Contains Nonbinding Recommendations 
 
510(k) Third Party Review Program 
Guidance for Industry, 
Food and Drug Administration Staff, 
and Third Party 
Review Organizations 
 
 
Document issued on March 12, 2020 
 
The draft of this document was issued on September 14, 2018 
 
 
 
This guidance supersedes Implementation of Third Party Programs Under 
the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and 
Third Parties issued on February 2, 2001, and Guidance for Third Parties 
and FDA Staff; Third Party Review of Premarket Notifications issued on 
September 28, 2004. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
 
 
OMB Control No. 0910-0375 
Current expiration date available at https://www.reginfo.gov 
See additional PRA statement in Section XI of this guidance 
 
 
 
 
 
 
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  Contains Nonbinding Recommendations 
 
 
 
Preface 
 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov . Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2016-D-2565. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 1500013 and complete title of the guidance in the request. 
 
 
 
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Table of Contents
 
 
I.  Introduction ....................................................................................................................... 4 
II.  Background ....................................................................................................................... 5 
  Basis for 3P510k Review Program ........................................................................................................... 5 
  General Overview of 3P510k Review Program ....................................................................................... 6 
III.  Scope................................................................................................................................... 7 
IV.  Definitions .......................................................................................................................... 8 
V.  Factors Used in Determining Device Type Eligibility in the 3P510k Review Program10 
VI.  Review of 510(k) Submissions by 3P510k Review Organizations .............................. 12 
  Determine device eligibility for 3P510k review ......................................................................................13 
  Assign a Product Specialist(s) and Technical Expert(s) to   conduct the substantive review of a 510(k) 
submission ...........................................................................................................................................14 
  Obtain relevant FDA guidance(s) and information .................................................................................14 
  Early Interaction with FDA (as needed) ..................................................................................................16 
  Ensure a submission is administratively complete ..................................................................................16 
  Conduct the substantive review of a 510(k) submission .........................................................................17 
  Identify deficiencies in a 510(k) submission ...........................................................................................18 
  Document a 510(k) review ......................................................................................................................19 
  Organize and submit a 510(k) submission including    associated 3P510k review documentation .........20 
  Submit additional information upon FDAs request ................................................................................22 
  510(k) submission dispute resolution ......................................................................................................23 
VII. Requirements and Recommendations for Recognition and Rerecognition of Third Party 
Review Organizations ..................................................................................................... 24 
  Operational considerations ......................................................................................................................25 
  Management of impartiality ....................................................................................................................25 
  Personnel involved in reviewing activities ..............................................................................................26 
  Use of external Technical Experts ...........................................................................................................28 
  Confidential information .........................................................................................................................28 
  Complaints regarding 510(k) Submitters .................................................................................................29 
  Third Party Review Organization recordkeeping ....................................................................................29 
VIII. Content and Format of an Application for Initial Recognition and Rerecognition as a 
3P510k Review Organization ......................................................................................... 30 
  Initial Recognition ...................................................................................................................................31 
(1)  Administrative information .............................................................................................................31 
(2)  Prevention of conflicts of interest ...................................................................................................33 
(3)  Personnel qualifications .................................................................................................................33 
(4)  Certification statements ..................................................................................................................34 
  Rerecognition ..........................................................................................................................................35 
  Recognition or Rerecognition Denial ......................................................................................................35 
IX.  Suspension or Recognition Withdrawal........................................................................ 36 
X.  Leveraging the International Medical Device Regulators Forums (IMDRFs) 
documents ........................................................................................................................ 37 
XI.  Paperwork Reduction Act of 1995................................................................................. 38 
 
 
 
 
 
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510(k) Third Party Review Program 
Guidance for Industry,  
Food and Drug Administration Staff, 
and Third Party Review Organizations 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
 
The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons 
(AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) 
Act.1 Under this authority, FDA recognizes third parties to review premarket notification 
(510(k)) submissions and recommend the initial classification of certain devices.  FDAs 
implementation of section 523 establishes a process for recognition of qualified third parties to 
conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible 
for review under the 3P510k Review Program within the Center for Devices and Radiological 
Health (CDRH).2  This guidance document also reflects amendments made to section 523 by the 
FDA Reauthorization Act of 2017 (FDARA),3 which directed FDA to issue guidance4 on the 
factors that will be used in determining whether a class I or class II device type, or subset of such 
device types, is eligible for review by an accredited person.  
 
For the current edition of the FDA-recognized standards referenced in this document, see the 
FDA Recognized Consensus Standards Database.5  For more information regarding use of 
consensus standards in regulatory submissions, please refer to FDA guidance entitled, 
 
1 Section 523 of the FD&C Act uses the terms accredited persons, accredit, accredited, accreditation, 
reaccredit, reaccredited, and reaccreditation. The guidance does not use those statutory terms but rather 
defines such terms as recognition, and rerecognition as synonymous terms. These alternative terms are used in 
this guidance to harmonize the terms used by FDA and in the FD&C Act with those in the International Medical 
Device Regulators Forum (IMDRF)  Medical Device Single Audit Program (MDSAP) documents and are defined in 
Section IV of this guidance.   
2 Currently, the Center for Biologics Evaluation and Research does not regulate devices of the types subject to this 
guidance. 
3 Pub. L. 115-52 
4 See section 523(a)(3)(B) of the FD&C Act. 
5 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
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Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.6 
 
The objectives of this guidance are:  
 
1.  To describe the factors FDA will use in determining device type eligibility for review by 
3P510k Review Organizations 
2.  To outline FDAs process for the recognition, rerecognition, suspension, and withdrawal 
of recognition for 3P510k Review Organizations  
3.  To ensure consistent quality of work among 3P510k Review Organizations through the 
Medical Device User Fee Amendments (MDUFA) IV commitments authorized under 
FDARA7 to eliminate the need for routine, substantive re-review by FDA.8  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required.  
II.  Background 
  Basis for 3P510k Review Program 
 
On August 1, 1996, FDA launched a voluntary third party 510(k) review pilot program for 
selected medical devices. Under this pilot program, all class I devices that were not 510(k) 
exempt at that time, and 30 class II devices were eligible for 3P510k review.  
 
On November 21, 1997, the Food and Drug Administration Modernization Act (FDAMA) was 
signed into law. Section 210 of FDAMA9 codified and expanded the pilot program by 
establishing section 523 of the FD&C Act.  
 
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA)10 was 
signed into law and required FDA to establish and publish criteria to accredit, reaccredit, and 
deny reaccreditation of 3P510k Review Organizations that perform 510(k) reviews of eligible 
devices.     
 
On August 18, 2017, FDARA11 was signed into law and required FDA to issue guidance on the 
factors FDA will use in determining whether a class I or class II device type, or subset of such 
 
6 See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices. 
7 Pub L. 115-52 
8 See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews.  Available at 
https://www.fda.gov/media/116168/download. 
9 Pub. L. 105-115 
10 Pub. L. 112-144 
11 Pub. L. 115-52 
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device types, is eligible for review by 3P510k Review Organizations, including the risk of the 
device type and whether the device type is permanently implantable, life sustaining, or life 
supporting, and whether there is a detailed public health justification for permitting the review by 
an accredited person of such device type.  This guidance also addresses several MDUFA IV 
commitments by including an early interaction consult policy and clarifying criteria for 
rerecognition of 3P510k Review Organizations and the suspension or withdrawal of 
recognition.12   
 
  General Overview of 3P510k Review Program 
 
The 3P510k Review Program is intended to support CDRHs mission to protect and promote 
public health by enabling FDA to focus its internal scientific review resources on higher-risk and 
complex devices, while maintaining a high degree of confidence in the review of low-to-
moderate risk and less complex devices by 3P510k Review Organizations, and to provide 
manufacturers of eligible devices a voluntary alternative review process that may yield more 
rapid decisions on 510(k)s. See section 523(a)(3) of the FD&C Act. Figure 1 below provides a 
schematic overview of the 3P510k Review Program.13 
 
Figure 1  A General Overview of the 3P510k Review Program 
 
510(k) Submitter 
sends submission to  Submission 
3P510k Review  review is 
Organization 3P510k Review  3OP5rg1a0nki Rzaetvioienw   FDA reviews  FDA informs  3OP5rg1a0nki Rzaetvioienw   complete
Organization  submits  recommendation  3P510k Review  informs 510(k) 
reviews  recommendation &  and makes final  Organization of  Submitter of final 
submission documentation to  decision final decision End
decision
FDA  
 
Under the 3P510k Review Program, 3P510k Review Organizations review a 510(k) submission 
and then forward their review, the 510(k) submission, and a recommendation (e.g., substantially 
equivalent (SE) or not substantially equivalent (NSE)) to FDA. FDA reviews the 3P510k Review 
Organizations memo and recommendation and makes a final decision on the submission. 
Section 523(a)(2) of the FD&C Act requires FDA to make a determination with respect to the 
initial classification within 30 calendar days14 after receiving a recommendation from a 3P510k 
Review Organization. The 510(k) Submitter pays the 3P510k Review Organization directly; no 
user fee is due to FDA for the 510(k) reviewed by the 3P510k Review Organization.15  A general 
principle of the 3P510k Review Program is that the 3P510k Review Organization is the conduit 
for communication to and from the 510(k) Submitter and to and from the FDA.  This ensures the 
 
12 Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of 
eliminating routine re-review by FDA of 3P510k reviews: See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 
2017) (Food and Drug Administration User Fee Reauthorization), also available at 
https://www.fda.gov/media/102699/download.  
13 Figure 1 uses IEC/IEC 19510: Information technology  Object Management Group Business Process Model and 
Notation (2013).  
14 FDA uses calendar days when measuring on-time performance of user-fee supported premarket medical device 
submission reviews. See, MDUFA Performance Goals and Procedures, Fiscal Years 2018 through 2022 at 
https://www.fda.gov/media/102699/download for more information.  
15 See Section 738(a)(2)(B) of the FD&C Act. 
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3P510k Review Organization is fully informed and that communications do not undermine their 
role.   
 
