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Special 510(k) Program

Angela DeMarco

510(k) Program Expert

Josh Silverstein

Regulatory Advisor

Office of Product Evaluation and Quality 

Center for Devices and Radiological Health

October 31, 2019
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This presentation will cover:

• Background on the Special 510(k) Program

• Results from the Special 510(k) Program Pilot

• Overview of the Special 510(k) Program

• Related 510(k) Program Updates

• Resources and Questions

Agenda
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Objectives

After this training, you should know:

• The results of the U.S. Food and Drug Administration’s (FDA) Special 510(k) Pilot

• How to determine if your submission is appropriate for the Special 510(k) Program

• What to submit and expect from the review process

• How the FDA updated other guidances to reflect the updated Special 510(k) 

Program, improved alignment between the related 510(k) guidances, and current 

policies

• How to find Resources
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1998

• The Special 510(k) Program was established in the FDA guidance “The New 510(k) Paradigm –

Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” 

(The New 510(k) Paradigm).

2018

• The FDA issued the draft guidance “The Special 510(k) Program.”

• The Special 510(k) Program Pilot launched.

2019

• The FDA issued the final guidances, “The Special 510(k) Program” and “The Abbreviated 510(k) 

Program,” to supersede the New 510(k) Paradigm guidance.

• The FDA withdrew the guidance “Frequently Asked Questions on the New 510(k) Paradigm”.

Special 510(k) Background
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The Special 510(k) Program

The Special 510(k) Program is an optional pathway for 

certain well-defined device modifications where a 

manufacturer modifies its own legally marketed device, and 

design control procedures produce reliable results that can 

form—in addition to other 510(k) content requirements—the 

basis for substantial equivalence.
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• The Pilot allowed the FDA and industry to test an expansion to the Special 

510(k) Program

• The goal of the Special 510(k) Program Pilot was to determine whether 

updated factors for the Special 510(k) Program would improve the efficiency 

of the FDA’s review of 510(k) submissions

• The FDA wanted to increase the number of 510(k) submissions that are 

appropriate for the Special 510(k) Program

• All Special 510(k)s received on or after October 1, 2018 were included in the 

Pilot. Our analysis reflects data from October 1, 2018 – July 1, 2019

Summary of Special 510(k) Program Pilot
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Pilot Assessment

• Number of Special 510(k) submissions received 

• The FDA Day it was placed on hold, if applicable

• Total time to decision

• If a submission was found not appropriate for a Special 510(k):

– The reason

– The FDA Day on which it was found not appropriate

– Total number of submissions that were converted from Special 510(k) to Traditional 510(k)

The FDA collected the following information:
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Pilot Data

Item Assessed Pilot 

(10/18-7/19)

Prior Year

(10/17-7/18)

Total number of Special 510(k)s received 476 464

Average Total Time to Decision of cleared files 43 days 49 days

Average FDA Day cleared file was placed on hold, if applicable 28 days 27 days

If converted to a Traditional 510(k): -- --

- Reason -- --

- Not manufacturer’s own device 5% 1%

- (pilot) Lack of well-established method 59% --

- (pre-pilot) Change in IFU -- 21%

- (pre-pilot) Change in technology -- 61%

- Cannot be placed into summary or risk-analysis format 23% 13%

- Other 13% 4%

- The average FDA days to conversion 15 days 16 days

- Conversion rate 25% 34%
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• Draft guidance issued on September 28, 2018

• 13 groups or individuals submitted approximately 130 comments

– Medical device manufacturers

– Trade associations

– Patient advocacy groups

– Consulting firm

Comments on the Draft Guidance
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Special 510(k) Factors

• Updated examples of well-established methods to include those found in FDA guidance and 

Medical Device Development Tools (MDDTs)

• Clarified that a Special 510(k) is not appropriate if change generally involves more than 3 

scientific disciplines

Examples

• Added new examples, including those for in vitro diagnostic devices

• Made minor changes to existing examples

Minor Policy Changes

• Clarified that the final guidance does not supersede other guidance document recommendations

• Recommended how to describe changes from predicate

• Clarified reprocessed single-use devices policy

• Referenced Bundling Policy for multiple unrelated changes

Changes Reflected in Final Guidance
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• Change(s) do not affect intended use; and

• Change(s) do not alter the fundamental scientific 

technology

The New 510(k) 

Paradigm 

(now superseded)

• Performance data are unnecessary, or if performance 

data are necessary, well-established methods are 

available to evaluate the change; and 

• All data necessary to support substantial equivalence 

can be reviewed in a summary or risk analysis format

The Special 510(k) 

Program 

(now final guidance)

Significant Changes to 

the Special 510(k) Program
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Special 510(k) Eligibility Factors 

