Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
510(k) Third Party Review Program  
1 
and Third Party Emergency Use 
2 
Authorization (EUA) Review 
3 
Draft Guidance for Industry, 
4 
Food and Drug Administration Staff, 
5 
and Third Party 
6 
Review Organizations 
7 
8   
9  DRAFT GUIDANCE 
10   
11   
12  This draft guidance document is being distributed for comment purposes 
13  only. 
14   
15   
16  Document issued on December 21, 2023. 
17   
18   
19  You should submit comments and suggestions regarding this draft document within 60 days of 
20  publication in the Federal Register of the notice announcing the availability of the draft 
21  guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
22  comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, 
23  Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the docket 
24  number listed in the notice of availability that publishes in the Federal Register. 
25   
26  For questions about this document, contact ORP: Office of Regulatory Programs/DRP1: Division 
27  of Submission Support at 301-796-5640.  
28   
29   
30  When final, this guidance will supersede 510(k) Third Party Review 
31  Program; Guidance for Industry, Food and Drug Administration Staff, and 
32  Third Party Review Organizations issued on March 12, 2020. 
33   
34   
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35   
36   
37   
38  U.S. Department of Health and Human Services 
39  Food and Drug Administration 
40  Center for Devices and Radiological Health 
41   
 
42 
 
43 
   
44 
2 
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Preface 
45 
46   
47   
Additional Copies 
48 
49   
50  Additional copies are available from the Internet. You may also send an email request to CDRH-
51  Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
52  GUI01500013 and complete title of the guidance in the request. 
53   
54   
55   
56 
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Table of Contents
57   
58   
59  I.  Introduction ......................................................................................................................... 5 
60  II.  Background ......................................................................................................................... 7 
61    Basis for 3P510k Review Program ................................................................................ 7 
62    Basis for Third Party EUA Review ............................................................................... 8 
63    General Overview of 3P510k Review Program............................................................. 8 
64    General Overview of 3PEUA Review ......................................................................... 10 
65  III.  Scope ................................................................................................................................. 12 
66  IV.  Definitions......................................................................................................................... 12 
67  V.  Third Party Review of 510(k) Submissions and EUA Requests ...................................... 15 
68    Factors Used in Determining Device Type Eligibility in the 3P510k Review Program15 
69    Review of 510(k) Submissions or EUA Requests by Third Party Review Organizations
70   .................................................................................................................................. 17 
71  (1)  Determine device eligibility ................................................................................. 19 
72  (2)  Assign a Product Specialist(s), Final Reviewer, and Technical Expert(s) to conduct 
73  the substantive review of a submission ............................................................................ 20 
74  (3)  Obtain relevant FDA guidance(s) and information .............................................. 21 
75  (4)  Early Interaction with FDA .................................................................................. 22 
76  (5)  Ensure a submission is administratively complete ............................................... 24 
77  (6)  Conduct the substantive review of a submission .................................................. 25 
78  (7)  Identify deficiencies in a submission .................................................................... 26 
79  (8)  Document a review ............................................................................................... 27 
80  (9)  Organize and submit a submission including associated Third Party Review 
81  Organization review documentation ................................................................................ 28 
82  (10)  Submit additional information upon FDAs request ............................................ 31 
83  (11)  Submission dispute resolution .............................................................................. 32 
84    FDA Expectations of Third Party Review Organizations and for Recognition and 
85  Rerecognition of 3P510k Review Organizations ..................................................... 33 
86  (1)  Operational considerations ................................................................................... 34 
87  (2)  Management of impartiality ................................................................................. 34 
88  (3)  Personnel involved in reviewing activities ........................................................... 35 
89  (4)  Use of external Technical Experts ........................................................................ 37 
90  (5)  Confidential information ...................................................................................... 38 
91  (6)  Complaints regarding Submitters ......................................................................... 38 
92  (7)  Third Party Review Organization recordkeeping ................................................. 38 
93    Content and Format of an Application for Initial Recognition and Rerecognition as a 
94  3P510k Review Organization ................................................................................... 40 
95  (1)  Initial Recognition ................................................................................................ 40 
96  (2)  Rerecognition........................................................................................................ 43 
97  (3)  Recognition or Rerecognition Denial ................................................................... 44 
98    Suspension or Recognition Withdrawal....................................................................... 44 
99    Leveraging the International Medical Device Regulators Forums (IMDRFs) documents
100   .................................................................................................................................. 45 
101     
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510(k) Third Party Review Program 
102 
and Third Party Emergency Use 
103 
Authorization (EUA) Review 
104 
Draft Guidance for Industry,  
105 
Food and Drug Administration Staff, 
106 
and Third Party Review Organizations 
107 
108   
109  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
110  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
111  and is not binding on FDA or the public.  You can use an alternative approach if it satisfies 
112  the requirements of the applicable statutes and regulations.  To discuss an alternative 
113  approach, contact the FDA staff or Office responsible for this guidance as listed on the title 
114  page.  
115   
116  I.  Introduction 
117   
118  The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons 
119  (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic Act 
120  (FD&C Act).1 Under the authority in section 523 of the FD&C Act, FDA recognizes third parties 
121  to review premarket notification (510(k)) submissions and recommend the initial classification 
122  of certain devices.2 FDAs implementation of section 523 of the FD&C Act establishes a process 
 
