The 510(k) Program

November 4, 2014

LCDR Kimberly Piermatteo, MHA

Regulatory Operations Officer

Center for Devices and Radiological Health

U.S. Food and Drug Administration
A Premarket Notification [510(k)] 

is one of the major pathways for 

bringing a device to market. 

2
Learning Objectives

1. To understand medical device classifications and how classifications 

apply to 510(k)s

2. To understand what a 510(k) is, when it is required and the different 

types of 510(k) submissions 

3. To understand the content of a 510(k) and what should be submitted to 

the FDA 

4. To understand the 510(k) submission process including how and when 

the FDA will communicate with submitters regarding their 510(k) 

5. To understand 510(k) decisions and what they mean 

3
Presentation Outline

• Device Classification As It Relates to 510(k)s

• Overview of 510(k) Program

• Content of a 510(k)

• 510(k) Submission Process

• 510(k) Decisions

4
Medical Device Classifications

• Class I = Low Risk Devices

– Subject to general controls

– Most, but not all, class I devices are exempt from premarket notification [510(k)]

• Class II = Moderate Risk Devices

– Subject to general and special controls 

– Most, but not all, Class II devices require a premarket notification [510(k)]

• Class III = High Risk Devices

– Subject to general controls and premarket approval 

5
Product Codes

• Three letter codes

• Used by FDA to identify and track similar medical 

devices

• Used by 510(k) submitters to search for a 

predicate device(s)

• Found on most 510(k) clearance letters

6
References

• Guidance – Medical Device Classification Product Codes: 

http://www.fda.gov/medicaldevices/deviceregulationandguid

ance/guidancedocuments/ucm285317.htm

• Product Classification Database: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/cl

assification.cfm

7
Example: Product Classification Database

8
What do you do if you cannot 

determine the appropriate device 

classification?

513(g) Program

9
• There is a 513(g) User Fee. 

• FDA responses to requests for information about the 

regulatory requirements applicable to a particular 

device DO NOT constitute FDA clearance or 

approval for distribution of that particular device in 

the U.S.

10

513(g) Program Reminders
References

• Guidance – FDA and Industry Procedures for Section 

513(g) Requests for Information under the Federal Food, 

Drug, and Cosmetic Act: 

http://www.fda.gov/medicaldevices/deviceregulationandguid

ance/guidancedocuments/ucm209841.htm

• Guidance – User Fees for 513(g) Requests for Information: 

http://www.fda.gov/medicaldevices/deviceregulationandguid

ance/guidancedocuments/ucm209852.htm

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Presentation Outline

• Device Classification As It Relates to 510(k)s

• Overview of 510(k) Program

• Content of a 510(k)

• 510(k) Submission Process

• 510(k) Decisions

12
A 510(k) is: • A Premarket Notification 

• Section 510(k) of Federal FD&C Act 

• 21 CFR 807 Subpart E 

• It is a marketing clearance application

• 510(k)s are “cleared”

• Allows FDA to determine Substantial Equivalence

• A Form

• Establishment Registration

• Device Listing

• Premarket Approval (PMA)

13

A 510(k) is not: 
What is Substantial Equivalence (SE)?

• Demonstration that a new device, as compared to a 

predicate device, has...

– the same intended use and

– the same technological characteristics, 

• Or differences in technological characteristics do not 

raise different questions regarding safety and 

effectiveness.

14
What is a Predicate Device?

• A legally marketed device, previously cleared 

through the 510(k) process mainly, that is used 

for comparison to a new device for the purpose 

of determining substantial equivalence (21 

CFR 807.92(a)(3)). 