The proposed change 

is made and 

submitted by the 

manufacturer 

authorized to market 

the existing device

Performance data 

are unnecessary, or if 

performance data 

are necessary, wellestablished methods 

are available to 

evaluate the change

All performance data 

necessary to support 

substantial 

equivalence can be 

reviewed in a 

summary or risk 

analysis format 

Appropriate for a 

Special 510(k) AND AND THEN
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• Special 510(k) relies on the FDA’s previous review of detailed 

information and existing design controls procedures

• The submitter should be the manufacturer legally authorized to 

market the predicate device

Special 510(k) Eligibility Factors 

A. Is it a change to the manufacturer’s own device?
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• If testing is not necessary, appropriate for a Special 510(k). If 

testing is necessary, proceed to the next Special 510(k) factor

• If there’s a disagreement about the need for performance data, 

the FDA intends to continue with the additional Special 510(k) 

factors

Special 510(k) Eligibility Factors 

B. Are performance data needed to evaluate the change?
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• Well established methods:

– The submitter’s methods, protocols, and acceptance criteria used to support the 

previously cleared 510(k) that can be applied to the subject 510(k)

– Methods in an FDA-recognized consensus standard or FDA guidance document

– Qualified medical device development tools (MDDTs) OR

– Widely available and accepted methods, or those found acceptable by the FDA in 

another marketing submission by the same submitter

• All methods used in 510(k) should be well-established

– If one does not exist, the FDA intends to convert to a Traditional 510(k)

• Submissions that use methods that rely on clinical studies or animal data are 

not typically appropriate for the Special 510(k) Program

Special 510(k) Eligibility Factors 

C. Is there a well-established method to evaluate the change?
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• Complete test reports should not be submitted in a Special 510(k)

• The FDA intends to assess whether information can be 

summarized, but will convert to Traditional 510(k) as necessary

• Data cannot be summarized when substantial equivalence 

determination depends on the FDA’s interpretation of the 

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

Small numbers of representative images can be submitted

Special 510(k) Eligibility Factors 

D. Can the data be reviewed in a summary or risk analysis format?
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• Changes that involve generally greater than three different scientific review 

disciplines

• Multiple devices with unrelated changes (see Bundling guidance)

• Common scenarios when a complete test report will be necessary to establish 

substantial equivalence

– clinical data

– novel sterilization methods

– certain Magnetic Resonance compatibility labeling changes

– when validation data should be provided (human factors, reprocessing)

– chemical characterization for biocompatibility

• When validation data is required for reprocessed single-use devices and reusable 

devices identified in Federal Register notices

Additional Considerations

E. When a Special 510(k) may not be appropriate:
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• The following recommended content apply when preparing Special 510(k) 

submissions, as noted in Appendix A of the guidance:

– A detailed description of changes

– A tabular comparison of the modified device to the cleared device

– Clean and redlined copies of documents that were updated since the predicate 

device’s submission (such as labeling, risk analysis)

– Tabular summary of design control activities, such as your risk analysis

– Based on the risk analysis, an identification of verification and validation activities, 

including a summary of test methods, acceptance criteria, and results, and why 

each is adequate to support substantial equivalence

– Indications for Use form (the FDA Form 3881)

– A signed statement on design controls activity

Preparing a Special 510(k)
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Change: Labeling change to environment of use for a transcutaneous electrical nerve stimulation (TENS) from a professional 

healthcare facility only to both professional healthcare facility and home use. The device is still intended to be used under the 

direction and supervision of a healthcare professional. 

• A - Is it a change to the manufacturer’s own device? Yes.

• B - Are performance data needed to evaluate the change? Yes. There are different acceptance criteria for electrical safety 

and electromagnetic compatibility (EMC) to address home use. 

• C - Is there a well-established method to evaluate the change? Yes. For example, the FDA-recognized standard methods 

ANSI/AAMI ES60601-1 35 and IEC 60601-2-1036 address basic safety and essential performance, IEC 60601-1-2 addresses 

EMC, and basic safety for home use devices (ANSI/AAMI HA60601-1-1138 or IEC 60601-1-1139), along with the CISPR 1140 

emission limits for Group 1 and Class B. The manufacturer provided their statement of essential performance and associated 

device-specific acceptance criteria. 

• D - Can the data be reviewed in a summary or risk analysis format? Yes. The particular standard used was identified. The 

acceptance criteria and results were summarized in a tabular format. A justification was provided for all results that were outside 

the bounds of an acceptance range or differed from the predicate. The results can be summarized because the substantial 

equivalence determination does not depend on the Agency’s interpretation of the underlying data, such as images, raw graphs, 

or line item data. 

Decision: Change can be reviewed in a Special 510(k).

Example 1 – Appropriate for a Special 510(k)
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Change: Modify the general indications for delivering illumination and laser energy for photocoagulation to include specific clinical

applications for treatment of retinopathy. 

• A - Is it a change to the manufacturer’s own device? Yes.

