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Passcode: 7278970 
510(k) Third Party Review Program

J. Allen Hill

Physicist/Policy Analyst

Division of Program Operations and Management 

Office of In Vitro Diagnostics and Radiological Health

Office of Product Evaluation and Quality 

Center for Devices and Radiological Health

April 16, 2020
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• Objectives

• Background

• Eligibility Factors for Devices

• How 510(k) Third Party (3P510k) Review Organizations 

should review files

• Recognition and Rerecognition of 3P510k Review 

Organizations

• Suspension or Recognition Withdrawal

• Leveraging International Harmonization

Agenda

www.fda.gov
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Objectives

• Provide an overview of the 510(k) Third Party Review 

Program

• Identify eligible devices

• Recognize elements of an FDA-equivalent review

• Review key actions for 3P510k Review Organizations 

www.fda.gov
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Background

Delivers on 

MDUFA IV Commitment

Replaces 

Previous 3P510k Guidances

www.fda.gov
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The Review Organization Interacts 

with Submitters on the FDA’s Behalf

3P510k 

Review 

Organization

510(k) 

Submitter

www.fda.gov
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The Program Protects & 

Promotes Public Health

On higher risk & 

complex devices

Maintain 

Confidence

In safety & effectiveness 

of lower risk &

less complex devices

Enhance 

Speed to Market

With a voluntary 

alternative

review process 

Focus 

FDA Resources
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• Product code eligibility updated to support success

• 3P510k Review Organizations perform FDA-equivalent reviews

• 3P510k Review Organization recognition sunsets every 3 years

Program Updated to Eliminate Routine 

Re-Review

www.fda.gov
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Reviewing the Right Devices

No major

safety signals

Well- understood

Lower

risk

www.fda.gov See Section V of the guidance for more detail
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Reviewing the Right Devices cont.

Half of all 

510(k)s 

submitted to 

CDRH are 

eligible for 

3P510k 

review

Well- understood

Lower

risk

No major

safety signals

www.fda.gov See Section V of the guidance for more detail
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We Expect FDA-Equivalent Reviews

See Section VI of the guidance for more detail

Review, 

document & 

submit to the FDA

Ensure 

device is 

eligible 

Use relevant 

guidances & 

information

Assign

qualified 

reviewers

Interact 

Early with

the FDA

1 2 3 4 5

www.fda.gov
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• Review and assess the submission 

– How do you assess the regulatory question of 

substantial equivalence? 

– Assess ‘how’ rather than state that a standard or 

guidance was used

• Organize and submit to the FDA

– Be sure to include a useful Table of Contents

– Update the review memo to reflect deficiencies and 

their resolution 

FDA-Equivalent Reviews Explain their 

Analysis and Recommendation

See Section VI of the guidance for more detail

See “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantialequivalence-premarket-notifications-510k
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• Many disputes are often the results of misunderstanding or

miscommunication – seek clarification first 

• Center for Devices and Radiological Health Appeals 

Processes

• Center for Devices and Radiological Health Appeals 

Processes: Questions and Answers About 517A

• Complaints can be sent to 3P510k@fda.hhs.gov

3P510k Submitters and Review Organizations 

Have the Same Rights for Dispute Resolution

www.fda.gov
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Leveraging Global Standards

is Least Burdensome

Organizational Behaviors Good Regulatory Review Practices

MDSAP N3 GRRP N40

See Section X of the guidance for more detail

www.fda.gov Link to these documents on Resources Slide #21
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Main takeaway: 

– quality, well-documented, FDA-equivalent reviews

(A) Submissions, communications, and all documentation should 

be in English

(B) Impartiality, including not promising FDA clearance

- See also IMDRF N3

(C) Training and expertise of review personnel 

- Leverages IMDRF N40 

(D) Controls and records for using external technical expertise 

(E) Maintain confidentiality 

(F) Complaint handling 

(G) Recordkeeping

We Clarified Our Expectations of 

3P510k Review Organizations

See Section VII of the guidance for more detail www.fda.gov
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• The act provides exact language in 301(y)(1) for prohibited acts

• We expect 3P510k Review Organizations to demonstrate technical 

competency

• We will assess and audit 3P510k Review Organizations 

periodically as necessary

• If needed, we will suspend or withdraw recognition after providing 

notice and an opportunity for an informal hearing

We Clarified Suspension and Withdrawal of 

Recognition

See Section IX of the guidance for more detail www.fda.gov
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Follow Good Business Practices

Document 

& record

Be aware of 

prohibited acts

Maintain

quality reviews

See Section VII & IX of the guidance for more detail www.fda.gov
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• All entities will go through the new recognition process

• Work proactively on your recognition

• Submit your application as soon as practical

• All recognitions sunset after 3 years

Current 3P510k Review Organizations 

Should Submit Applications to be Recognized by 

September 12, 2020

www.fda.gov
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(1) Administrative Info, including device types

(2) Policies and procedures to prevent conflicts of interest

(3) Personnel qualifications

– Including supervisory personnel

(4) Certification statements

What You Should Include in Your Application 

to be a Recognized 510(k) Third Party Review Organization

See Section VIII of the guidance for more detail

Also available at FDA.gov

https://www.fda.gov/medical-devices/510k-third-party-review-program/how-become-third-party-review-organization

www.fda.gov
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The FDA Will Monitor & Audit

Feedback

Monitor Audit

3P510k 

Review 

Organization

12 to 18 

months

after 

recognition

Training

Review

Recognition
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• 510(k) Third Party Review Program: Final Guidance

– https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-reviewprogram

• 510(k) Third Party Review Program Webpage 

– https://www.fda.gov/medical-devices/premarket-submissions/510k-third-party-review-program

• CDRH Learn Modules for the 510(k) Third Party Review Program 

– https://www.fda.gov/training-and-continuing-education/cdrh-learn#collapseSeven

• Product Code Classification Database

– https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

• Federal Food, Drug, and Cosmetic Act

– https://legcounsel.house.gov/Comps/Federal Food, Drug, And Cosmetic Act.pdf

• IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): “Requirements for Medical Device Auditing 

Organizations for Regulatory Authority Recognition”

– http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf

• IMDRF/GRRP WG/N40 Final:2017: “Competence, Training, and Conduct Requirements for Regulatory 

Reviewers”

– http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf

Resources

www.fda.gov
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Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will 

be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: 510(k) Third Party Review Program 

www.fda.gov