15
References

• Premarket Notification (510k): 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice

/PremarketSubmissions/PremarketNotification510k/default.htm

• Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket 

Notifications [510(k)]: 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/UCM284443.pdf

• CDRH Learn Webinar “The 510(k) Program Guidance: Evaluating Substantial Equivalence 

in Premarket Notifications” [8/15/2014] (Under the Header “How to Market Your Device): 

http://www.fda.gov/Training/CDRHLearn/default.htm

• How to Find and Effectively Use Predicate Devices: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/pr

emarketsubmissions/premarketnotification510k/ucm134571.htm

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17

510(k) 

Decision-

Making Flow 

Chart 
Establishing Substantial Equivalence

Decision Points From Flowchart

1. Is the predicate device legally marketed?

2. Do the devices have the same intended use?

3. Do the devices have the same technological characteristics?

4. Do the different technological characteristics of the devices raise 

different questions of safety and effectiveness?

5. Two Parts:

a) Are the methods acceptable?

b) Do the data demonstrate substantial equivalence?

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When is a 510(k) Typically Required?

• Introducing a device to the market for the first 

time

• Changing the indications for use of a previously 

cleared device

• Making significant modification(s) to a previously 

cleared device

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References

• Is a new 510(k) required for a modification to the device?: 

http://www.fda.gov/medicaldevices/deviceregulationandguida

nce/howtomarketyourdevice/premarketsubmissions/premarke

tnotification510k/ucm134575.htm

• Guidance - Deciding When to Submit a 510(k) for a Change 

to an Existing Device (K97-1): 

http://www.fda.gov/medicaldevices/deviceregulationandguida

nce/guidancedocuments/ucm080235.htm

20
Types of 510(k) Submissions

Traditional 510(k)

Abbreviated 510(k)

Special 510(k)

21
Traditional 510(k)

• Required elements (21 CFR 807.87)

• Relies on the demonstration of substantial 

equivalence 

• The Traditional 510(k) method can be used 

under any circumstance. The Abbreviated 510(k) 

and Special 510(k) methods can only be used if 

certain criteria are met. 

22
Abbreviated 510(k)

• Required elements (21 CFR 807.87)

• Relies on the use of guidance documents, special 

controls, and recognized standards 

• Under certain conditions, sponsors may not need to 

submit test data in an Abbreviated 510(k).

23
Special 510(k)

• Required elements (21 CFR 807.87)

• Device modification to manufacturer’s own legally 

marketed device

• Modification does NOT affect the intended use or 

fundamental scientific technology

• No data is evaluated by FDA 

24
References

• How to Prepare a Traditional 510(k): 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmi

ssions/premarketnotification510k/ucm134572.htm

• How to Prepare An Abbreviated 510(k): 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmi

ssions/premarketnotification510k/ucm134574.htm

• How to Prepare A Special 510(k): 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmi

ssions/premarketnotification510k/ucm134573.htm

• 510(k) Screening Checklist: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSu

bmissions/PremarketNotification510k/ucm071360.htm

• 510(k) Forms: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSu

bmissions/PremarketNotification510k/ucm070202.htm

25
What do you do if...

Consider de novo

26

You have a low or moderate risk device with 

no identifiable predicate device?
Presentation Outline

• Device Classification As It Relates to 510(k)s

• Overview of 510(k) Program

• Content of a 510(k)

• 510(k) Submission Process

• 510(k) Decisions

27
Content of a 510(k)

• Medical Device User Fee Cover Sheet 

(Form FDA 3601)

• CDRH Premarket Review Submission 

Cover Sheet

• 510(k) Cover Letter

• Indications for Use Statement

• 510(k) Summary or 510(k) Statement

• Truthful and Accuracy Statement

• Class III Summary and Certification

• Financial Certification or Disclosure 

Statement

• Declarations of Conformity and 

Guidance Documents

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• Executive Summary

• Device Description

• Substantial Equivalence Discussion

• Proposed Labeling

• Sterilization and Shelf Life

• Biocompatibility

• Software

• Electromagnetic Compatibility and 

Electrical Safety

• Performance Testing – Bench

• Performance Testing – Animal

• Performance Testing – Clinical

• Other
Intended Use and Indications for Use

• Intended Use: General purpose of the device or its function, and 

encompasses the indications for use 

– Indications for Use: As defined in 21 CFR 814.20(b)(3)(i), describes 

the disease or condition the device will diagnose, treat, prevent, cure, 

or mitigate, including a description of the patient population for which 

the device is intended.