A 3P510k Review Organization must be recognized by FDA under section 523(b) of the FD&C 
Act to be eligible to participate in the 3P510k Review Program. FDA recognizes 3P510k Review 
Organizations16 to review 510(k)s for certain device types eligible for the 3P510k Review 
Program.17   
   
Participation by 510(k) Submitters in the 3P510k Review Program is entirely voluntary.  
Manufacturers who do not wish to use a 3P510k Review Organization may submit their 510(k)s 
directly to the FDA for review, through either the Traditional, Special, or Abbreviated Programs, 
as appropriate.18, 19, 20 
 
As described in this guidance, the 3P510k Review Program includes features designed to ensure 
a high level of quality in the review of 510(k)s by a 3P510k Review Organization and to 
minimize risks to public health. In evaluating a 3P510k Review Organization for recognition or 
rerecognition, FDA will consider the application, as outlined in Section VIII of this guidance, 
provided by a 3P510k Review Organization. In addition, FDA may consider past premarket 
review performance of the 3P510k Review Organization as described in Section VIII.B.21   
III.  Scope 
 
This guidance outlines FDAs current thinking on key aspects of the 3P510k Review Program, 
including:  
 
1.  FDAs expectations for 3P510k Review Organization reviews of 510(k) submissions, 
including the policy for early interaction consults  (see Section VI) 
2.  Factors used to establish device type eligibility in the 3P510k Review Program (see 
Section V) 
3.  Requirements and recommendations for recognition and rerecognition of 3P510k Review 
Organizations under the 3P510k Review Program (see Section VII) 
4.  Content and format of a 3P510k Review Organizations application for initial recognition 
and rerecognition (see Section VIII) 
5.  Process for suspension or withdrawal of recognition (see Section IX) 
 
16 For a current list of recognized 3P Review Organizations under the 3P Review Program, please visit FDAs 
website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/Accredit.cfm. 
17 For a current list of eligible devices for 3P review under the 3P Review Program, please visit FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
18 The guidance document describing the 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k. 
19 The guidance document for the Abbreviated 510(k) Program is available on FDAs website 
athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program. 
20 The guidance document for the Special 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program. 
21 See section 523(b)(2) and section 523(b)(3) of the FD&C Act. 
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6.  Leveraging the International Medical Device Regulators Forums (IMDRFs) 
requirements for Regulatory Reviewers under the Good Regulatory Review Practices 
(GRRP) and the Medical Device Single Audit Program (MDSAP), as appropriate (see 
Section X) 
 
Currently accredited 3P510k Review Organizations should submit their application materials for 
recognition in the manner described in SectionVIII of this guidance within six months of the 
publication date of this guidance. 
IV.  Definitions  
 
The definitions provided below explain the terms used by FDA in the context of this guidance. 
These terms are not intended to be applied in any context beyond this document and the 3P510k 
Review Program. 
Device Type:  A device type or category as set forth in a section of the Code of Federal 
Regulations, as well as a subset of such device type, such as that set forth in a product code. 
510(k) Submitter:  An entity or person that submits a 510(k) submission to a 3P510k Review 
Organization for the purposes of demonstrating substantial equivalence (SE) of that device to a 
legally marketed device that is not subject to premarket approval (PMA).  
Final Reviewer:  An individual within the 3P510k Review Organization who oversees the 
review of a 510(k) submission throughout the entire review process. The Final Reviewer is a 
regulatory reviewer who meets the criteria of an IMDRF Regulatory Reviewer (defined below) 
and who is responsible for ensuring that final recommendations regarding the device made by the 
Product Specialist (defined separately) are appropriately evaluated, organized, and documented 
before documents are sent to FDA. This individual has sufficient authority and competence 
within the 3P510k Review Organization to independently evaluate the quality and acceptability 
of the 3P510k review documentation. The Final Reviewer is a separate individual from the 
Product Specialist. 
 
IMDRF: International Medical Device Regulators Forum 
 
IMDRF MDSAP Document:  IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2)  
Requirements for Medical Device Auditing Organizations for Regulatory Authority 
Recognition22 produced by the International Medical Device Regulators Forum (IMDRF) 
intended to implement the concept of a Medical Device Single Audit Program (MDSAP).23 This 
document provides criteria for audit programs that FDA believes 3P510k Review Organizations 
should follow, where applicable, and to the extent such criteria are appropriate and consistent 
with the FD&C Act and other applicable laws and regulations.   
 
 
22 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
23 See https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/. 
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IMDRF Medical Device Single Audit Program:  An international program, established by 
IMDRF, specifying a standard set of requirements for the recognition of auditing organizations 
performing regulatory audits of medical device manufacturers and other related functions. 
 
IMDRF Regulatory Reviewer: An individual meeting and fulfilling the competencies, 
commitments, training, and conduct described in IMDRF/GRRP WG/N40 FINAL:2017  
Competence, Training, and Conduct Requirements for Regulatory Reviewers24 produced by 
the International Medical Device Regulators Forum (IMDRF). This is IMDRFs Good 
Regulatory Review Practices (GRRP) document describing criteria for individuals who perform 
regulatory reviews of medical devices for marketing authorization, whether those individuals 
work for governmental regulatory authorities or Conformity Assessment Bodies (CABs)25 that 
FDA believes 3P510k Review Organizations should follow, where applicable, and to the extent 
such criteria are appropriate and consistent with the FD&C Act and other applicable laws and 
regulations.   
 
Product Specialist:  An individual within the 3P510k Review Organization, who meets the 
criteria of an IMDRF Regulatory Reviewer (defined above), and is qualified to review and 
evaluate medical devices within specific device type(s), who may also be qualified for a specific 
technical or clinical specialization (e.g., biocompatibility and Ethylene Oxide (EtO) 
sterilization), based on their scientific background and competence. This individual is the 
primary reviewer responsible for leading the 3P510k Review Organizations review team on a 
given 510(k) submission. The Product Specialist submits their recommendation and all related 
documentation to the Final Reviewer.  
 
Recognition: The process of accrediting 3P510k Review Organizations under section 523 of the 
FD&C Act to review premarket notifications submitted under section 510(k) of the FD&C Act of 
certain eligible devices and make recommendations to FDA regarding the initial classification of 
such devices under section 513(f)(1) of the FD&C Act. 
 
Rerecognition:  The process of renewing the accreditation of 3P510k Review Organizations 
under section 523 of the FD&C Act for an additional three years.  
 
Recognition Criteria: The applicable FD&C Act requirements, including the qualification 
requirements set forth in section 523(b)(3); FDAs recommendations described in this guidance 
document, including those criteria contained in IMDRF MDSAP WG N326, (which include the 
International Organization for Standardization (ISO)/the International Electrotechnical 
Commission  (IEC) 17021:2011 Conformity assessment  Requirements for bodies providing 
audit and certification of management systems, where appropriate and applicable) and IMDRF 
 
24 IMDRF/GRRP WG/N40 Final:2017: Competence, Training, and Conduct 
Requirements for Regulatory Reviewers can be found at http://www.imdrf.org/docs/imdrf/final/technical/imdrf-
tech-170316-competence-conduct-reviewers.pdf. 
25 Conformity Assessment Body (CAB): A body other than a Regulatory Authority engaged in determing whether 
the relevant requirements in technical regulations or standards are fulfilled (GHTF/SG1/N78:2012), IMDRF/GRRP 
WG/N40FINAL:2017, section 3.6.    
26 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition, previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
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GRRP WG N4027; and the criteria to accredit or deny accreditation announced in the Federal 
Register.28  
 
Recognition Denial:  The process of denying an application for accreditation submitted by a 
potential 3P510k Review Organization. 
 
Rerecognition Denial:  The process of denying an application for reaccreditation submitted by a 
recognized 3P510k Review Organization. 
 
Recognition Withdrawal:  The process of withdrawing or suspending accreditation of a 3P510k 
Review Organization in accordance with section 523(b)(2) of the FD&C Act. 
 
Safety Signal: A signal represents a new potentially causal association or a new aspect of a 
known association between a medical device and an adverse event or set of adverse events.29 
 
Technical Expert:  An individual who provides specific knowledge or expertise.  This 
individual may be an employee of a 3P510k Review Organization or may be external as 
described below in Sections VI.B and VII.D of this guidance, respectively. 
 
Third Party (3P510k) Review Organization:  An organization recognized by FDA to review 
510(k) submissions for certain eligible devices as authorized by section 523 of the FD&C Act. 
V.  Factors Used in Determining Device Type Eligibility in 
the 3P510k Review Program  
 
The factors FDA will consider in determining device type eligibility for the 3P510k Review 
Program are as follows: 
 
1.  The risk of the device type, or subset of such device type.30 FDA generally classifies 
medical devices based on risks associated with the device type and whether general 
controls are sufficient to provide a reasonable assurance of the safety and effectiveness of 
the device or there is sufficient information to establish special controls to mitigate such 
risks and provide such assurance.  Devices are classified into one of three regulatory 
classes: class I, class II, or class III.31 In accordance with the statute, class III devices are 
not eligible for 3P510k review.32  
 
 
27 IMDRF/GRRP WG/N40 Final:2017: Competence, Training, and Conduct 
Requirements for Regulatory Reviewers, previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
28 63 FR 28388 (May 22, 1998) is available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf. 
29 See Signal Management Program in Medical Device Safety Action Plan: Protecting Patients, Promoting Public 
Health at https://www.fda.gov/media/112497/download. 
30 See section 523(a)(3)(B)(i)(I) of the FD&C Act. 
31 For more information on the classification of medical devices, please visit FDAs website at 
https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification. 
32 See section 523(a)(3)(A)(i) of the FD&C Act. 
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2.  Whether the device type, or subset of such device type, is intended to be permanently 
implanted in the human body, to sustain human life, or to support human life.  Any 
3P510k Review Organization seeking recognition for review of such device types must 
provide a detailed public health justification explaining why this device type should be 
eligible for 3P510k review33 and how this will positively impact public health.  
 