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) Good Regulatory Review Practices (GRRP) documents and are defined in 
Section IV of this guidance.   
2 Section 201(h)(1) of the FD&C Act provides that the term device is defined as follows:  
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related  
article, including any component, part, or accessory, which is-- 
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to  
them,  
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or  
prevention of disease, in man or other animals, or  
 
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123  for recognition of qualified third parties to conduct the initial review of 510(k) submissions for 
124  certain low-to-moderate risk devices eligible for review under the 3P510k Review Program 
125  within the Center for Devices and Radiological Health (CDRH) that are submitted directly to a 
126  3P510k Review Organization (3P510k RO).3  
127   
128  FDA may contract with third party review organizations to perform reviews of Emergency Use 
129  Authorization (EUA) requests (3PEUA review) when appropriate emergency declaration 
130  authorities are active under section 564 of the FD&C Act. FDA has previously contracted with 
131  third party review organizations to perform reviews for 3PEUA review when appropriate 
132  emergency declaration authorities are active under section 564 of the FD&C Act.   
133   
134  For the current edition of the FDA-recognized standards referenced in this document, see the 
135  FDA Recognized Consensus Standards Database.4 For more information regarding use of 
136  consensus standards in regulatory submissions, please refer to the guidance Appropriate Use of 
137  Voluntary Consensus Standards in Premarket Submissions for Medical Devices.5 
138   
139  The objectives of this guidance are:  
140   
141    To describe and distinguish FDAs expectations for the 3P510k Review Program and for 
142  3PEUA review; 
143    To describe the factors FDA will use in determining device type eligibility for review by 
144  3P510k ROs; 
145    To outline FDAs process for the recognition, rerecognition, suspension, and withdrawal 
146  of recognition for 3P510k ROs;  
147    To clarify FDAs expectations for review under both 3P510k review and 3PEUA review 
148  for all stakeholders to ensure confidence and consistent quality of work by Third Party 
149  Review Organizations6 to eliminate the need for routine, substantive re-review by FDA;7 
150    To outline FDAs expectations to prevent conflicts of interest between the Third Party 
151  Review Organization(s) and other entities; and 
152    To describe FDAs expectations regarding the compensation process between the Third 
153  Party Review Organization(s) and other entities. 
154   
 