• Must be consistent throughout your 510(k), including the indications for 

use statement, proposed labeling, etc. 

• Recommended Format for Indications for Use Statement (Form FDA 

3881)

– Identify prescription use and/or over-the-counter use

29
510(k) Summary

• High level discussion of the content within the 510(k) 

• Must include elements in 21 CFR 807.92 

• Must include sufficient detail to provide an understanding of 

the basis for a determination of substantial equivalence

• FDA will verify the accuracy and completeness of the 510(k) 

Summary information during the 510(k) review

• Guidance – The 510(k) Program: Evaluating Substantial Equivalence in 

Premarket Notifications [510(k)], Appendix B. The 510(k) Summary 

Document Requirements

30
FDA Recognized Consensus Standards

(Declarations of Conformity)

• Voluntary program 

• Used to simplify and streamline the 510(k) review process

• Sponsors can only declare conformance to FDA recognized 

consensus standards

• Must document extent of conformance in 510(k) application 

(Form FDA 3654 - Standards Data Report for 510(k)s)

31
References

• Guidance – Recognition and Use of Consensus Standards: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocume

nts/ucm077274.htm

• Guidance - Frequently Asked Questions on Recognition of Consensus Standards: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocume

nts/ucm074973.htm

• Recognized Consensus Standards Database: 

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

• Standards Data Form (Form FDA 3654): 

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM0816

67.pdf

32
FDA Guidance Documents

• Represents FDA's current thinking on a topic

• May be device specific or general 

• Does not create or confer any rights for or on any person and does not 

operate to bind FDA or the public

• Alternative approaches may be used if the approach satisfies the 

requirements of the applicable statutes and regulations

• FDA Guidance Document Database: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guid

anceDocuments/default.htm

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Example: Product Classification Database

34
Device Description

• Within a 510(k) the device description should 

include: 

– Overall description of the device design (e.g. physical 

specifications, dimensions, design tolerances, engineering 

drawings, figures, etc.)

– Materials (e.g. list all patient contacting components)

– Energy sources 

– Other key technological features 

35
Substantial Equivalence Discussion

• Substantial Equivalence is defined in section 513(i) of the FD&C 

Act 

• Utilize 510(k) Decision-Making Flowchart

• 510(k) review standard is comparative (i.e. new device compared 

to predicate device)

– Multiple predicate devices are ok under certain circumstances 

– Split predicates are inconsistent with 510(k) regulatory standard 

– Reference devices may be used to support scientific methodology or 

standard reference values. Reference devices are not predicate 

devices 

36
Labeling

• Comply with Device Labeling Requirements (21 CFR 801)

• Copies of all proposed labels, labeling, package inserts, service manuals, 

instructions for use, advertising and/or promotional materials 

• The directions for use should include a specific intended use statement 

and any warnings, contraindications, or limitations

• Labeling submitted should be final draft

• Copies of labeling for the predicate device is recommended

• Introduction to Medical Device Labeling: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/overvie

w/devicelabeling/default.htm

37
Performance Testing

• Bench, Animal, or Clinical

• Necessary performance tests depend on the complexity of 

the device and its intended use and indications

• Consider FDA Guidance Documents 

• Consider comparative testing to demonstrate substantial 

equivalence 

• Include: test methods, acceptance criteria and test results for 

review

38
Performance Testing - Clinical

• Not all 510(k)s require clinical data. 

• Clinical data may be requested in the following situations:

1. New or Modified Indications for Use – Same Intended 

Use

2. Significant Technological Differences

3. Non-clinical Testing Methods are Limited or 

Inappropriate Because of the Indications for Use or 

Device Technology

39
Key Considerations

• Information is complete and organized

– Include a table of contents

– Use tabs and paginate properly

– Utilize tables and graphs appropriately and effectively

– Use visual aids whenever possible

• Clearly identify basic 510(k) requirements (e.g. 510(k) Summary, 

Indications for Use Form, etc.)