3.  The extent to which the device type is well understood. For example, devices with novel 
technological characteristics, including some devices requiring complex special controls 
initially classified through the De Novo process may be ineligible for 3P510k review.34  
4.  The extent to which necessary information to make a well-informed recommendation is 
available to 3P510k Review Organizations. If information materially relevant to 
evaluating a device type cannot be shared outside the agency (e.g., it is proprietary), the 
device type may be ineligible for 3P510k review.  
5.  The extent to which the review of the device type does not require multifaceted, 
interdisciplinary expertise.  The following are examples of scenarios that would likely be 
ineligible for 3P510k review due to the need for such expertise:  
a.  the review of some kinds of clinical data or complex non-clinical data (e.g., 
computational modeling);   
b.  a need for consultation across different FDA organizational components, or in 
cross-modality topics (e.g., a multi-reader clinical study);  
c.  a combination product or device type either of which requires review from 
another Center in the Agency; 35  
d.  if a device type raises novel cross-labeling considerations, such as the potential 
for off-label use of drugs (e.g., injector needles or syringes). Cross-labeled 
products usually refer to any drug, device, or biological product packaged 
separately that, according to its proposed labeling, is for use only with another 
individually specified drug, device, or biological product  where both are required 
to achieve the intended use, indication, or effect.36  
However, if a device type contains simple clinical data such as sample clinical images or 
tests using banked specimens, it may be eligible for 3P510k review. Most in vitro 
diagnostic (IVD) devices are eligible for 3P510k review as they typically rely on simple 
clinical studies to demonstrate SE, provided that such devices also meet the other factors 
listed in this section. 
 
33 See section 523(a)(3)(B)(i)(II) of the FD&C Act. 
34 The guidance document describing the De Novo process is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-
evaluation-automatic-class-iii-designation. 
35 For more information on combination products, please visit FDAs website at https://www.fda.gov/combination-
products/about-combination-products/frequently-asked-questions-about-combination-products.  
36 For more information on cross-labeling and diagnostic devices, see the guidance In Vitro Companion Diagnostic 
Devices available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-companion-
diagnostic-devices.    
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6.  The availability of postmarket data suggesting that the device type is the subject of safety 
signals. For example, if a device type is the subject of a safety communication, a high-
risk recall (Class I)37, or postmarket data that indicate a safety signal, this device type 
may be ineligible for 3P510k review.  
For example, as of the date of issuance of this guidance, duodenoscopes have a safety 
signal associated with their reprocessing.38 Because of this safety signal, FDA may 
remove duodenoscopes and accessories from eligibility for the 3P510k Review Program.    
 
FDA will consider each of the above factors in determining device type eligibility for 3P510k 
review. Furthermore, if a device type is considered eligible for 3P510k review, but a proposed 
modification to the device type for a specific submission raises different concerns related to the 
factors listed above, that submission may be determined to be ineligible for 3P510k review. 
  
The product code classification database39 and FDAs list of devices eligible for 3P510k 
review40 has been updated to reflect these eligibility factors to determine 3P510k eligibility for 
device types.  If eligible device types are determined to be ineligible for 3P510k review, or 
ineligible ones are determined to be eligible for 3P510k review, FDA will change their status in 
the database and FDAs publicly-available list.  FDA will periodically review new device types 
using the factors described above to determine whether they are appropriate for 3P510k review, 
and update the database and list accordingly.     
 
 
VI.  Review of 510(k) Submissions by 3P510k Review 
Organizations 
 
FDA believes that 3P510k Review Organizations should conduct FDA-equivalent reviews of 
eligible devices. 3P510k Review Organizations are responsible for reviewing and analyzing 
scientific and technical data in a 510(k) submission to make a recommendation regarding the 
device to the FDA.  3P510k Review Organizations should conduct their review of 510(k)s in the 
manner described in the sections below and in accordance with their own quality control 
practices. Figure 2 identifies the key steps in a 3P510k Review Organizations review of a 510(k) 
submission.41 
 
37 For information on classification of recalls, please visit FDAs website at https://www.fda.gov/medical-
devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices. 
38 Information on safety signals associated with duodenoscopes is available on FDAs website at 
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-
duodenoscope.s 
39 The product code classification database is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 
40 For a current list of eligible devices for 3P review under the 3P Review Program, please visit FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm. 
41 Figure 2 uses IEC/IEC 19510: Information technology  Object Management Group Business Process Model and 
Notation (2013). 
12 
  Contains Nonbinding Recommendations 
 
 
Figure 2: Steps in a 3P510k Review Organizations 510(k) Review 
3P510k Review 
Organization 
refuses to accept  Section VI.D.
3P510k Review  file for review Obtain early 
Organization  interaction 
receives  consult 
submission from  Section VI.A. No Section VI.B. Section VI.C. (as needed)
510(k) Submitter
Assign a Product  Obtain 
Determine  Is the  Yes
Specialist and if  guidance and 
Device  device  Section VI.E.
necessary, a  relevant 
Eligibility eligible?
Technical Expert information Ensure 
submission is 
complete
Section VI.F. Section VI.G. Section VI.H. Section VI.I.
Organize 
Conduct & 
document  Is additional  No Document the  submission 
including 
substantive  info needed? review
3P510k 
review Final ERnedviewer 
documentation
submits 
Yes recommendation 
and submission 
to FDA
Receive additional Request additional 
 information information
 from 510(k) submitter from 510(k) submitter
                
                           
  Determine device eligibility for 3P510k review 
 
Before reviewing a 510(k) submission, a 3P510k Review Organization should determine whether 
it has the expertise to review the device type and whether that device type is eligible for 3P510k 
review based on review of the product code classification database42 or the FDA Third Party 
Review public website.43 If the 3P510k Review Organization lacks the expertise or the device is 
not eligible for 3P510k review, the 3P510k Review Organization should not accept the 510(k) 
for review from the 510(k) Submitter.  If the 3P510k Review Organization determines the device 
is ineligible for 3P510k review after it has already accepted the 510(k) submission, the 3P510k 
Review Organization should immediately inform the 510(k) Submitter and discontinue the 
review.   
If the 3P510k Review Organization submits a 510(k) submission to FDA for an ineligible device, 
or a device the 3P510k Review Organization is not recognized to review (see Section VIII.A), 
FDA will place the submission on hold and notify the 3P510k Review Organization of FDAs 
eligibility assessment. Unless the 3P510k organization intends to address the eligibility concerns, 
it should promptly consult with the 510(k) Submitter and, if the 510(k) Submitter concurs, 
promptly send a 510(k) withdrawal request to FDA. If the 3P510k Review Organization does not 
address eligibility concerns or withdraw the submission within 180 days, FDA will delete the 
file. A 510(k) Submitter cannot submit a 510(k) for the same device directly to FDA until the file 
 
42 The product code classification database is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 
43 For a list of eligible devices for 3P review under the Third Party Review Program, please visit FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm. 
13 
  Contains Nonbinding Recommendations 
 
is withdrawn voluntarily by the 3P510k Review Organization or deleted automatically by FDA 
after 180 days. If a 3P510k Review Organization is unclear regarding the eligibility status of a 
device, it should contact the 3P510k inbox at 3P510K@fda.hhs.gov to seek clarification.     
 
  Assign a Product Specialist(s) and Technical Expert(s) to   
conduct the substantive review of a 510(k) submission 
 
3P510k Review Organization personnel should have appropriate education, training, skills, 
technical knowledge, qualifications, and experience to perform 510(k) reviews for the device 
type(s) their organization is recognized to review. For additional discussion on FDAs 
recommendations regarding qualifications of personnel, see Section VII.C of this guidance. 
  
Each 510(k) submission should be assigned to a Product Specialist with appropriate expertise for 
the type of device under review. The Product Specialist may add qualified Technical Experts to 
the review team to ensure sufficient competency in the review, if necessary. The Product 
Specialist should document the competencies of, and the rationale for, choosing to use any 
Technical Experts.  Particular attention should be given to the expertise and impartiality of any 
external Technical Experts. For more information on using external Technical Experts, please 
see Section VII.D of this guidance.   
 
  Obtain relevant FDA guidance(s) and information 
 
3P510k Review Organizations should review and be familiar with publicly available information 
relevant to their review.  For example:  
 
1.  3P510k Review Organizations should review FDAs guidance database to obtain any 
relevant final guidance documents44 when conducting their reviews, including device-
specific and horizontal guidances (e.g., biocompatibility, software, sterility).  
 
In addition, 3P510k Review Organizations should be aware of any special controls, 
which are regulatory requirements for certain class II devices, that apply to that device 
type under review.  For information on whether a device type has applicable special 
controls, 3P510k Review Organizations should review the proposed classification 
regulation of the device under Title 21 of the Code of Federal Regulations (CFR),45 
which will identify the mandatory special controls for a particular device type.   
 
 
44 The guidance database search engine allows users to search the inventory of guidances available by title, words, 
or origin and is available on FDAs website at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents   
45 The Code of Federal Regulations Title 21 database is available at https://www.ecfr.gov/cgi-
bin/ECFR?page=browse  
14 
  Contains Nonbinding Recommendations 
 
2.  3P510k Review Organizations should review FDAs postmarket databases, including 
recalls, market withdrawals, and safety reports;46 Medical Device Reports;47 and MedSun 
Reports48 for the predicate device and/or the device type to identify any issues with 
clinical use of similar devices that should be considered and addressed in the review of 
the subject device. If potential safety signals are identified by a 3P510k Review 
Organization, it should contact FDA for information on current review practice (see 
SectionVI.D below).    
 
