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Today’s Topic: 

CDRH's New Draft Guidances to Continue to 

Modernize the 510(k) Program

October 26, 2023
CDRH's New Draft Guidances to Continue to 

Modernize the 510(k) Program

Megha Reddy, MBA 

Regulatory Advisor

Regulatory, Policy, and Guidance Staff

Office of Product Evaluation and Quality

Mary Wen, PhD 

Deputy Director

Division of Submission Support

Office of Product Evaluation and Quality

Peter Yang, PhD, RAC 

De Novo Program Lead

Division of Submission Support

Office of Product Evaluation and Quality

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Modernization of the 510(k) Program

Megha Reddy, MBA 

Regulatory Advisor

Regulatory, Policy, and Guidance Staff

Office of Product Evaluation and Quality
CDRH's New Draft Guidances to Continue to 

Modernize the 510(k) Program

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification 

[510(k)] Submission 

– www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selectingpredicate-device-support-premarket-notification-510k-submission

• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] 

Submissions

– www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-use-clinicaldata-premarket-notification-510k-submissions

• Evidentiary Expectations for 510(k) Implant Devices

– www.fda.gov/regulatory-information/search-fda-guidance-documents/evidentiary-expectations-510kimplant-devices

These are draft guidances and are not for implementation; submit comments by 12/6/23
CDRH Continues to Modernize the 

510(k) Program

2011

CDRH Plan of Action 

for 510(k) and Science

2014

510(k) Program

Guidance

2018

Medical Device Safety 

Action Plan

From 2009 - 2023, CDRH has issued more than 100 final cross - cutting and device - specific 

guidances to clarify expectations for 510(k) review 5
CDRH’s Request for Feedback to Strengthen 

510(k) Program

Opened docket for feedback on: 

• FDA’s proposal to post on its website a list 

of FDA - cleared devices that demonstrated 

substantial equivalence to older predicate 

devices 

• Actions that FDA should take to promote 

development and marketing of safer, 

more effective 510(k) devices 

• If FDA should consider actions that may 

require new authority, such as making 

some older devices ineligible as 

predicates

FDA has continually reviewed feedback gathered to modernize the 510(k) Program to spur 

innovation and create safer devices for patients 6
Comments Received on CDRH’s 

Request for Feedback

Feedback received through the docket spurred the development of 3 new draft guidances to 

improve the predictability, consistency, and transparency of the 510(k) Program: 

• Received feedback that focusing on only older predicates may not optimally promote safer and 

more effective devices (such as implants, which may have a long history of safe use)

• In our new draft guidance “Best Practices for Selecting a Predicate Device to Support a 510(k) 

Submission,” we recommend utilizing “best practices” when selecting a predicate device rather 

than solely focusing on the predicate’s age

• Also received feedback that clarity and transparency would be helpful on the topics of clinical 

data in 510(k) submissions and recommendations for 510(k) implants

• Drafted 2 new guidances focused on these topic areas:

– Recommendations for the Use of Clinical Data in 510(k) Submissions

– Evidentiary Expectations for 510(k) Implant Devices

7
ü Describe how these new draft guidances can 

help improve the predictability, consistency, 

and transparency of the 510(k) Program 

ü Explain how these new draft guidances are 

consistent with the 510(k) Program Guidance

ü Explain the current policies in the new draft 

guidances, including: 

ü FDA’s proposal on the 4 best practices for 

selecting a predicate device to support a 510(k) 

ü Proposed recommendations for when clinical 

data may be needed to demonstrate substantial 

equivalence 

ü Proposed general recommendations and 

evidentiary expectations for all 510(k) implants

8
Draft Guidance 

Best Practices for Selecting a Predicate 

Device to Support a Premarket Notification 

[510(k)] Submission

9
Best Practices for Selecting a Predicate 

Device to Support a 510(k)

• Provides recommendations on the best practices for choosing a predicate 

device to support a 510(k) submission 

• The use of best practices when selecting a predicate device is intended to: 

– Encourage the evolution of safer and more effective medical devices in 

the 510(k) Program 

– Encourage submitters to consider the characteristics of the predicate 

device rather than focusing on the age of the predicate

10
When to Use the Best Practices

• Guidance is intended to be used while a submitter 

is preparing their 510(k) submission to assist with 

the identification of potential predicate devices 

• In selecting your predicate device for your 510(k) 

submission: 

1. Determine the list of legally marketed devices 

2. Consider, of the legally marketed devices, 

which could be considered a “valid predicate 

device” 