(C) intended to affect the structure or any function of the body of man or other animals, and which does not 
achieve its primary intended purposes through chemical action within or on the body of man or other animals and 
which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term 
device does not include software functions excluded pursuant to section 520(o) of the FD&C Act. 
3 Devices of the types eligible for 3P510(k) review are not currently being reviewed in the Center for Biologics 
Evaluation and Research. 
4 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
6 As described in Section IV of this guidance, the use of Third Party Review Organizations indicates an 
expectation for both 3P510k and 3PEUA ROs.  
7 See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews, available at 
https://www.fda.gov/media/116168/download 
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155  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
156  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
157  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
158  the word should in Agency guidances means that something is suggested or recommended, but 
159  not required.  
160  II.  Background 
161    Basis for 3P510k Review Program 
162   
163  On August 1, 1996, FDA launched a voluntary third party 510(k) review pilot program for 
164  selected medical devices. Under this pilot program, all class I devices that were not 510(k) 
165  exempt at that time, and 30 class II devices were eligible for 3P510k review.  
166   
167  On November 21, 1997, the Food and Drug Administration Modernization Act (FDAMA)8 was 
168  signed into law. Section 210 of FDAMA codified and expanded the pilot program by 
169  establishing section 523 of the FD&C Act.  
170   
171  On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA)9 was 
172  signed into law and required FDA to establish and publish criteria to accredit, reaccredit, and 
173  deny reaccreditation of 3P510k ROs that perform 510(k) reviews of eligible devices.     
174   
175  On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA)10 was signed into law and 
176  required FDA to issue guidance on the factors FDA will use in determining whether a class I or 
177  class II device type, or subset of such device types, is eligible for review by 3P510k ROs, 
178  including the risk of the device type and whether the device type is permanently implantable, life 
179  sustaining, or life supporting, and whether there is a detailed public health justification for 
180  permitting the review by an accredited person of such device type. This guidance also addresses 
181  several Medical Device User Fee Amendments (MDUFA) IV11 and V12 commitments by 
182  including an early interaction (EI) consult policy; clarifying criteria for rerecognition of 3P510k 
183  ROs and the suspension or withdrawal of recognition; encouraging thorough review memoranda 
184  to reduce the need for FDA re-review; and discussing how FDA will audit the 3P510k Review 
185  Program as part of ongoing audit plans under the Quality Management and Organizational 
186  Excellence (QMOE) Program.  
 
8 Pub. L. 105-115. 
9 Pub. L. 112-144. 
10 Pub. L. 115-52. 
11 Through the MDUFA IV Commitment Letter, FDA commits to improving the Third Party 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  
12 As described in Section V.D. of the MDUFA V Commitment Letter, FDA will continue to support the Third Party 
Review program, with the objective of eliminating routine re-review by FDA of Third Party reviews: See 168 
CONG. REC. S5195-S5200 (daily ed. September 28, 2022) (Food and Drug Administration User Fee 
Reauthorization), also available at https://www.fda.gov/media/158308/download 
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187   
188    Basis for Third Party EUA Review 
189   
190  In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. The virus has 
191  been named SARS-CoV-2, and the disease it causes has been named Coronavirus Disease 
192  2019 (COVID-19). The COVID-19 pandemic presented FDA with an unprecedented workload 
193  across many device areas, including and perhaps especially, in vitro diagnostics to detect SARS-
194  CoV-2. In response to the COVID-19 pandemic, an unprecedented number of manufacturers 
195  came forward to request EUAs for in vitro diagnostic products for detection of SARS-CoV-2. 
196  The manufacturers included those familiar and unfamiliar with FDA regulation. As scientific 
197  understanding advanced, FDA was able to offer templates to developers outlining FDAs 
198  expectations for the development of prescription tests for SARS-CoV-2 across different 
199  technologies, including molecular, antigen, and serology tests. As the number of tests that were 
200  issued EUAs related to COVID-19 grew to meet demand, FDA focused on reviewing EUA 
201  requests for tests with new intended uses, such as over-the-counter tests for home use. At the 
202  same time, FDA continued to receive a large volume of EUA requests for tests with intended 
203  uses and technologies with which FDA had performed sufficient reviews such that it generally 
204  understood the information needed to support such an EUA request. Consequently, FDA 
205  contracted with a 3PEUA Review Organization (3PEUA RO) to review and provide 
206  recommendations on over one hundred in vitro diagnostic device EUA requests.   
207   
208  On December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New 
209  Threats, and Pandemics Act (PREVENT Pandemics Act) was signed into law as part of the 
210  Consolidated Appropriations Act, 2023 (hereafter referred to as the FY 2023 Omnibus).13 
211  Section 2502 of the FY 2023 Omnibus amends section 565 of the FD&C Act to add subsection 
212  (i), which clarifies FDAs authority regarding use of third party review organizations to conduct 
213  initial reviews of EUA requests for in vitro diagnostic products. It further directs FDA to issue 
214  guidance on such third party review, including considerations on compensation, information 
215  sharing, and conflicts of interest. This guidance update is intended to satisfy FDAs obligation to 
216  issue draft guidance on consultations with persons under section 565(i) of the FD&C Act and to 
217  provide clarity on use of 3PEUA review for devices other than in vitro diagnostic products. 
218  When final, it will provide FDAs current thinking on 3PEUA review.    
219   
220    General Overview of 3P510k Review Program 
221   
222  The 3P510k Review Program is intended to support FDAs mission to protect and promote 
223  public health by enabling the Agency to focus its internal scientific review resources on higher-
224  risk and complex devices, while maintaining a high degree of confidence in the review of low-to-
225  moderate risk and less complex devices by 3P510k ROs, and to provide manufacturers of 
 