3.  3P510k Review Organizations should review publicly available premarket review 
information in FDAs 510(k) database for information about the legally marketed device 
(predicate) to which a Submitter is comparing its device, or other similar devices,49 
including Indications for Use Statements, 510(k) Summaries,50,51 Decision Summaries (if 
available), and FDA decision letters. In some instances, a devices product code can also 
be used to identify a generic category of a device and assist with the identification of 
similar devices. Product codes can be found in FDAs product code database.52  
  
4.  If an applicant wishes to utilize standards, the 3P510k Review Organization should 
review FDAs guidance document entitled Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices.53  
 
3P510k Review Organizations should request that 510(k) Submitters fully inform them of any 
prior communications with FDA about a device under review, including but not limited to FDA 
feedback obtained through the Q-Submission program, unsuccessful marketing applications,  and 
other interactions.  If applicable, 3P510k Review Organizations should be familiar with the FDA 
Q-Submission Program, including the Pre-Submission process, through the guidance document 
entitled, Requests for Feedback and Meetings for Medical Device Submissions: The Q-
 
46 The recalls database allows users to search for recalls and correction or removal actions initiated by a firm prior to 
recall classification and is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. 
47 The MAUDE database allows users to search for Medical Device Reports and is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm.  
48 The MedSun database allows users to search for adverse event reports from the Medical Product Safety Network 
and is available on FDAs website at  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm.  
49 The 510(k) database search engine allows users to search all previously cleared 510(k) submissions by 510(k) 
number, applicant name, device name, product code, etc., and is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. 
50 510(k) Summaries should be written in accordance with 21 CFR 807.92 and is available at 
https://www.ecfr.gov/cgi-bin/text-
idx?SID=7272ad96195b5a401402c8b22c785d10&mc=true&node=se21.8.807_192&rgn=div8. 
51 The guidance document describing 510(k) Summaries is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k.   
52 The product code database is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.    
53 The guidance document describing the use of standards to determine substantial equivalence is available on 
FDAs website at  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
15 
  Contains Nonbinding Recommendations 
 
Submission Program.54  A 3P510k Review Organization should request that the authorization 
letter from the 510(k) Submitter grant FDA permission to discuss previous submissions, 
identified by submission numbers, with the 3P510k Review Organization (see Section VI. I). If 
applicable, the 3P510k Review Organization should coordinate with the 510(k) Submitter to 
obtain and review prior submission content for the device, any written feedback or meeting 
minutes resulting from prior interactions, and any additional data, studies and/or study protocols 
submitted in response to previous submissions by the 510(k) Submitter prior to submitting the 
current submission to FDA.  
 
3P510k Review Organizations should also request that 510(k) Submitters submit only one 510(k) 
for a specific device at a time. 
  Early Interaction with FDA (as needed)  
 
3P510k Review Organizations should interact, as needed, with appropriate FDA staff prior to, 
and during the review of, 510(k) submissions. Early interactions  those between the 3P510k 
Review organization and FDA prior to the substantive review  can be an important part of the 
510(k) review process (for potential topics, refer to section VI.C). These interactions help ensure 
timely and consistent 510(k) reviews by assisting in device eligibility determinations and 
identifying relevant issues and contemporary review criteria.  
 
In their initial recognition applications, 3P510k Review Organizations commit to early 
interaction with FDA before reviewing a device type they have not previously reviewed (see 
Section VIII.A). This ensures the 3P510k Review Organization has the latest FDA thinking on 
relevant guidance, standards, and other considerations for that device type. FDA also encourages 
early interaction for all 3P510k submissions, particularly for the first review of any device type 
by an individual Product Specialist and for any subset of device type (i.e., device type by product 
code) they have not recently reviewed. Generally, FDA considers a recent review to be within 
the last six months.  
 
Procedures on how to obtain early interaction will be available on the FDA Third Party public 
website. FDA intends to respond to 3P510k Review Organization requests within 2 business 
days. If that deadline cannot be met, FDA will work with the 3P510k Review Organization to 
establish a reasonable timeline for a response.  
 
  Ensure a submission is administratively complete 
 
To ensure that a submission is administratively complete, 3P510k Review Organizations should 
conduct an acceptance review of the 510(k) submission based on 510(k) regulations from 21 
CFR 807.87 to 807.100 to assess whether the 510(k) submission includes all the information 
necessary to conduct a substantive review and to reach a recommendation (e.g., SE or NSE) as 
defined under section 513(i) of the FD&C Act to submit to FDA.  FDA recommends that 3P510k 
 
54The guidance document describing the Q-Submission program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
16 
  Contains Nonbinding Recommendations 
 
Review Organizations use the Refuse to Accept (RTA) checklist for 510(k) submissions to make 
the determination regarding whether a submission is administratively complete.  For more 
information on the RTA checklist, please see FDAs guidance document entitled Refuse to 
Accept Policy for 510(k)s. 55  
 
3P510k Review Organizations should not act as a consultant for the 510(k) Submitter. It is the 
responsibility of the 510(k) Submitter to be familiar with the content and format requirements of 
a 510(k) prior to submitting to a 3P510k Review Organization. If a Submitter is not familiar with 
the 510(k) regulatory pathway, 3P510k Review Organizations should direct them to resources 
such as FDAs guidance documents entitled, The 510(k) Program: Evaluating Substantial 
Equivalence in Premarket Notifications [510(k)],56 
The Abbreviated 510(k) Program,57 The Special 510(k) Program,58 or the Division of 
Industry and Consumer Education in the Office of Communication and Education.59 
 
If the 3P510k Review Organization determines that a submission is administratively complete, 
the organization should begin its substantive review of the 510(k) submission. If the 3P510k 
Review Organization identifies any deficiencies in the 510(k) submission, it should contact the 
510(k) Submitter to request the missing information.  
 
 
 
  Conduct the substantive review of a 510(k) submission 
Substantive review focuses on the evaluation of SE as defined in section 513(i) of the FD&C 
Act. 21 CFR 807.100(b) sets forth the criteria that FDA uses to determine whether a device is 
substantially equivalent to a legally marketed device. For information on making an SE 
determination under the 510(k) program, please see FDAs guidance document entitled The 
510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].60  
 
55 The guidance document for Refuse to Accept policy is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks. 
56 The guidance document for the 510(k) Program is available on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-
notifications-510k.  
57 The guidance document for the Abbreviated 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program. 
58 The guidance document for the Special 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program. 
59 The contact information for the Division of Industry and Consumer Education is available on FDAs website at 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-
industry-and-consumer-education-dice. 
60 The guidance document used to determine the substantial equivalence of a device is available on FDAs website 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k. 
17 
  Contains Nonbinding Recommendations 
 
For information on Abbreviated and Special 510(k)s, see FDAs guidance documents entitled 
The Abbreviated 510(k) Program61 and The Special 510(k) Program.62  
 
3P510k Review Organizations should identify at least one Final Reviewer within its organization 
who is independent from prior review of the submission and is responsible for providing a final 
supervisory assessment of the Product Specialists work before it is submitted to FDA. This 
individual should have sufficient authority and competence to independently assess the quality 
and acceptability of the Product Specialists review of the 510(k) submission.  
If 3P510k Review Organizations identify any deficiencies during their substantive review, they 
should contact the 510(k) Submitter with a request that the deficiencies be addressed. Section 
VI.G below provides further instruction on how to identify deficiencies in a 510(k) submission.  
When the substantive review is complete, the Product Specialist(s), Technical Expert(s), if 
applicable, and Final Reviewer should reach an agreement on a final recommendation (e.g., SE 
or NSE to a predicate device) before submitting the recommendation to FDA.   
  Identify deficiencies in a 510(k) submission 
 
If a 3P510k Review Organization identifies any deficiencies during their review, it should 
contact the 510(k) Submitter. 3P510k Review Organizations may use any form of 
communication (i.e., telephone, facsimile, electronic mail, or letter) to resolve the matter 
provided confidentiality is maintained and the interaction is documented. 3P510k Review 
Organizations should, however, avoid the exchange of substantive data and information solely 
over the telephone to avoid errors that may arise in the absence of a written request and response.   
As part of providing an FDA-equivalent review, when requesting additional information from a 
510(k) Submitter, 3P510k Review Organizations should structure their additional information 
requests as described in FDAs guidance document entitled Developing and Responding to 
Deficiencies in Accordance with Least Burdensome Provisions. 63 This guidance document has 
examples of well-constructed deficiencies and responses to FDAs requests.   
3P510k Review Organizations should document the deficiencies, the 510(k) Submitters 
response to the deficiencies, and the discussion on the adequacy of the response in the 3P510k 
Review Organizations review memorandum sent to FDA. The review memorandum should also 
provide to FDA a copy of all written communications related to resolving the deficiencies 
between the 510(k) Submitter and the 3P510k Review Organization (e.g., electronic mail, letters, 
summary of teleconferences). If the 510(k) Submitter made any modifications to the submission 
in response to a deficiency (e.g., revised 510(k) summary), the 3P510k Review Organization 
should document this modification and request that the 510(k) Submitter provide the latest 
 
61 The guidance document for the Abbreviated 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program. 
62 The guidance document for the Special 510(k) Program is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program. 
63 The guidance document on developing and responding to deficiencies is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-responding-
deficiencies-accordance-least-burdensome-provisions. 
18 
  Contains Nonbinding Recommendations 
 
version of the 510(k) submission prior to the 3P510k Review Organization submitting to FDA. 
For example, if the Product Specialist requested an updated device description, the latest version 
should be in the 510(k) submission to FDA. However, the original device description and the 
deficiency requesting an updated device description should be found in the review memo. This 
will ensure that FDA has the correct version of the 510(k) submission on record. Proper 
documentation will ensure that the 3P510k Review Organization does not have or appear to have 
the role of a consultant.   
  Document a 510(k) review 
 
Once a 3P510k Review Organization has made a final recommendation, it should prepare their 
review documentation specifying the reasoning and steps that led to their final recommendation.  
21 CFR 10.70 (Documentation of significant decisions in administrative file) provides a 
framework that should be utilized by 3P510k Review Organizations. The content of the review 
documentation will vary based on the type of 510(k) submission and device. Recommended 
review memorandum examples for documentation purposes will be available on the FDA Third 
Party public website.64  
 
If standards are referenced in a submission, FDA recommends 3P510k Review Organizations 
discuss in their review memorandum how they were utilized in the 510(k) submission. 
Submitters and 3P510k Review Organizations should consult the FDA guidance entitled, 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices65 for use of FDA-recognized consensus standards and use of other standards. 
 
In addition to noting whether or not the necessary information required in a 510(k) submission 
was included,66 the review memorandum should also convey how a 3P510k Review 
Organization made their recommendation regarding the device. A thorough and substantive 
review memorandum should discuss the adequacy of each section of the submission. In general, 
FDA believes it will not be sufficient to state that a section of the 510(k) submission or a 
response to a deficiency was adequate without providing an explanation of how the 3P510k 
Review Organization came to that determination.  
 