3. Use the best practices to help determine your 

predicate device to support your 510(k) 

submission

L

Legally Marketed Devices

Valid Predicate Device(s)

Predicate(s) chosen after 

considering best practices

11
Proposed Best Practices when 

Selecting a Predicate Device

12

Predicate devices 

cleared using wellestablished 

methods

Predicate devices 

meet or exceed 

expected safety 

and performance

Predicate devices 

without 

unmitigated userelated or designrelated safety 

issues

Predicate devices 

without an 

associated designrelated recall
Predicate Device(s) Cleared Using 

Well-established Methods

• FDA recommends selecting a valid predicate device that was cleared using well - established 

methods, which can include those from: 

Currently FDA-recognized voluntary consensus standards

FDA guidance documents

Qualified medical device development tools (MDDTs)

Widely available and accepted methods published in the public domain or scientific 

literature for the context of use, or found acceptable through the submitter’s own previous 

premarket submission 

• Selecting a predicate device cleared using well - established methods can help ensure that the 

subject device is evaluated using updated scientific methods whenever possible

13
Predicate Device(s) Meet or Exceed 

Expected Safety and Performance

• New information about a device’s safety and/or effectiveness, 

unanticipated adverse events, subsequent changes to the 

device, or other types of information may become available as 

a device is more widely distributed and used 

• FDA recommends searching our databases for reports of injury, 

death, or malfunctions: 

– Manufacturer and User Facility Device Experience 

(MAUDE) Database

– Medical Device Reporting (MDR) Database

– MedSun Reports Database
Predicate Device(s) Without Unmitigated 

Use-related or Design-related Safety Issues

• New information about a device can become available once the device is more widely 

distributed and used, which could represent an emerging signal 

• An emerging signal may represent new information about a device, such as a new 

association between a device and an adverse event or set of adverse events

• FDA recommends searching our websites for information 

about safety signals, emerging signals, or other safety 

communications: 

– Medical Device Safety Communications

– CBER Safety & Availability (Biologics) 

Communications

15
Predicate Device(s) Without an Associated 

Design-related Recall

• Recalls can occur due to: 

– Design defects, 

– Manufacturing defects, or 

– Labeling defects 

• Design - related recalls can indicate a flaw with 

the design of the device as cleared and 

commercially distributed 

• To assess whether any of the valid predicate 

device(s) have an associated recall, FDA 

recommends conducting a search in the 

Medical Device Recalls Database

16
Improving Transparency of Predicate Devices

The 510(k) Summary provides a summary of the device, including any information regarding 

safety and effectiveness, and the basis for a determination of substantial equivalence 

(see 21 CFR 807.92 and Appendix B of the 510(k) Program Guidance)

FDA recommends that submitters include in their 510(k) Summary:

An explanation regarding their selection of the predicate device(s) used to support the 

510(k) submission; and 

A narrative of how the best practices were used to select the predicate device(s) 

proposed for use in the 510(k) submission; or 

If a submitter cannot identify a valid predicate device consistent with the best practices: 

A statement that a valid predicate device that is consistent with any of the best practices 

was not available; and 

Summary performance data to describe the testing conducted to address any known 

safety or effectiveness concerns with the predicate device 17
Example: Bone Sonometer Associated with a 

Design-Related Recall

Example Scenario:

A submitter is preparing a 510(k) for a 

bone sonometer. The submitter only 

identified one valid predicate device. 

The valid predicate device: 

• Used currently FDA - recognized 

versions of applicable consensus 

standards 

• Has an expected frequency of 

reported adverse events 

• Had no known unmitigated userelated or design - related safety issues 

• Has been associated with a designrelated recall

What does the Submitter do?

In their 510(k) submission: 

• References selected predicate device, along with a 

statement that it was the only valid predicate device that 

could be identified 

• Describes performance testing conducted and the 

measures taken to mitigate the safety concerns relevant to 

the design-related recall

In their 510(k) summary:

• Identifies predicate device, and that it is the subject of a 

design - related recall 

• Summarizes selection process of the predicate device 

• Summarizes performance testing conducted to address 

safety concerns relevant to the design-related recall
Summary of Proposed Best Practices when 

Selecting a Predicate Device

Predicate devices 

cleared using wellestablished 

methods

Predicate devices 

meet or exceed 

expected safety 

and performance

Predicate devices 

without 

unmitigated userelated or designrelated safety 

issues

Predicate devices 

without an 

associated designrelated recall

The use of best practices when selecting a predicate device is intended to encourage the 

evolution of safer and more effective medical devices in the 510(k) Program 19
Draft Guidance 