• Be consistent throughout the submission

• Follow current applicable guidance documents and device specific 

checklists

40
References

• Content of a 510(k): 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid

ance/HowtoMarketYourDevice/PremarketSubmissions/Prema

rketNotification510k/ucm142651.htm

• 510(k) Format Tips: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid

ance/HowtoMarketYourDevice/PremarketSubmissions/Prema

rketNotification510k/ucm142648.htm

41
Pre-Sub for a 510(k) 

• Guidance: Requests for Feedback on Medical Device 

Submissions: The Pre-Submission Program and Meetings with 

Food and Drug Administration Staff

• Method to obtain FDA feedback prior to submission of your 

510(k); typically for unique situations (e.g. need for clinical data)

• Submit a formal written request to the FDA

• Request either a formal written response, meeting, or 

teleconference to address their concerns, questions, etc. 

• Subject to eCopy requirements

42
References

• Guidance – Requests for Feedback on Medical Device 

Submissions: The Pre-Submission Program and Meetings 

with Food and Drug Administration Staff: 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulat

ionandGuidance/GuidanceDocuments/UCM311176.pdf

• CDRH Learn Webinar – Pre-Submissions and Meetings with 

FDA Staff [2/28/2014]: 

http://www.fda.gov/Training/CDRHLearn/default.htm

43
Presentation Outline

• Device Classification As It Relates to 510(k)s

• Overview of 510(k) Program

• Content of a 510(k)

• 510(k) Submission Process

• 510(k) Decisions

44
Submission to FDA

• You must submit two copies of your 510(k)

• One of your two copies must be submitted in an electronic format (i.e. eCopy) 

• FDA does NOT return the 510(k) submission after review 

• Where do you mail your 510(k)?

Food and Drug Administration 

Center for Devices and Radiological Health

Document Control Center (DCC) - WO66-G609

10903 New Hampshire Avenue

Silver Spring, Maryland 20993-0002

• Addresses for Submissions: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyou

rdevice/premarketsubmissions/ucm135103.htm

45
eCopy Program

• Valid eCopy is a requirement for Premarket Submissions 

• An eCopy is defined as an exact duplicate of the paper submission, 

created and submitted on a compact disc (CD), digital video disc (DVD), 

or a flash drive 

• An eCopy is accompanied by a paper copy of the signed cover letter and 

the complete paper submission

• Questions regarding eCopy requirements or responses to eCopy holds 

should be sent to CDRH-eCopyinfo@fda.hhs.gov

• eCopy Program for Medical Device Submissions: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtom

arketyourdevice/ucm370879.htm

46
510(k) User Fees 

• 510(k) Submissions are subject to user fees.

• User Fees must be received on or before the time 

the application is submitted. 

• FDA will not accept the 510(k) for filing if the fee is 

not paid. 

• There is a standard user fee and a small business 

reduced user fee. 

47
References

• Premarket Notification [510(k)] Review Fees: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyo

urdevice/premarketsubmissions/premarketnotification510k/ucm134566.htm

• Guidance for Industry and Food and Drug Administration Staff - User Fees and 

Refunds for Premarket Notification Submissions (510(k)s): 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo

cuments/ucm345277.htm

• Guidance – FY2015 Medical Device User Fee Small Business Qualification and 

Certification: 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/O

verview/MDUFAIII/UCM314389.pdf

48
510(k) Submission 

Process

49

Important Notes:

• Days are Calendar Days 

• The timeline is based on the 

MDUFA III Performance Goals 

• This timeline has been 

simplified 
References

• 510(k) Submission Process: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyo

urdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

• Guidance – Types of Communication During the Review of Medical Device 

Submissions - Guidance for Industry and Food and Drug Administration Staff: 

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocum

ents/ucm341918.htm

• Guidance - FDA and Industry Actions on Premarket Notification (510(k)) 

Submissions: Effect on FDA Review Clock and Goals: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/ucm089735.htm

50
510(k) Submission Process

51
510(k) Submission Process

52
Refuse to Accept (RTA) Policy 

• Guidance – Refuse to Accept Policy for 510(k)s: 

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguida

nce/guidancedocuments/ucm315014.pdf

• Is the 510(k) submission administratively complete for substantive 

review?