To facilitate FDAs review process, 3P510k Review Organizations should reference sections and 
page numbers of the 510(k) submission in their review memorandum where possible. 3P510k 
Review Organizations should also clearly document in the review memorandum any 
deficiencies, the response to the deficiencies, and the 3P510k Review Organizations review of 
the response as indicated in Section VI.G.  
 
The review memorandum is the only means by which FDA can understand how and why a 
3P510k Review Organization recommended a device to be SE (or NSE) to the predicate device. 
 
64Review examples will be available on FDAs third party website: https://www.fda.gov/medical-devices/premarket-
submissions/510k-third-party-review-program. 
65 The guidance on use of consensus standards is available on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-
submissions-medical-devices.  
66 See 21 CFR 807 Subpart E. 
19 
  Contains Nonbinding Recommendations 
 
Thorough and clear documentation will reduce the need for FDA to re-review the submission 
itself and increase the efficiency of FDAs final review.67  
  Organize and submit a 510(k) submission including   
  associated 3P510k review documentation   
 
Upon completing the review of a 510(k) submission, the Final Reviewer should submit two 
separate eCopy documents to FDAs Document Control Center,68 the 510(k) submission 
generated by the 510(k) Submitter and the 3P510k review documentation generated by the 
3P510k Review Organization.    
 
Since there are two distinct parties involved in the generation of a 3P510k submission, the 
3P510k Review Organization and the 510(k) Submitter, each is subject to the eCopy 
requirements and each must provide their own eCopy and company cover letter with an eCopy 
statement and signature (see section 745A(b) of the FD&C Act ).  The 510(k) Submitter should 
take care to submit the latest version of the 510(k) submission. This version should include any 
documents that have been updated in response to deficiencies from the 3P510k Review 
Organization. Please refer to FDAs guidance entitled eCopy Program for Medical Device 
Submissions69 for more information on how to submit through the eCopy program.  
 
 
 
To facilitate FDAs review, we recommend that a 3P510k Review Organizations 510(k) 
documentation include the following: 
 
(1) A cover letter signed by the Final Reviewer that clearly identifies:  
 
a.  The purpose of the submission 
 
b.  The name and address of the 3P510k Review Organization and the contact person 
 
c.  The name, email address, and telephone number of the Final Reviewer 
 
d.  The name and address of the 510(k) Submitter 
 
 
67 Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of 
eliminating routine re-review by FDA of 3P reviews: See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 
2017) (Food and Drug Administration User Fee Reauthorization), also available at 
https://www.fda.gov/media/102699/download. See also Eliminating Routine FDA Re-Review of Third Party 
510(k) Reviews, available at https://www.fda.gov/media/116168/download.     
68 The address for CDRHs Document Control Center is available on FDAs website at 
https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-medical-device-
submissions.  
69 The guidance document on eCopies is available on FDAs website at  https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.  
20 
  Contains Nonbinding Recommendations 
 
e.  The name of the device (trade name, common or usual name, FDA classification 
regulation name, classification regulation number, and product code, as applicable) 
 
f.  The 3P510k Review Organizations recommendation (SE or NSE) with respect to the 
device  
 
g.  The date the 3P510k Review Organization first received the 510(k) from the 
Submitter 
 
(2) A letter signed by the 510(k) Submitter authorizing the 3P510k Review Organization to 
submit the 510(k) to FDA on their behalf and authorizing the 3P510k Review 
Organization to discuss the contents of the 510(k) with FDA on their behalf. This letter 
should also authorize FDA to discuss other, related submission(s) from the same 510(k) 
submitter with the 3P510k Review Organization and should include a list of those 
submission numbers.   
 
(3) A signed certification that the reported information accurately reflects the data reviewed 
and that no material fact has been omitted. This certification should also state that the 
3P510k Review Organization continues to meet personnel qualifications and prevention 
of conflicts of interest criteria reviewed by FDA; that the 3P510k Review Organizations 
review is based on the 510(k) that it is submitting with the review; and that the 3P510k 
Review Organization understands that the submission of false information to the 
government is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).  
 
(4) A table of contents listing the sections where the 510(k) submission and associated 
3P510k review documentation are located, along with the corresponding page numbers.  
 
(5) A summary of any early interaction consults that occurred prior to the 510(k) submission 
to FDA with FDA staff, if appropriate (see Section VI.D of this guidance). 
 
(6) The 510(k) Submitters complete 510(k) submission that conforms to FDA's 
requirements for content and format as provided in 21 CFR part 807 subpart E. The 
510(k) submission should be prepared by the 510(k) Submitter, not the 3P510k Review 
Organization. This information should be separate from the 3P510k Review 
Organizations documentation and should be the latest version. Please see Section VI.G 
for more information.  Proper documentation will ensure that the 3P510k Review 
Organization does not have or appear to have the role of a consultant.   
 
(7) An acceptance review of the 510(k) submission based on objective criteria using the RTA 
checklist, discussed in Section VI.E of this guidance, to assess whether the submission is 
administratively complete and includes all of the information necessary for the 3P510k 
Review Organization to conduct a substantive review on FDAs behalf. 
 
(8) A review memorandum including complete documentation of the 3P510k Review 
Organizations review of the 510(k) submission as described in Sections VI.G and VI.H 
of this guidance, signed by all personnel who conducted the review (generally the 
21 
  Contains Nonbinding Recommendations 
 
Product Specialist(s), Technical Expert(s), when applicable, and Final Reviewer), with a 
decision recommendation.  
 
FDA will begin its review of the 3P510k Review Organizations recommendation only after it 
receives all documentation it believes is needed to conduct its review.  
 
  Submit additional information upon FDAs request 
 
After a 3P510k Review Organization has submitted their 510(k) recommendation, including the 
associated 3P510k review documentation, FDA will begin to review the 3P510k review 
documentation, and if necessary, the 510(k) submission. If FDA determines that additional 
information is needed to make an SE determination, it will contact the 3P510k Review 
Organization either by telephone or email.70  Such requests will describe FDAs concerns with a 
510(k) submission, and identify the information needed to address those concerns.  
 
If FDA places a 510(k) submission on hold (i.e., officially suspends review of the submission 
pending FDAs receipt of additional information), it will send an email informing the 3P510k 
Review Organization of the on hold status and request additional information.  For more 
information on a request for additional information, please see FDAs guidance entitled FDA 
and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review 
Clock and Goals.71  
Upon receiving a request from FDA for additional information, the 3P510k Review Organization 
should: 
(1) Promptly inform the 510(k) Submitter of FDAs request for additional information 
relating to the 510(k) submission and request that the 510(k) Submitter provide responses 
to the 3P510k Review Organization in writing. 
 
The 3P510k Review Organization should be involved in any discussions with FDA 
regarding the request for additional information, such as if the 510(k) Submitter seeks 
clarification or a Submission Issue Meeting72 with FDA; 
(2) Thoroughly review any additional information provided by the 510(k) Submitter to 
ensure that it adequately responds to FDAs concerns; 
 
 
70 Through the MDUFA IV Commitment Letter, FDA commits to improving the 3P Review Program with a goal of 
eliminating routine re-review by FDA of 3P reviews: See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 
2017) (Food and Drug Administration User Fee Reauthorization), also available at 
https://www.fda.gov/media/102699/download. 
71 The guidance document on FDA review clocks is available on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-
effect-fda-review-clock-and-goals.  
72 Submission Issue Meetings are discussed in the guidance document on the Q-Submission program, available on 
FDAs website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-
and-meetings-medical-device-submissions-q-submission-program.  
22 
  Contains Nonbinding Recommendations 
 
(3) Document their review of the response to the deficiency by providing a clear and 
thorough assessment of whether and how the response adequately addresses FDAs 
deficiency  this should include updating the review documentation accordingly; 
 
(4) Prepare a cover letter referencing the 510(k) number previously assigned by FDA and 
identifying the purpose of the new submission (i.e., response to deficiencies);  
 
(5) Send the cover letter, their additional or revised review documentation, and any 
additional information received from the 510(k) Submitter to FDAs Document Control 
Center.73   
The 3P510k Review Organization must provide the two separate eCopy documents74 (the new 
submission eCopy document generated by the 510(k) Submitter and the eCopy document 
generated by the 3P510k Review Organization). Each eCopy should be clearly marked as 
belonging to the 3P510k Review Organization or the 510(k) Submitter as appropriate. For 
information on the eCopy program, see Section VI.I of this guidance. 
 
FDA will begin its review after it receives the 510(k) Submitters response to the additional 
information request, documentation of the 3P510k Review Organizations review, and the 
3P510k Review Organizations determination of the adequacy of the response to additional 
information requests. 
 
  510(k) submission dispute resolution 
 
FDA has developed guidance documents that provide an overview of the appeals processes 
available for medical devices (see FDAs guidances entitled Center for Devices and 
Radiological Health Appeals Processes75 and Center for Devices and Radiological Health 
Appeals Processes: Questions and Answers About 517A76). The processes for reviewing and 
reconsidering FDA decisions or actions on other 510(k) submissions are also available for 
3P510k submissions when a dispute between FDA and a 510(k) Submitter arises. 
 
Disputes are often the result of misunderstanding or miscommunication, and FDA encourages 
3P510k Review Organizations to seek clarification, as needed, from FDA or the 510(k) 
Submitter during a review. If the 510(k) Submitter disagrees with an FDA decision or action, the 
3P510k Review Organization should maintain impartiality and exercise care to avoid the 
 
73 The address for CDRHs Document Control Center is available on FDAs website on the page describing the 
eCopy program at https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-
medical-device-submissions. 
74 The guidance document describing the eCopy Program is available on the FDAs website at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
75 The guidance document describing the CDRH appeals process is available on FDAs website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-
cdrh-appeals-processes. 
76 The guidance document on the CDRH appeals process, specifically regarding 517A is available on FDAs website 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-
health-cdrh-appeals-processes-questions-and-answers-about-517a. 
23 
  Contains Nonbinding Recommendations 
 
appearance of conflict of interest that may result from acting as an advocate on the 510(k) 
Submitters behalf.    
 
If a 510(k) Submitter would like to issue a complaint against a 3P510k Review Organization, 
communication should be sent to 3P510K@fda.hhs.gov.  
VII. Requirements and Recommendations for Recognition 
and Rerecognition of Third Party Review Organizations  
 
In this section of the guidance, FDA describes the criteria considered in recognizing 3P510k 
Review Organizations to conduct premarket reviews of eligible 510(k)s as established by 
FDASIA. 
 