Recommendations for the Use of 

Clinical Data in Premarket 

Notification [510(k)] Submissions

Mary Wen, PhD 

Deputy Director

Division of Submission Support

Office of Product Evaluation and Quality
Recommendations for the Use of 

Clinical Data in 510(k)s

• Provides recommendations for when clinical data may be needed in a 510(k) to 

demonstrate that a new device is substantially equivalent (SE) to a predicate device 

• FDA initially described scenarios for when clinical data may be necessary in a 510(k) 

to demonstrate SE in the 510(k) Program Guidance, Section IV.F., “Requests for 

Performance Data” 

• Clarifies and provides additional context for situations when clinical data may be 

necessary to demonstrate SE by providing examples to clarify these concepts, 

illustrating when clinical data may or may not be needed 

• These broad considerations may help provide predictability and transparency about 

when clinical data may be necessary in a 510(k)

21
When Clinical Data is Typically Reviewed

As initially described in the 510(k) Program Guidance, 

clinical data may be used during the 510(k) review process 

to support an SE determination at multiple points in the 

510(k) Decision-Making Flowchart: 

• Typically, clinical data is reviewed after we find that the 

intended use of the new device and the predicate device 

are the same, and that the devices have different 

technological characteristics that do not raise different 

questions of safety and effectiveness 

• In such cases, clinical data often is used to determine 

whether the new device is “as safe and effective” as a 

predicate device

This is the most common use of clinical data in a 510(k)

22
When Clinical Data is Typically Reviewed

The 510(k) Program Guidance also describes other 

points at which clinical data may be used during the 

510(k) review process to support an SE 

determination. For example: 

• In rare instances, FDA may rely upon clinical data 

to determine that new or modified indications for 

use fall within the same intended use as a 

predicate device

23
When Clinical Data is Typically Reviewed

As initially described in the 510(k) Program Guidance, 

clinical data may be used during the 510(k) review process 

to support an SE determination at multiple points in the 

510(k) Decision - Making Flowchart: 

• Typically, clinical data is reviewed after FDA finds that 

the intended use of the new device and the predicate 

device are the same, and that the devices have different 

technological characteristics that do not raise different 

questions of safety and effectiveness 

• In such cases, clinical data often is used to determine 

whether the new device is “as safe and effective” as a 

predicate device 

• This is the most common use of clinical data in a 510(k)

This guidance focuses on 

the more common uses of 

clinical data in a 510(k) to 

demonstrate SE

24
Scenarios When Clinical Data May be 

Necessary to Determine SE

There are 

differences between 

the indications for 

use of the new 

device and the 

predicate device

1

There are 

differences between 

technological 

characteristics of 

the new device and 

the predicate device

2

SE between the new 

device and the 

predicate device 

cannot be 

determined by non - 

clinical testing 

(analytical, bench, 

and/or animal)

3

A newly identified 

or increased risk for 

the predicate device 

suggests clinical 

data may be needed 

for the new device

4

25
Differences in Indications for Use (IFU)

• When the IFU of a new device and predicate device differ, we must evaluate whether 

the IFU of the new device fall within the same intended use as that of the predicate 

device 

• We determine the IFU of the new device based on: 

– Proposed labeling 

– IFU statement 

• However, we may also rely upon other clinical and/or 

scientific information submitted with the 510(k)

PROPOSED 

LABELING

26
Differences in IFU

• Clinical data may be necessary to include in a 510(k) to demonstrate SE when there 

are differences between the IFU of the new device and the predicate device 

• FDA recommends considering the following factors: 

– Differences in the patient population 

– Differences in the disease 

– Differences in the anatomical site, structure, or pathology 

– General to specific considerations 

– Expansion of the new device’s currently - cleared IFU 

– Unknown or different benefit-risk profile for the proposed IFU 27
Examples: Differences in IFU

Example 1-B:

• Device indicated for use in a specific anatomic 

location in proximity to critical organs 

• Manufacturer wants to pursue an IFU in a 

different anatomic location that does not 

represent a new intended use and does not 

pose additional or different risks

Non-clinical data may suffice to demonstrate SE: 

• IFU for the predicate device represents a 

higher/similar risk scenario than the new 

device 

• Benefit - risk profile of the new device with the 

expanded IFU is comparable to that of the 

predicate device

Example 1-C:

• Device indicated for use in a specific 

anatomic location 

• Manufacturer wants to expand the IFU to a 

different anatomic location for the same 

intended use 

• Based on literature and through clinical 

experience, using the device in this new 

anatomic location presents an increased risk 

because the procedure is technically complex

Clinical data may be necessary to demonstrate SE: 

• Increased risk may adversely affect the benefitrisk profile of the new device when compared 

to the predicate device

28
Differences in Technological 

Characteristics

• Clinical data may be necessary to include in a 510(k) to demonstrate SE when there are 

differences in technological characteristics of the new device and the predicate device 

• FDA recommends considering the following factors: 

– Significant change in materials 

– Significant change in device design 

– Significant change in energy source 

– Significant change in other device features

29
Examples: Differences in Technological 

Characteristics

Example 2-C:

Manufacturer wants to add additional sizes of an implanted device to its existing line of 

cleared, implanted devices

If the new sizes are within the minimum and maximum of the cleared, implanted devices, nonclinical data may suffice to demonstrate SE: 

• New devices can be assessed using non-clinical testing methods

If the size of the new implanted device would be the new minimum/maximum of the cleared, 

implanted devices, clinical data may be necessary to demonstrate SE: 

• Change in technological characteristic is expanding the range of device sizes

30
SE Cannot be Determined by 

Non-clinical Testing

• Clinical data may be necessary to include in a 510(k) when non - clinical testing, such as 

analytical, bench, and/or animal testing, is not adequate to establish that the new 

device is SE to the predicate 

• FDA recommends considering the following factors:

– There is no model available (such as analytical, bench, animal) 

– The available model(s) may not be adequate because the model has certain 

limitations that do not allow for an adequate assessment

– The model may not be predictive of clinical outcomes

– There are anatomical and/or pathophysiological species - specific questions that 

rely on clinical evidence 31
Examples: SE Cannot be Determined by 

Non-clinical Testing

Example 3-A:

Device intended to treat schizophrenia

Clinical data may be necessary to demonstrate SE

Example 3-D:

: 

• Limited availability of non - clinical models for 

schizophrenia

Device intended to screen donors of blood and blood 

products for transfusion-transmitted infections

Clinical data may be necessary to demonstrate SE: 

• Analytical testing cannot be used to: 

• Evaluate clinical performance of assay 

• Evaluate the risks to the blood supply 

associated with incorrect results

Example 3-E:

IVD intended for point - of - care use where the 

predicate device is not intended for point-of-care use

Clinical data may be necessary to demonstrate SE: 

• Variety of clinical environments 

• Diverse populations that may use the device

32
Newly Identified or Increased Risk 

for Predicate

• As a device is more widely distributed and used, new scientific information about a 

device’s safety may become available, which could include newly identified or 

increased risk

• New scientific information may affect the type and level of performance data needed 

in a 510(k) 

• In requests for clinical data due to a new/increased risk, we will provide an explanation 

of the reason(s) for the request and why such information is necessary for the SE 

determination 

• If possible, manufacturers should not use certain devices as predicates if they exhibit a 

new/increased risk, especially if an alternative predicate device exists without such 

new/increased risk 33
34

Recalls, voluntarily - reported adverse events, and 

published scientific literature has made FDA aware 

of certain malfunctions for a device

Examples: Newly Identified or 

Increased Risk for Predicate

Example 4-A:

Based on FDA’s assessment of the totality of 

clinical and non - clinical data, non - clinical data 

may suffice to demonstrate SE: 

• Non - clinical testing and appropriate 

instructions for use could demonstrate 

whether the risk is adequately mitigated by its 

design and technological features

Example 4-C:

• Device issue reported that could lead to 

significant patient injury in surgical procedures 

• Primary evidence in current 510(k)s is nonclinical design verification and validation 

testing of the technological characteristics of 

the device 

• Manufacturer recalled device with issue, and 

submitted a new 510(k) to address the issue; 

new 510(k) included non - clinical and clinical 

performance data

FDA issued device - specific guidance to outline 

recommendations for non - clinical and clinical 

performance testing for this device type
Summary of Clinical Data in 510(k)s

35

There are 

differences between 

the indications for 

use of the new 

device and the 

predicate device

There are 

differences between 

technological 

characteristics of 

the new device and 

the predicate device

SE between the new 

device and the 

predicate device 

cannot be 

determined by non - 

clinical testing 

(analytical, bench, 

and/or animal)