• Early Review – 15 calendar days from receipt

• Necessary elements and content of a complete 510(k) submission

• FDA clock begins on the date of receipt when the 510(k) is “accepted for 

review”

53
510(k) Submission Process

54
Substantive Interaction

FDA Notification that:

1. The 510(k) will not be placed on hold and 

outstanding deficiencies will be resolved via 

Interactive Review, or

2. The 510(k) is being placed on hold via an 

Additional Information request which identifies 

the outstanding deficiencies that need to be 

addressed before substantive review can continue. 

55
Interactive Review

• Informal interaction between FDA and submitters during the review 

of 510(k) submissions

• Benefits: Prevent unnecessary delays; Reduce the overall time to 

decision; Ensure that FDA’s concerns are clearly communicated; 

Minimize the number of review cycles; and Ensure timely responses 

from submitters

• Interactive review requests do not stop the FDA clock

• *NOTE*: Interactive Review correspondence is not subject to eCopy 

requirements unless submitted through the Document Control 

Center (DCC)

56
Additional Information (AI) Requests

• Why is additional information requested?

– Testing data required to demonstrate equivalence

– Reviewer has questions regarding labeling, wording, etc. 

• How is additional information requested?

– AI requests are sent via email

– AI responses are subject to eCopy requirements 

• How does this affect the submission review times?

– Clock stops when submission is officially placed on hold

– 180 days for a complete response to be received to DCC

57
510(k) Submission Process

58
MDUFA III Performance Goals

59

510(k) Submission 

Type

FDA Review Days

Traditional and 

Abbreviated 90

Special 30

• MDUFA III Performance Goals: 

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/Work

shopsConferences/UCM295454.pdf
510(k) Submission Process

60
Presentation Outline

• Device Classification As It Relates to 510(k)s

• Overview of 510(k) Program

• Content of a 510(k)

• 510(k) Submission Process

• 510(k) Decisions

61
510(k) Decisions

NSE Decision

Resubmit another 510(k) with 

new data, PMA, de novo or 

reclassification petition

SE Decision

Device To Market

62
Why might you receive a NSE Decision?

1. There is no predicate device

2. Your device has a NEW intended use

3. Your device has different technological characteristics 

compared to the predicate device and raises different 

questions regarding safety and effectiveness

4. You did not demonstrate that your device is at least as 

safe and effective as the predicate 

63
What Happens After a Device is Cleared?

• The following are posted on the FDA’s public 510(k) database:

– SE Letter

– Indications for Use Form

– 510(k) Summary (if provided instead of 510(k) Statement) 

*NOTE: For 510(k) Statements, submitters must make available all 

information included in this premarket notification on safety and 

effectiveness within 30 days of request by any person (21 CFR 

807.93).

64
Summary

1. The appropriate classification for a device will indicate whether or not 

510(k) clearance is required before the device can be legally marketed.

2. The 510(k) review standard is comparative i.e. substantial equivalence 

must be demonstrated for a new device compared to a legally marketed 

predicate device. 

3. A 510(k) should contain all the content necessary to demonstrate the 

safety and effectiveness of the new device compared to the predicate 

device. 

4. FDA will communicate with submitters during the review of their 510(k)s 

based on specified performance goals. 

5. A 510(k) which is found substantially equivalent can then be legally 

marketed in the U.S. 

65
Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

§ over 80 modules - videos, audio recordings, power point presentations, software-based 

“how to” modules

§ accessible on your portable devices: http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education

§ comprehensive regulatory information on premarket and postmarket topics:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE)

§ If you have a question - Email: DICE@fda.hhs.gov

§ Phone: 1(800) 638-2014 or (301) 796-7100 (Live Agents 9am – 4:30 pm EST)

§ Web Homepage: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs--

DivisionofIndustryandConsumerEducation/default.htm

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Thank You

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