13 See Pub. L. No. 117-328, available at https://www.congress.gov/bill/117th-congress/senate-bill/3799/text#toc-
id4337B43372204E669A25EB3B18C8F11F  
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226  eligible devices a voluntary alternative review process that may yield more rapid decisions on 
227  510(k)s.14 Figure 1 below provides a schematic overview of the 3P510k Review Program.15 
228   
229  Figure 1  A General Overview of the 3P510k Review Program 
510(k) Submitter  Submission 
sends submission  review is 
to O3Prg5a1n0ikz aRteiovniew  3P510k Review  3OP5rg1a0nki zRaetvioienw   FDA reviews  FDA informs  3OP5rg1a0nki zRaetvioienw   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
230  FDA  
231   
232  Under the 3P510k Review Program, 3P510k ROs review a 510(k) submission and then forward 
233  their review, the 510(k) submission, and a recommendation to FDA (i.e., substantially equivalent 
234  (SE) or not substantially equivalent (NSE) as defined under section 513(i) of the FD&C Act) as 
235  described in more detail in Section VI.B.(6) of this guidance. FDA reviews the 3P510k ROs 
236  memo and recommendation and makes a final decision on the submission. Section 523(a)(2) of 
237  the FD&C Act requires FDA to make a determination with respect to the initial classification 
238  within 30 calendar days16 after receiving a recommendation from a 3P510k RO. In this pathway, 
239  the 510(k) Submitter pays the 3P510k RO directly; no user fee is due to FDA for the 510(k) 
240  reviewed by the 3P510k RO.17 A general principle of the 3P510k Review Program is that the 
241  3P510k RO is the conduit for communication to and from the 510(k) Submitter and to and from 
242  the FDA. This ensures the 3P510k RO is fully informed and that communications between FDA 
243  and the 510(k) submitter do not undermine the role of the 3P510k RO.   
244   
245  A 3P510k RO must be recognized by FDA under section 523(b) of the FD&C Act to be eligible 
246  to participate in the 3P510k Review Program. FDA recognizes 3P510k ROs18 to review 510(k)s 
247  for certain device types eligible for the 3P510k Review Program.19   
248     
249  Participation by 510(k) Submitters in the 3P510k Review Program is voluntary. Manufacturers 
250  who do not wish to use a 3P510k RO may submit their 510(k)s directly to the FDA for review, 
 