A newly identified 

or increased risk for 

the predicate device 

suggests clinical 

data may be needed 

for the new device

1 2 3 4

This guidance clarifies certain situations when clinical data may be necessary 

to demonstrate SE, and is intended to enhance the predictability, consistency, 

and transparency of the 510(k) Program
Draft Guidance 

Evidentiary Expectations for 510(k) 

Implant Devices

Peter Yang, PhD, RAC 

De Novo Program Lead

Division of Submission Support

Office of Product Evaluation and Quality
Evidentiary Expectations for 510(k) 

Implant Devices

• Provides general recommendations for all implant devices for which a 510(k) is 

required 

– Device-specific guidances may provide further specificity for a given device type

• Clarify evidentiary expectations for 510(k) implants by assisting industry in design of 

appropriate performance testing that may be necessary to support a 510(k) for 

implant devices

• Provides general recommendations for other content in a 510(k), including:

Human Factors & 

Usability Testing

Patient 

Experience 

Information

Proposed Labeling

& Implant Cards

37
What is an Implant?

An implant, as defined in 21 CFR 860.3(d), is “a device that is placed 

into a surgically or naturally formed cavity of the human body”

Further, “[a] device is regarded as an implant ... only if it is intended to 

remain implanted continuously for a period of 30 days or more...”

• The term “implant” in this guidance refers to devices intended to be implanted 

continuously for 30 days or more

• However, many of the review considerations and associated recommendations in 

this guidance are also applicable to devices that are intended to remain 

implanted continuously for fewer than 30 days 38
General Considerations for 510(k) Implants

What are the indications for use of the device? 

• Consider the specific intended patient population, disease state, and conditions of 

use when designing and conducting performance testing 

• Consider performance testing representative of the way in which the device is 

indicated to be used, including the anatomical location(s) for which it is indicated 

• Pediatric populations may have unique considerations, including whether it is 

appropriate to extrapolate adult data for pediatric use

What is the intended duration of implantation?

What is the anticipated patient and physician experience with the implant?

39
General Considerations for 510(k) Implants

What are the indications for use of the device?

What is the intended duration of implantation? 

• Consider the intended duration of implantation or of patient exposure to the device 

when designing and conducting performance testing

• Consider whether results from shorter non - clinical or clinical duration testing can 

be extrapolated to provide information about long-term performance

• Consider whether testing should be conducted to address potential implant wear 

or degradation; use “worst-case” implantation conditions

What is the anticipated patient and physician experience with the implant?

40
General Considerations for 510(k) Implants

What are the indications for use of the device?

What is the intended duration of implantation?

What is the anticipated patient and physician experience with the implant? 

• Consider both the patient and the physician experience with the implant in 

performing risk analysis and identifying performance testing 

• Such risks can include: 

Ø Risks associated with everyday activities 

Ø Risks associated with user interaction 

with the implant

Ø Risks associated with implantation procedure 

Ø Risks that may vary between different patient 

populations

41
Non - clinical Recommendations 

for 510(k) Implants

Non - clinical 

performance 

testing that is 

generally 

relevant 

across 510(k) 

Implants

Biocompatibility Sterility and 

Shelf Life

Reprocessing 

and Cleaning

Software and 

Cybersecurity

Electrical Safety 

and 

Electromagnetic 

Compatibility

MR 

Compatibility

Corrosion and 

Fatigue Degradation

Particulates and 

Coatings

Imaging / 

Radiotherapy 

Compatibility

Bench Model 

Testing and 

Engineering 

Analyses

Animal Testing

Type and quantity of non-clinical performance data to support an SE determination will vary 

depending on the device and/or device type and on the differences from the predicate device

42
Clinical and Other Recommendations 

for 510(k) Implants

Type and quantity of clinical performance 

data to support an SE determination will 

vary depending on the device and/or 

device type and on the differences from 

the predicate device 

Some recommendations, such as implant 

labeling, implant cards, and patient 

information, are important to consider for 

any 510(k) implant

Clinical Performance 

Testing (see Clinical 

Data in 510(k) 

Submissions Draft 

Guidance)

Implant Device 

Design Information

Human 

Factors/Usability 

Testing

Patient Experience 

Information

Labeling

• Instructions for use

• Implant cards and 

other patient 

information 43
Labeling Recommendations 

for 510(k) Implants

Instructions for Use

Ø A 510(k) must include proposed 

labeling describing the device, 

its intended use, and directions 

for use (21 CFR 807.87(e)) 

