Overview of the 510(k) Process:

Guide for Third Party Reviewers

Vesa Vuniqi

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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CDRH Learn: The 510(k) Program (How to Study and Market Your Device)

fda.yorkcast.com/webcast/Play/d91af554691c4260b5eca0b2a28e636b1d

Suggested Pre-requisite
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Overview of 510(k) Process
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• Discuss history of 510(k)s and Third Party 

Review Program

• Review basic principles of 510(k) Program

• Explain 510(k) Flowchart

Learning Objectives
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History of 510(k) and

Third Party Reviews
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History of 510(k)s

• Medical Device Amendments of 1976

– Granted FDA authority to review medical devices

– Established device classifications: Class I, II, III

• Safe Medical Devices Act of 1990

– Defined substantial equivalence (SE) and special controls
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History of Third Party

Review Program

• FDA Modernization Act (FDAMA) of 1997

– established Third Party 510(k) Pathway

• FDA Reauthorization Act of 2017 (FDARA) 

– identified program goals to strengthen the use of the Third 

Party Review Program
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Basic Principles of 

510(k) Program
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What is a 510(k)?

• Premarket notification submission to FDA

• Demonstrates a device is substantially equivalent (SE)

– “as safe and effective”

• To a legally marketed device 

– “predicate”

• Biggest CDRH premarket program

– over 3000 submissions per year

FDA Guidance: Evaluation of Substantial Equivalence in a 510(k)

www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluatingsubstantial-equivalence-premarket-notifications-510k
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Predicate Device

• Preamendments

• Cleared through 510(k) process

• Reclassified from Class III to Class I or II

• Granted De Novo
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Substantial Equivalence (SE)

• Legally marketed predicate

• Same intended use

-AND-

• Same technological characteristics -OR-

• Different technological characteristics

– Does not raise different questions of safety and 

effectiveness

• Testing methods and data support SE
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Different Technological

Characteristics

• Significant change from predicate in:

– materials

– design

– energy source

– other features
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Product Codes

• FDA creates a three letter code

• Used to classify and track medical devices

• One classification regulation may have multiple 

product codes

– distinguish differences in technology or indications 

for use
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Product Codes

• Listed on 510(k) SE Letters

• Identify Third Party eligible device types

• Useful to identify predicate devices

• Required for various premarket and postmarket 

activities:

– device listing, importing and exporting
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Product Classification Database

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
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Example:

Non-Invasive Blood Pressure Device
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Product Code

Regulation Number

Consensus Standards

Third Party Eligibility
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510(k) Review Flowchart
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Identify the new 

device and the 

predicate device 

NSE

Decision 1

Is the

predicate device legally 

marketed?

Decision 3

Do the devices

have the same

technological

characteristics?

Decision 4

Do the different

technological characteristics

of the devices raise different

questions

of safety and 

effectiveness?

Decision 5a

Are the methods

acceptable?

Decision 5b

Do the data

demonstrate substantial

equivalence?

Review all labeling and 

assure

that it is consistent with IFU 

statements.

Review design, materials, 

energy source and other 

features of the devices.

Determine what questions 

of safety and effectiveness 

the different technological 

characteristics raise.

Review the proposed scientific

methods for evaluating new / 

different characteristics’ effects

on safety and effectiveness.

Evaluate performance 

data.

NSE

NSE NSE

NSE

SE SE

NO

YES

Decision 2

Do the devices

have the same

Intended use?

NO

YES

YES

NO

NO

NO

YES

NO

YES

Guidance: Evaluating Substantial 

Equivalence in Premarket 

Notifications

• Flowchart not intended to be 

used as a stand-alone 

document 

• Decision questions are 

answered in order

• Walk through with primary 

predicate
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Is Predicate Device Legally Marketed?

• Cleared 510(k)

• Granted De Novo

• Preamendments

• Reclassified from Class III 

to Class I or II

Identify the new 

device and the 

predicate device

Decision 1

Is the predicate 

device legally 

marketed?

Review all labeling and assure that 

it is consistent with IFU 

statements. 

YES

NSE NO
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Do devices have same intended use?

Intended Use

• general purpose of device or its function

• includes indications for use

Indications for Use (IFU)

• describes disease or condition the 

device will diagnose, treat, prevent, 

cure, or mitigate

• patient population
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Example 1: New Intended Use

and New Indications for Use

Blood Pressure Cuff

• Predicate IFU: Professional and home use to manually measure 

systolic and diastolic pressure

• Proposed IFU: Home use for automated diagnosis of heart 

attack or stroke

Different indications for use raise a safety and effectiveness issue 

not raised by predicate device new intended use 

General/Specific Intended Use-Guidance for Industry:

www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry
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Example 2: Same Intended Use

and New Indications for Use

Catheter

• Predicate IFU: Access femoral artery

• Proposed IFU: Access subclavian artery

• Intended use for both is to access an artery

• IFU only changes location of access

• No new risks or questions of safety or effectiveness
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Do devices have same

technological characteristics (TC)?

• Device description can inform if TC 

are comparable

• “Yes” implies descriptive 

characteristics enough for SE

• Uncommon to determine SE on 

descriptive characteristics alone

Decision 3

Do the devices have the 

same technological 

characteristics?

SE

YES

NO

Determine what 

questions of safety 

and effectiveness the 

different 

technological 

characteristics raise. 
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Do different TC raise different questions

of safety and effectiveness?

• Different Question

– Not applicable to predicate

– Poses unique safety or effectiveness 

concern for new device

• FDA responsible to identify 

different question

• If “Yes,” then Not Substantially 

Equivalent (NSE)

Decision 4

Do the different technological 

characteristics of the devices raise 

different questions of safety and 

effectiveness? 

NSE YES

Review the proposed scientific methods for 

evaluating new/ different characteristics’ 

effects on safety and effectiveness. 

NO
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Example 3: New TC and 

No Different Questions

Syringe: Change in plastic composition

• Change in material raises same questions

– biocompatibility

– material properties
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Example 4: New TC and 

Different Question

• Electrosurgical Device:

– Change energy from radiofrequency to ultrasound

– How is ultrasonic frequency controlled to avoid cavitation of cells?
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Are methods acceptable and 

do data demonstrate 

substantial equivalence?

• If no different questions of safety 

and effectiveness:

– can data evaluate differences?

• Are methods acceptable? (5a)

– Rare to answer “No”

• Review data (5b)
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After Device is Found

Substantially Equivalent

• Applicant receives SE letter

• FDA adds information to public FDA 510(k) 

Database

– Indications for Use form

– 510(k) Summary 

– SE Letter

– Decision summary (IVD products only)
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Summary

• 510(k) Program allows for a comparison of a new 

device to a predicate device to support that the 

new device is ‘as safe and effective’

• 510(k) flowchart supports 510(k) review with 

specific questions to aid in determining whether a 

device is or is not substantially equivalent
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1. Incorporate the basic principles of the 510(k) 

Program as you conduct your review

2. View other available resources on CDRH Learn

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