14 See section 523(a)(3) of the FD&C Act. 
15 Figure 1 uses IEC/IEC 19510: Information technology  Object Management Group Business Process Model and 
Notation (2013).  
16 FDA uses calendar days when measuring on-time performance of user-fee supported premarket medical device 
submission reviews. For more information, see MDUFA Performance Goals and Procedures, Fiscal Years 2023 
through 2027, available at https://www.fda.gov/media/158308/download 
17 See section 738(a)(2)(B)(iv) of the FD&C Act. 
18 A current list of recognized 3P510k ROs is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/Accredit.cfm 
19 A current list of eligible devices for review under the 3P510k Review Program is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
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251  through either the Traditional, Special, or Abbreviated Programs, as appropriate, and pay the 
252  appropriate FDA user fee.20, 21, 22  
253   
254  As described in this guidance, the 3P510k Review Program includes features designed to ensure 
255  a high level of quality in the review of 510(k)s by a 3P510k RO and to minimize risks to public 
256  health. In evaluating a 3P510k RO for recognition or rerecognition, FDA will consider not only 
257  the application, as outlined in Section V.D of this guidance, but may also consider past 
258  premarket review performance of the 3P510k RO as described in Section V.D.(2) of this 
259  guidance.23   
260   
261    General Overview of 3PEUA Review  
262   
263  3PEUA review is intended to support FDAs mission to protect and promote public health by 
264  enabling the Agency to surge or rapidly expand its resources for reviewing EUA requests 
265  relating to medical devices. Under section 564 of the FD&C Act, FDA may, after the Secretary 
266  of Health and Human Services (HHS) has made a declaration of emergency or threat justifying 
267  authorization of emergency use (an EUA declaration), authorize the emergency use of an 
268  unapproved product24 or an unapproved use of an approved product for certain emergency 
269  circumstances. FDA may issue an EUA to allow a product to be used to diagnose, treat, or 
270  prevent a serious or life-threatening disease or condition referenced in the EUA declaration, 
271  when certain statutory criteria are met, including FDAs determination under section 564(c)(2)  
272  of the FD&C Act that, based on the totality of scientific evidence, the product may be effective 
273  for such use, the known and potential benefits outweigh the known and potential risks for such 
274  use, and, under section 564(c)(3) of the FD&C Act, that there are no adequate, approved, and 
275  available alternatives.25  
276   
277  To assist FDA in reviewing EUA requests in a timely manner, FDA may establish a contractual 
278  relationship with one or more qualified 3PEUA ROs to conduct such reviews. In general, FDA 
279  intends for EUA requests to be submitted directly to FDA. and FDA may, at our discretion, then 
 