In accordance with section 523(b)(3) of the FD&C Act, a 3P510k Review Organization shall, at 
a minimum, meet the following qualification requirements. Such person: 
 
(1) May not be an employee of the Federal Government 
 
(2) Shall be an independent organization, which is not owned or controlled by a 
manufacturer, supplier, or vendor of devices, and which has no organizational, material, 
or financial affiliation with such a manufacturer, supplier, or vendor. 
 
(3) Shall be a legally constituted entity permitted to conduct the activities for which it seeks 
recognition 
 
(4) Shall not engage in the design, manufacture, promotion, or sale of devices 
 
(5) The operations of such person shall be in accordance with generally accepted 
professional and ethical business practices 
 
(6) Shall agree, at a minimum, to include in its request for accreditation a commitment to, at 
the time of accreditation, and at any time it is performing any review pursuant to section 
523:  
 
a.   Certify that reported information accurately reflects data reviewed 
 
b.   Limit work to that for which competence and capacity are available 
 
c.  Treat information received, records, reports, and recommendations as proprietary 
information 
 
d.  Promptly respond and attempt to resolve complaints regarding its activities for which 
it is recognized 
 
e.  Protect against the use, in carrying out the review of a 510(k) submission and initial 
classification of a device, of any officer or employee of the person who has a 
24 
  Contains Nonbinding Recommendations 
 
financial conflict of interest regarding the device, and annually make available to the 
public disclosures of the extent to which the 3P510k Review Organization, and the 
officers and employees of the 3P510k Review Organization, have maintained 
compliance with requirements relating to financial conflicts of interest 
 
In addition to these minimum requirements set forth in the FD&C Act, a 3P510k Review 
Organization should meet additional qualifications announced in the Federal Register.77 These 
qualifications include establishing policies designed to identify, prevent, and ensure reporting to 
FDA, of instances where 510(k) Submitters submit substantially the same submission to multiple 
3P510k Review Organizations in order to find the one most likely to recommend a substantial 
equivalence (SE) determination of the 510(k).  Such a practice would undermine the 
independence and integrity of the 3P510k Review Program.78 Other qualifications listed in the 
Federal Register or that have been previously identified through guidance are discussed below. 
 
  Operational considerations 
 
All submissions and communications with FDA and all documentation pertaining to the review 
of a 510(k) submitted to FDA should be in English. For foreign 3P510k Review Organizations, a 
United States representative should be designated so that FDA can efficiently communicate with 
the 3P510k Review Organization while conducting its review (see Section VIII.A(1)). 
 
  Management of impartiality 
 
FDA expects 3P510k Review Organizations to be impartial and free from any commercial, 
financial, and other pressures that might present a conflict of interest or an appearance of a 
conflict of interest. Therefore, FDA will consider whether the potential 3P510k Review 
Organization has established, documented, and executed policies and procedures to prevent any 
individual or organizational conflict of interest or the appearance of a conflict of interest, 
including conflicts of interests pertaining to their external Technical Experts. Policies and 
procedures intended to address this issue should be consistent with IMDRF MDSAP WG/N3 
FINAL: 2016 (Edition 2)  Requirements for Medical Device Auditing Organizations for 
Regulatory Authority Recognition79 and IMDRF GRRP WG/N40 FINAL:2017  Competence, 
Training, and Conduct Requirements for Regulatory Reviewers. 80  For more information on  
IMDRF GRRP and MDSAP, see Section X of this guidance below. 
 
FDA recommends that 3P510k Review Organizations also address the following to prevent a 
potential conflict of interest: 
 
77 63 FR 28388 (May 22, 1998) is available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf. 
78 As noted in 63 FR 28390 (May 22, 1998), available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-
13799.pdf.  
79 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition, previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
80IMDRF GRRP WG/N40 Final:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers", previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
25 
  Contains Nonbinding Recommendations 
 
 
(1) 3P510k Review Organizations should not participate in the preparation of 510(k)s if 
involved in 510(k) reviews. For more information, see Section VI.E of the guidance. 
 
(2) 3P510k Review Organizations should not task an individual, whether employee or 
contractor, with reviewing a 510(k) submission, if that individual was employed 
within the last twelve months by that 510(k) Submitter or by a firm who helped 
prepare that 510(k) submission. Personnel should not review a medical device that 
they developed, helped develop, or prepared for submission.  
 
(3) 3P510k Review Organizations should not promise or advertise any guarantees for 
FDA clearance. 
 
Information on the conflict of interest standards FDA applies to its own review personnel is 
included in the document entitled Standards of Ethical Conduct for Employees of the Executive 
Branch.81 3P510k Review Organizations are encouraged to refer to these standards in 
safeguarding their operations against conflicts of interest. 
 
The conflict of interest policies for a 3P510k Review Organization should be fully implemented 
and there should be an attestation that those policies have been implemented that is signed  by 
the most responsible individual at the organization before any 510(k) is accepted for review. 
When using external technical experts, see Section VII.D regarding conflicts of interest 
safeguards.  
 
  Personnel involved in reviewing activities82 
 
FDA expects that 3P510k Review Organizations and their personnel should demonstrate 
knowledge and experience with the following, as applicable: 
 
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
 
(2) The Public Health Service Act (42 U.S.C. 201 et seq.) 
 
(3) Regulations in the Code of Federal Regulations implementing these statutes,   
particularly 21 CFR Parts 800 through 1299.  
 
Additionally, the 3P510k Review Organization should: 
 
(4) Establish, document, and execute policies and procedures to ensure that 510(k)s are  
reviewed by qualified personnel. 
 
 
81 Standards of Ethical Conduct for Employees of the Executive Branch is available at: 
https://www.oge.gov/Web/oge.nsf/0/076ABBBFC3B026A785257F14006929A2/$FILE/SOC%20as%20of%2081%
20FR%2081641%20FINAL.pdf.  
82 Additional information on the criteria for personnel qualifications is available in the Federal Register notice 
published on 63 FR 28388 (May 22, 1998) at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf. 
26 
  Contains Nonbinding Recommendations 
 
(5) Maintain records on the relevant education, training, skills, and experience of all 
personnel who contribute to the technical review of a 510(k). 
 
(6) Make available to its personnel clear written instructions for duties and 
responsibilities with respect to 510(k) reviews. 
 
(7) Employ personnel who are qualified in all the scientific disciplines relevant to the 
510(k)s that the 3P510k Review Organization accepts for review. 
 
(8) Identify at least one individual who is responsible for providing supervision over 
510(k) reviews and who has sufficient authority and competence to assess the quality 
and acceptability of these reviews. 
 
In addressing the items enumerated above in this section, 3P510k Review Organizations should 
be consistent with IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2)  Requirements for 
Medical Device Auditing Organizations for Regulatory Authority Recognition83, including, but 
not limited to, maintaining a quality management system, and  
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers".84 For more information on IMDRF GRRP and 
MDSAP, see Section X of this guidance below. 
 
In addition, 3P510k Review Organizations will be expected to consult national and/or 
international standards recognized by FDA as well as FDA guidance documents. 3P510k Review 
Organizations should have the capability to interface with FDAs electronic data systems and 
websites through which the 3P510k Review Organization can search for relevant guidance 
documents, recognized standards, predicate summaries, and publicly available information 
regarding adverse events and recalls when performing premarket review of similar devices. 
 
3P510k Review Organizations must certify in their application that designated personnel will 
attend FDAs training for recognition and rerecognition (see Section VIII.A of this guidance and 
the Federal Register notice published on May 22, 1998 (63 FR 28388)). 3P510k Review 
Organizations are expected to complete training before conducting any 510(k) reviews under the 
program. FDA will not accept 510(k) reviews and recommendations from 3P510k Review 
Organizations that have failed to have at least one designated person attend a FDA training 
session for recognition.   
 
3P510k Review Organizations should be prepared to conduct technically competent 510(k) 
reviews before requesting recognition by FDA. FDA recommends persons involved in a 510(k) 
submission review at a 3P510k Review Organization meet the appropriate qualifications (e.g., 
specialized education and experience) provided in this guidance. When a 3P510k Review 
Organization requests to expand the scope of device types for which it may review 510(k) 
 
83 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition, previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
84 IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers", previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
27 
  Contains Nonbinding Recommendations 
 
submissions, it should ensure through its policies and procedures in place that its staff are 
qualified in the scientific disciplines for the new device types.  
 
  Use of external Technical Experts 
 
The following are FDAs recommendations when 3P510k Review Organizations use an external 
Technical Expert: 
 
(1) The 3P510k Review Organization should ensure that external Technical Experts meet 
the same standards as those who work within the 3P510k Review Organization, such 
as freedom from conflicts of interest;  
 
(2) The 3P510k Review Organization should ensure that external Technical Experts are 
discouraged from subcontracting parts of their contract to subcontractors, and if they 
do so, then the external Technical Expert should ensure that the subcontractor meets 
all requirements applicable to the external Technical Expert.;  
 
(3) 3P510k Review Organizations should maintain records of the qualifications of 
external Technical Experts, in addition to evidence of regular monitoring of the 
established competence, conflicts of interest and the degree of fulfillment of the 
outsourced work 
 
To ensure that 3P510k Review Organizations have sufficient competence among their own staff, 
there should be at least one qualified Product Specialist per device type that the 3P510k Review 
Organization is recognized to review. This is to ensure that there is not excessive reliance on 
external expertise by a 3P510k Review Organization and to enable appropriate oversight of the 
qualifications of external Technical Experts by 3P510k Review Organizations. 
 
In addressing the items above, 3P510k Review Organizations should be consistent with IMDRF 
MDSAP WG/N3 FINAL: 2016 (Edition 2):  Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition85 and  
IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers".86  For more information on IMDRF GRRP and 
MDSAP, see Section X of this guidance below. 
 