Ø Most implants are also generally prescription 

devices (21 CFR 801.109(d)) 

Ø Information for physician and patient about the 

implantation procedure, and benefits and risks of 

the device after implantation 

Ø Separate patient labeling may be helpful

Implant Cards 

Certain information may be helpful to provide to patients 

or caregivers as an implant ID card: 

• Implant identifying information, e.g., implant model 

name and manufacturer, and implant location 

• Device composition and patient contacting materials 

• Information on how to report malfunctions or 

adverse events 

• MR compatibility information 

Such information should be provided in a format that can 

be easily conveyed to patients

44
References

Slide 

Number(s)

Cited Resource URL

5 CDRH Plan of Action for 510(k) and Science https://public4.pagefreezer.com/browse/FDA/26-06-

2023T13:52/https:/www.fda.gov/about-fda/cdrh-reports/cdrh-planaction-510k-and-science

5, 8, 17, 

21-23, 48

The 510(k) Program: Evaluating Substantial 

Equivalence in Premarket Notifications [510(k)]

www.fda.gov/regulatory-information/search-fda-guidancedocuments/510k-program-evaluating-substantial-equivalencepremarket-notifications-510k

5 Medical Device Safety Action Plan: Protecting 

Patients, Promoting Public Health

www.fda.gov/about-fda/cdrh-reports/medical-device-safety-actionplan-protecting-patients-promoting-public-health

6 Modernizing FDA’s 510(k) Program; Establishment 

of a Public Docket; Request for Comments

www.regulations.gov/docket/FDA-2018-N-4751/document

13 FDA - Recognized Consensus Standards: Medical 

Devices

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

13 FDA Guidance Documents www.fda.gov/regulatory-information/search-fda-guidance-documents

13 Medical Device Development Tools www.fda.gov/medical-devices/medical-device-development-toolsmddt

45
References

Slide 

Number(s)

Cited Resource URL

14 Manufacturer and User Facility Device Experience 

(MAUDE) Database

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

14 Medical Device Reporting Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm

14 MedSun Reports www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/searchreporttext

.cfm

15 Medical Device Safety Communications www.fda.gov/medical-devices/medical-device-safety/safetycommunications

15 CBER Safety & Availability (Biologics) 

Communications

www.fda.gov/vaccines-blood-biologics/safety-availability-biologics

16 Medical Device Recalls www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

47 FDA-2023-D-3132 www.regulations.gov/docket/FDA-2023-D-3132

47 FDA-2023-D-3133 www.regulations.gov/docket/FDA-2023-D-3133

47 FDA-2023-D-3134 www.regulations.gov/docket/FDA-2023-D-3134

46
A Note about Draft Guidances

• You may comment on any guidance at any time 

– see 21 CFR 10.115(g)(5) 

• Please submit comments on the draft guidances before the 

comment period closes (12/6/23) to ensure that FDA considers your 

comments on the draft guidances before we begin work on the final 

guidances 

– Evidentiary Expectations for 510(k) Implant Devices: FDA-2023-D-3132

– Recommendations for the Use of Clinical Data in Premarket Notification 

[510(k)] Submissions: FDA-2023-D-3133

– Best Practices for Selecting a Predicate Device to Support a Premarket 

Notification [510(k)] Submission: FDA-2023-D-3134 47
Summary

ü Recommendations proposed in these new draft guidances are consistent with the 

510(k) Program Guidance, and do not change applicable statutory regulatory 

standards, such as how FDA evaluates SE or applicable 510(k) requirements 

ü New draft guidances provide clarity on the 510(k) Program in areas requested by 

public comment 

ü New draft guidances help improve the predictability, consistency, and transparency 

of the 510(k) Program by providing:

Recommendations on the 4 

best practices for selecting a 

predicate device

and/or

Clarity and predictability on 

when clinical data may be 

necessary in a 510(k)

General recommendations 

for 510(k) implants

48

Additional Panelists

Kathryn Drzewiecki, PhD 

Policy Advisor

Office of Policy

Joshua Nipper 

Division Director

Submission Support 

Office of Regulatory Programs 

Office of Product Evaluation and Quality

Angela DeMarco, MS

Assistant Director 

510(k), De Novo, 513(g), Device 

Determinations, &

Custom Devices Lifecycle Team

Submission Support 

Office of Regulatory Programs 

Office of Product Evaluation and Quality

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Let’s Take Your Questions

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Thanks for Joining Today!

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be available at CDRH Learn 

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today’s presentation

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