay. Thank you. 

Coordinator: Thank you, that was our last question so I will turn it over to Irene for closing 

remarks. 

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 PDRH learn Web page at www.fda.gov/training/pdrhlearn by 

Wednesday, November 29th. 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 the 

Webinar, please complete a short 13-question survey about your FDA CDRH 

Webinar experience. The survey can be found at www.fda.gov/pdrhwebinar 

immediately following the conclusion of today’s live Webinar. Again, thank 

you for participating. This concludes today’s Webinar. 

Coordinator: Thank you. That concludes today’s conference. Thank you for participating. 

You may disconnect at this time. 

END