  Confidential information 
 
A 3P510k Review Organization is required to treat information received, records, reports, and 
recommendations as proprietary information (see section 523(b)(3)(F)(iii) of the FD&C Act ) 
and may not disclose confidential commercial information or any trade secret (see section 
 
85 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
86 IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers", previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
28 
  Contains Nonbinding Recommendations 
 
301(y)(2) of the FD&C Act). Also, in accordance with 21 CFR 807.95, when a 510(k) is 
submitted by a device manufacturer to FDA, FDA will not publicly disclose that submission if 
certain conditions are met. Thus, a 3P510k Review Organization should not publicly disclose a 
510(k) submission for a device that is not currently on the market and where the intent to market 
the device has not been disclosed.   
 
FDA will determine whether information submitted to FDA by a 3P510k Review Organization 
can be released in accordance with the Trade Secrets Act, Freedom of Information Act, 21 CFR 
part 20 and 21 CFR 807.95, regarding confidentiality of information in 510(k)s. In general, as 
with 510(k)s submitted directly to FDA, 510(k)s submitted by 3P510k Review Organizations 
and associated review documentation will be available for disclosure by FDA after the agency 
has issued an SE decision for a device, unless the information is exempt from public disclosure 
under 21 CFR part 20 or 21 CFR 807.95. If necessary, a copy of the 510(k) will be provided to 
the manufacturer for predisclosure notification according to  20.61.  
 
In addition, information submitted by a 3P510k Review Organization to obtain recognition or 
rerecognition from FDA will be available for disclosure, unless exempted under 21 CFR part 20. 
 
  Complaints regarding 510(k) Submitters 
 
The 3P510k Review Organization should send to FDA via e-mail to 3P510K@fda.hhs.gov  
information on any complaint (e.g., whistleblowing) it receives about a 510(k) Submitter that 
could indicate an issue related to the safety or effectiveness of a medical device or a public 
health risk. 
 
  Third Party Review Organization recordkeeping  
 
Pursuant to section 704(f) of the FD&C Act, a 3P510k Review Organization must maintain 
records that support their initial and continuing qualifications to receive FDA recognition. These 
records must include the following: 
 
(1) Documentation of the training and qualifications of the 3P510k Review Organization 
and its personnel; 
 
(2) The procedures used by the 3P510k Review Organization for handling confidential 
information;  
 
(3) The compensation arrangements made by the 3P510k Review Organization; and 
 
(4) The procedures used by the 3P510k Review Organization to identify and avoid 
conflicts of interest. 
 
In addition to these recordkeeping requirements, FDA recommends that 3P510k Review 
Organizations retain the following records for at least three years (3) following the submission of 
a 510(k) for review to FDA:   
 
29 
  Contains Nonbinding Recommendations 
 
(1) Copies of all 510(k) reviews and associated correspondence; 
 
(2) Information on the identity and qualifications of all personnel who contributed to the 
technical review of each 510(k); and  
 
(3) Other relevant records. 
 
In addressing the items enumerated above, 3P510k Review Organizations should be consistent 
with IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2): Requirements for Medical Device 
Auditing Organizations for Regulatory Authority Recognition87, including, but not limited to, 
records consistent with their quality management system, and  
IMDRF GRRP WG/N40 FINAL:2017: Competence, Training, and Conduct 
Requirements for Regulatory Reviewers.88 For more information on the IMDRF documents, see 
Section X of this guidance. 
  
In accordance with section 704(f)(1) of the FD&C Act, 3P510k Review Organizations must 
make the records specified in that section available upon request by an officer or employee of 
FDA. 3P510k Review Organizations shall permit the FDA officer or employee at all reasonable 
times to have access to, copy, and/or verify these records. Within 15 days of receipt of a written 
request from FDA, 3P510k Review Organizations must make copies of the requested records 
available at the place FDA designates (see section 704(f)(2) of the FD&C Act).  If FDAs 
monitoring of the 3P510k Review Program, such as a review of compensation arrangements 
between 3P510k Review Organizations and 510(k) Submitters, reveals that 510(k) Submitters 
are developing business relationships with 3P510k Review Organizations that call into question 
the independence or objectivity of a 3P510k Review Organization, FDA will consider limiting a 
Submitter's choice of 3P510k Review Organizations. Business relationships that may undermine 
the independence or objectivity of a 3P510k Review Organization include, for example, 
contracts between a manufacturer and a 3P510k Review Organization that represent a significant 
share of the 3P510k Review Organization's income.   
 
Section 523(b)(3)(F)(iv) requires 3P510k Review Organizations to agree that they will promptly 
respond and attempt to resolve complaints regarding its activities for which it is accredited. FDA 
recommends that 3P510k Review Organizations establish a recordkeeping system for tracking 
the submission of those complaints and how those complaints were resolved, or attempted to be 
resolved.   
 
VIII.  Content and Format of an Application for Initial 
Recognition and Rerecognition as a 3P510k Review 
Organization 
 
87 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition, previously cited, can be found at  
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
88 IMDRF GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers", previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
30 
  Contains Nonbinding Recommendations 
 
 
This section of the guidance provides FDAs recommendations on what should be included in an 
application to FDA for recognition as a 3P510k Review Organization. 
 
The 3P510k Review Organization should inform FDA promptly if they would like to suspend, 
withdraw, cancel or reduce the scope of their program. FDA will adjust recognition or 
rerecognition as appropriate.  
 
   Initial Recognition  
 
Organizations that wish to become recognized as 3P510k Review Organizations under section 
523 of the FD&C Act should send their applications to FDA at the following address. To 
facilitate review of the application, FDA strongly encourages submission of an eCopy.89  
 
CDRH Third Party Premarket Review Program 
U.S. Food and Drug Administration 
Document Control Center (DCC)  WO66-G609 
10903 New Hampshire Avenue, 
Silver Spring, Maryland 20993 USA. 
3P510K@fda.hhs.gov 
FDA will acknowledge receipt with an email to the applicants designated contact person when 
the application is received. FDA will review these materials and respond within 60 calendar 
days90 of the date of the receipt of the application with a decision to recognize or deny 
recognition, or a request for additional information. FDA may deem the application incomplete 
and deny recognition if the applicant fails to respond to FDAs request for additional information 
in a timely manner.   
 
To facilitate review, the following information should be submitted in an application for FDAs 
consideration: 
(1)  Administrative information 
a.  The name and mailing address of the 3P510k Review Organization seeking 
recognition; 
b.  The telephone number, email address, and fax number of the contact person. The 
contact person should be the person to whom questions about the content of the 
application may be addressed and the person to whom a letter of determination and 
general correspondence will be directed. Foreign organizations should also identify 
the name, address, telephone number, email address, and fax number of an authorized 
 
89 For information on the eCopy program, please see FDAs guidance entitled eCopy Program for Medical Device 
Submissions available on FDAs website at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/ecopy-program-medical-device-submissions. 
90 FDA uses calendar days when measuring on-time performance of user-fee supported premarket medical device 
submission reviews. See, MDUFA Performance Goals and Procedures, Fiscal Years 2018 through 2022 available 
on FDAs website at https://www.fda.gov/media/102699/download for more information.  
31 
  Contains Nonbinding Recommendations 
 
representative located within the United States that will serve as the 3P510k Review 
Organizations contact with FDA (see also Section VII.A of this guidance); 
c.  The name and title of the most responsible individual at the 3P510k Review 
Organization;   
d.  A brief description of the 3P510k Review Organization, including: type of 
organization (e.g., not-for-profit institution, commercial business, other type of 
organization); size of organization (number of employees); number of years in 
operation; nature of work (e.g., testing or certification laboratory); and information 
regarding ownership (i.e., name of owner(s) and extent of ownership), operation, 
control of organization, and other related information sufficient for FDA to assess its 
degree of independence from entities such as device manufacturers and distributors;  
e.  A listing of any national, state, local, or other recognition; and 
f.  A list of the device types the applicant seeks to review by product codes or 
classification regulation name and regulation. Please refer to the FDA Third Party 
public website91 for devices that are eligible for 3P510k review. 
   
 
91 Information on third party eligible device types is available on FDAs website: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm. 
32 
  Contains Nonbinding Recommendations 
 
(2)  Prevention of conflicts of interest  
 
A copy of the written policies and procedures established by the 3P510k Review Organization to 
ensure that the 3P510k Review Organization and its employees, external Technical Experts, 
contractors and individual contract employees involved in the evaluation of 510(k)s are free from 
conflicts of interest, and to prevent any individual or organizational conflict of interest, or 
appearance of conflict of interest that might affect the review process. 
(3)  Personnel qualifications 
 
A list of personnel who will be involved in the preparation of the 3P510k Review Organizations 
510(k) recommendations, including Product Specialists, Technical Experts, external Technical 
Experts, and Final Reviewers. Applicants should demonstrate that these personnel are technically 
competent to conduct 510(k) reviews and should document the following in their application: 
 
a.  The written policies and procedures established to ensure 510(k)s are reviewed by 
qualified personnel; 
 
b.  The written instructions for the duties and responsibilities of personnel with 
respect to 510(k) reviews; 
 
c.  The written personnel standards established to ensure that designated personnel 
are qualified in all of the scientific disciplines presented by the 510(k)s for 
devices for which the 3P510k Review Organization is applying for its review; 
 
d.  The documentation (e.g., curricula vitae or CVs) to establish that the reviewers of 
510(k)s (i.e., Product Specialists and Technical Experts) and other involved non-
supervisory personnel meet the Recognition Criteria for qualified personnel. This 
includes documentation of education, training, skills, abilities, and experience, 
including specialized education and experience needed for the review of devices 
for which the 3P510k Review Organization is applying for its review; 
 
e.  The documentation (e.g., CVs) to establish that the supervisor(s) of 510(k) 
reviewers (i.e., Final Reviewer) have sufficient authority and meet the 
Recognition Criteria for qualified supervisory personnel. This includes 
documentation of education, training, skills, abilities, and experience, including 
specialized education and experience needed for the review of class II devices for 
which the 3P510k Review Organization is applying for its review; and  
 
f.  A description of the management structure, or, if an external technical expert is 
used for 510(k) reviews, the external Technical Experts management structure.  
The application should describe the position of the individual(s) providing 
supervision within the management structure and explain how that structure 
provides for the supervision of 510(k) reviewers and other personnel involved in 
the review process. 
 