• B - Are performance data needed to evaluate the change? Yes. Clinical testing is typically provided to support marketing 

clearance for such a change in the indications for use. The requested change in the indications for use now identify a specific 

disease condition. The clinical outputs have changed from general coagulation of blood vessels to treatment of retinopathy. 

Clinical testing should be conducted to assess new outcomes such as decrease in vision impairment, whereas the predicate 

assessed the general outcome of successful vessel coagulation. 

• C - Is there a well-established method to evaluate the change? No. There is no well-established method identified in the 

predicate’s submission or a consensus standard to evaluate clinical endpoints for this device. The substantial equivalence

determination rests on a review of the underlying clinical performance data. 

• D - Can the data be reviewed in a summary or risk analysis format? N/A. 

Decision: Change cannot be reviewed in a Special 510(k).

Example 2 – Not appropriate for a Special 510(k)
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Change: Change the labeling of a blade-form endosseous dental implant from “Safety in MRI Not Evaluated” to “MR Conditional.” 

• A - Is it a change to the manufacturer’s own device? Yes, the submitter is the manufacturer of the predicate device. 

• B - Are performance data needed to evaluate the change? Yes. Non-clinical performance testing to support substantial 

equivalence should be provided by manufacturers seeking MR Conditional labeling for a device that contains metallic 

components. The FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic 

Resonance (MR) Environment provides recommendations for such testing. 

• C - Is there a well-established method to evaluate the change? Yes. There are FDA-recognized voluntary consensus 

standards such as ASTM F2503, 58 ASTM F2052, 59 ASTM F2213, 60 ASTM F2182, 61 and ASTM F211962 for MR 

compatibility testing of passive implants. 

• D - Can the data be reviewed in a summary or risk analysis format? No. Although there are consensus standards for all 

test methods, FDA does not believe this data can be summarized because the SE determination will depend on FDA’s 

interpretation of the underlying data to support the MR Conditional label. This includes interpretation of device-specific 

pass/fail criteria and results that are not addressed in the standard.

Decision: Change cannot be reviewed in a Special 510(k).

Example 3 – Not appropriate for a Special 510(k)
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• Recommended content as noted in Appendix C of the guidance:

– Device change

– Risks associated with the device change

– Verification/Validation (V&V) method(s) used to evaluate the change

– Acceptance criteria

– Deviations to the V&V method(s) and/or acceptance criteria with justifications

– Summary of results

• Description rather than just stating pass/fail for non-binary tests

• If leveraging results from another study or test, or citing a risk analysis, 

include a justification for why this is acceptable

Example of Summary of Design Control Activities
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• Subject to the Refuse to Accept Policy for 510(k)s, the FDA generally reviews 

Special 510(k)s within 30 days of receipt

• If a Special 510(k) is found to be inappropriate for review in this program, the 

FDA intends to convert to a Traditional 510(k). If converted:

– Management concurrence occurs prior to conversion

– The FDA intends to explain the reasons for conversion using the Special 

510(k) factors

– This may delay the review process because the FDA will likely request 

complete test reports

What to Expect During Special 510(k) Review
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• Reflects the updated Special 510(k) Program, improve alignment 

between the related 510(k) guidances, and reflect current policies

Related Guidance Updates: Refuse to Accept Policy for 

510(k)s 
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• The recommended format of a Traditional and Abbreviated 510(k) 

now aligns with the order of the Refuse to Accept (RTA) Checklist

• Contemporary guidance and website links

• These updates are not intended to reflect new policy

Other Guidance Update: Format for Traditional and 

Abbreviated Premarket Notifications
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• The Special 510(k) Program guidance was operationalized upon issuance of the final 

guidance (September 13, 2019)

• We recognize that both the FDA and industry may need up to 60 days to 

operationalize changes to the guidance Refuse to Accept Policy for 510(k)s. If a 

510(k) is received by the FDA before or up to 60 days after the publication of this 

guidance and does not include all criteria necessary to meet a minimum threshold of 

acceptability, the FDA may decide not to refuse to accept.

• Until November 13, 2019, once FDA has determined a submission is appropriate for 

review as a Special 510(k) as described in the Special 510(k) Program guidance, 

and for all other 510(k) submission types, FDA intends to utilize the prior final RTA 

guidance to assess whether a 510(k) submission meets a minimum threshold of 

acceptability and should be accepted for substantive review. 

Stakeholder Considerations
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• The Special 510(k) Program

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special510k-program

• The Abbreviated 510(k) Program

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/abbreviated-510k-program

• Format for Traditional and Abbreviated 510(k)s

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formattraditional-and-abbreviated-510ks

• Refuse to Accept Policy for 510(k)s

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuseaccept-policy-510ks

Resources
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Questions?

Division of Industry and Consumer Education: DICE@fda.hhs.gov

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