33 
  Contains Nonbinding Recommendations 
 
(4)  Certification statements 
 
As required by statute, and to support FDAs plan to eliminate routine re-review of 3P510k 
submissions,92 the applicant must provide a statement in their application, signed by the most 
responsible individual at the organization, certifying that the 3P510k Review Organization has 
committed at the time of accreditation and at any time it is performing any 3P510k review that it: 
 
a.  Will report information that accurately reflects data reviewed; 
 
b.  Will limit work and reviews to that for which competence and capacity are 
available, including conducting 510(k) reviews in accordance with the policies 
and procedures it has established regarding review of 510(k)s by qualified 
personnel; 
 
c.  Will treat any information, records, reports, and recommendations that they may 
receive as proprietary and confidential information;  
 
d.  Will promptly respond and attempt to resolve complaints regarding the activities 
for which it is recognized; 
 
e.  Will protect against conflicts of interests in accordance with policies and 
procedures it has established relating to prevention of financial conflicts of 
interests, and annually make available to the public disclosures of the extent to 
which the person, and the officers and employees of the person, have maintained 
compliance with requirements relating to financial conflicts of interest;  
 
FDA also encourages the applicant to certify in its application that at all times, it:  
 
a.  Will demonstrate conformity while recognized by FDA with the requirements of 
section 523 of the FD&C Act; 
 
b.  Will maintain records in a manner consistent with Section VII.G of this guidance; 
 
c.  Will comply with the eCopy requirements93 for premarket submissions as 
described in the guidance document entitled, eCopy Program for Medical Device 
Submissions, as discussed in Section VI.I  of this guidance;  
 
d.  Commits that their most responsible person or designee(s) will have completed 
FDA training prior to performing any reviews by the 3P510k Review 
Organization, and agrees that their most responsible person or designee(s) will 
attend such training when offered and applicable;  
 
 
92 See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews, available on FDAs website at 
https://www.fda.gov/media/116168/download. 
93 See section 745A(b) of the FD&C Act. 
34 
  Contains Nonbinding Recommendations 
 
e.  Will contact FDA for early interaction before reviewing any subset of device type 
(by respective product code) that they have not reviewed as encouraged in Section 
VI.D of this guidance; and  
 
f.  Will commit to only accepting reviews where the 510(k) Submitters certified that 
any relevant prior communications with FDA are disclosed. 
  Rerecognition 
 
In accordance with section 523(b)(2)(D) of the FD&C Act, a 3P510k Review Organizations 
recognition by FDA will sunset 3 years from the date the recognition was granted under section 
523 of the FD&C Act. To continue conducting 3P510k reviews beyond 3 years from the date of 
the last recognition or rerecognition, the 3P510k Review Organization must obtain rerecognition.  
 
Requests for rerecognition will be handled in the same manner as initial recognition requests.  
Accordingly, rerecognition applications should follow the format described in Section VIII.A of 
this guidance. For rerecognition, FDA may also consider the past premarket review performance 
of the 3P510k Review Organization and any information that comes to FDAs attention about the 
status of the 3P510k Review Organizations recognition, including information from an audit.94    
 
FDA recommends that 3P510k Review Organizations apply for rerecognition a minimum of 60 
calendar days before their recognition status expires to prevent any lapse in recognition. A 
3P510k Review Organization may request a rerecognition earlier if it so chooses. 
 
  Recognition or Rerecognition Denial 
 
A 3P510k Review Organization that wishes to request a reconsideration of a recognition denial 
or rerecognition denial may make a written request to FDA. For information about the appeals 
processes, please see FDAs guidance entitled Center for Devices and Radiological Health 
Appeals Processes.95 A written appeal should be submitted to the CDRH Ombudsman at: 
 
CDRH Ombudsman 
Center for Devices and Radiological Health 
Food and Drug Administration 
WO32 Room 4282 
10903 New Hampshire Avenue 
Silver Spring, Maryland 20993 USA 
 
 
94 See section 523(b)(2)(C) of the FD&C Act. 
95 Information on the appeals process for CDRH is available on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes and 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-
cdrh-appeals-processes-questions-and-answers-about-517. 
35 
  Contains Nonbinding Recommendations 
 
IX.  Suspension or Recognition Withdrawal 
 
Section 523(b)(2)(B) of the FD&C Act authorizes FDA to suspend or withdraw recognition of 
any 3P510k Review Organization, after providing notice and an opportunity for an informal 
hearing, when the 3P510k Review Organization is substantially not in compliance with the 
requirements of section 523 of the FD&C Act, poses a threat to public health or fails to act in a 
manner that is consistent with the purposes of section 523 of the FD&C Act.  
 
Under section 301(y)(1) of the FD&C Act, the following actions are prohibited by a 3P510k 
Review Organization: 
 
(1) Submission of a report or recommendation that is false or misleading in any material 
respect; 
 
(2) Disclosure of confidential information or any trade secrets without the express written 
consent of the person who submitted such information or secrets to the 3P510k Review 
Organization; and    
 
(3) Receipt of a bribe in any form or doing any corrupt act associated with a responsibility 
delegated to the 3P510k Review Organization under the FD&C Act.  
 
FDA will perform an assessment of each 3P510k Review Organization on a periodic (at least 
once every three years)96 or for cause basis as part of its auditing to ensure 3P510k Review 
Organizations continue to meet the standards of recognition (see section 523(b)(2)(C) of the 
FD&C Act). Generally, as resources allow, assessments will involve inspecting a 3P510k 
Review Organizations facility and/or records to ensure that the 3P510k Review Organization is 
operating in accordance with the procedures, qualifications, and certifications specified in the 
3P510k Review Organizations application and the FD&C Act.   
 
Furthermore, FDA will periodically evaluate completed premarket reviews of 510(k)s submitted 
to FDA under the 3P510k Review Program and will provide feedback to Product Specialists and 
the Final Reviewer of 3P510k Review Organizations following its audits.   
 
3P510k Review Organizations should continue to demonstrate technical competency to maintain 
recognition. If monitoring of a 3P510k Review Organization reveals nonconformity with section 
523, a threat to the public health, or a failure to act in a manner that is consistent with the 
purposes of section 523 of the FD&C Act, FDA may take steps to suspend or withdraw 
recognition of the 3P510k Review Organization, after providing notice and an opportunity for an 
informal hearing. See section 523(b)(2)(B) of the FD&C Act. 
 
 
 
96 See section 523(b)(2)(D)(i) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
 
X.  Leveraging the International Medical Device 
Regulators Forums (IMDRFs) documents  
 
In February 2011, the IMDRF was convened to discuss future directions in medical device 
regulatory harmonization. The IMDRF is a voluntary group of medical device regulators from 
around the world, including representatives from the FDA, who collaborate to build on the strong 
foundational work of the Global Harmonization Task Force on Medical Devices.  The purpose of 
the IMDRF is to accelerate international medical device regulatory convergence. 
 
The IMDRF Medical Device Single Audit Program (MDSAP) and Good Regulatory Review 
Practices (GRRP) working groups developed documents that provide the fundamental building 
blocks of a 3P510k program by providing criteria for reviewer competence, training, and 
conduct, and, for organizations, the recognition and monitoring of entities that perform 
regulatory audits and other related functions. Details are outlined in a collection of documents 
finalized from 2013 through 2019 and available on the IMDRF website.97   
 
There are many shared elements in FDAs statutory and regulatory criteria for 3P510k Review 
Organizations and IMDRF MDSAP WG/N3 FINAL: 2016 (Edition 2): Requirements for 
Medical Device Auditing Organizations for Regulatory Authority Recognition98 and IMDRF 
IMDRF GRRP WG/N40 FINAL:2017: Competence, Training, and Conduct 
Requirements for Regulatory Reviewers.99 These two documents focus on requirements of an 
auditing organization and of individuals performing regulatory reviews and other related 
functions under the respective medical device legislation, regulations, and procedures required in 
its regulatory jurisdiction. 
 
Due to these similarities, FDA believes that potential 3P510k Review Organizations in 
compliance with the GRRP and MDSAP documents, as appropriate, are likely to be in 
compliance with most FDA 3P510k Review Organization requirements and meet FDAs 
recommendations outlined in this guidance document. Such organizations do not necessarily 
need to generate new documentation for FDA, but rather can leverage existing documents in 
their applications to FDA and for ongoing recordkeeping.  
 
 
 
97 As of the publication of this guidance document, the IMDRF has published eight documents related to MDSAP 
and three documents related to GRRP. All the IMDRF documents are available on the IMDRF website 
at:http://imdrf.org/documents/documents.asp. This guidance references IMDRF GRRP WG N40 Final:2017, 
Competence, Training, and Conduct Requirements for Regulatory Reviewers, and IMDRF MDSAP WG N3 
Final:2016, Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition. 
98 IMDRF MDSAP Working Group N3 Final: 2016 (Edition 2): Requirements for Medical Device Auditing 
Organizations for Regulatory Authority Recognition, previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160324-requirements-auditing-orar.pdf. 
99 IMDRF/GRRP WG/N40 FINAL:2017: "Competence, Training, and Conduct 
Requirements for Regulatory Reviewers", previously cited, can be found at 
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf. 
37 
  Contains Nonbinding Recommendations 
 
XI.  Paperwork Reduction Act of 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).  
 
The time required to complete this information collection is estimated to be 24 hours to submit 
requests for accreditation, 24 hours to submit requests for reacceditation, 40 hours to submit 
510(k) reviews by 3P510k Review Organizations to FDA, and 15 minutes to submit complaints 
to FDA. In addition, the time required to complete this information collection with respect to 
recordkeeping is estimated to be 10 hours for maintaining records of 510(k) reviews and 1 hour 
for maintenance of Records regarding qualifications to receive FDA recognition as a 3PRO, and 
2 hours for maintenance of a recordkeeping system regarding complaints.  
 
Send comments regarding this burden estimate or suggestions for reducing this burden to:  
 
FDA PRA Staff, 
Office of Operations, 
Food and Drug Administration, 
PRAStaff@fda.hhs.gov 
 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  
The OMB control number for this information collection is 0910-0375 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov). 
 
 
 
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