20 See the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k 
21 See the guidance The Abbreviated 510(k) Program, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/abbreviated-510k-program 
22 See the guidance The Special 510(k) Program, available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/special-510k-program 
23 See sections 523(b)(2) and 523(b)(3) of the FD&C Act. 
24 For purposes of this document, the term unapproved product refers to a product that is not approved, licensed, or 
cleared under section 505, 510(k), 513 or 515 of the FD&C Act; an unapproved use of an approved product refers 
to a product that is approved, licensed, or cleared under such a provision but for which the specific use is not an 
approved, licensed, or cleared use of the product. See unapproved product and unapproved use of an approved 
product in section 564(a)(2) of the FD&C Act. 
25 For more information on FDAs emergency use authorities under section 564 of the FD&C Act, see the guidance 
Emergency Use Authorization of Medical Products and Related Authorities, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-
products-and-related-authorities    
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280  forward the EUA request to 3PEUA ROs, as appropriate.26 The 3PEUA RO should work with 
281  the submitter to address any deficiencies identified by the 3PEUA RO, document its review, and 
282  forward its recommendation to FDA in writing. FDA will conduct the final review and may issue 
283  an EUA, as appropriate. More specifically, FDA will  consider recommendations from 3PEUA 
284  ROs related to whether the standard under section 564(c)(2) of the FD&C Act is met, as well as 
285  recommendations pertaining to the scope of authorization under section 564(d) of the FD&C Act 
286  and conditions of authorization under section 564(e) of the FD&C Act. FDA does not intend to 
287  consider recommendations from 3PEUA ROs relating to other criteria for issuance of an EUA, 
288  such as whether there are adequate, approved, and available alternatives. Typically, FDA will 
289  likely have more information on these issues than the 3PEUA RO. Figure 2 below provides an 
290  overview of 3PEUA review.27 
291   
292  Accurate and reliable diagnostic tests are critical to the tracking, treatment, and suppression of 
293  transmission during an emergency. In order to respond quickly and increase access in certain 
294  emergency situations, for in vitro diagnostic products,28 FDA may determine that public health 
295  would be better served by having submitters send certain EUA requests for in vitro diagnostic 
296  products directly to a 3PEUA RO. In such case, FDA plans to include information on the public 
297  website regarding submission of EUA requests directly to specified 3PEUA ROs. Relevant in 
298  vitro diagnostic product codes and other device specifics (e.g., specimen type, use setting) will 
299  also be listed on that website.29 The same review process is intended to apply for EUA requests 
300  sent directly to a 3PEUA RO. 
301   
302  Note that for review of EUA requests, FDA may contract with 3PEUA ROs when appropriate 
303  emergency declaration authorities are active under section 564 of the FD&C Act. Given that the 
304  needs of an EUA declaration and the scientific expertise appropriate to reviewing EUA 
305  submissions will typically not be known prior to an emergency, FDA does not anticipate 
306  identifying potential 3PEUA ROs in advance. The terms of a contract between FDA and a 
307  3PEUA RO will control over this guidance.  
308   
309  Figure 2  A General Overview of 3PEUA Review 
EUA Submitter 
submits  3PEUA review  3PEUA review 
FDA reviews and 
request to FDA FDA determines  organization  organization 
informs 3PEUA  FDA issues 
3P appropriate  conducts review,  documents and 
review  authorization letter 
and sends to  interacting with  sends 
organization of  if appropriate 
3PEUA reviewer sponsor to address  recommendation  Review
decision
deficiencies to FDA Complete
310   
311   
 
26 FDA generally intends to contract with 3PEUA ROs when there are, or are anticipated to be, a large volume of 
EUA requests or certain types of EUA requests and, based on the circumstances of an emergency, the Agency 
determines that help with review would be beneficial. 
27 Figure 2 uses IEC/IEC 19510: Information technology  Object Management Group Business Process Model and 
Notation (2013).  
28 See 21 CFR 809.3. 
29 For a list of relevant devices for 3PEUA review, please visit FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
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312  3PEUA review differs from the 3P510k Review Program in several ways. Some of the main 
313  differences are:  
314   
315    3PEUA review may only occur following a relevant declaration under section 564 of 
316  the FD&C Act justifying emergency use authorization of a product. Assignment of a 
317  EUA request will be determined at FDAs discretion. 
318    EUA Submitters should send EUA requests directly to FDA, and FDA may decide to 
319  send certain EUA requests to a 3PEUA RO for review. For in vitro diagnostic 
320  products, FDA may determine that the public health would be better served by having 
321  submitters send EUA requests directly to a 3PEUA RO.   
322    FDA may contract with 3PEUA ROs directly. This includes the review of EUA 
323  requests for in vitro diagnostic products where FDA determines it would be 
324  appropriate to send EUA requests directly to a 3PEUA RO. 
325   
326  Section V of this guidance clarifies FDAs expectations for the 3P510k Review Program and for 
327  3PEUA review, as applicable. As noted in Section IV of this guidance, references to Third Party 
328  Review Organization indicate an expectation for both 3P510k ROs and 3PEUA ROs. 
329  III.  Scope 
330   
331  This guidance outlines FDAs current thinking on key aspects of the 3P510k Review Program 
332  and 3PEUA review, including:  
333   
334    Factors used to establish device type eligibility in the 3P510k Review Program (see 
335  Section V.A); 
336    FDAs expectations for third party reviews of 510(k) and EUA submissions, including 
337  the policy for EI consults on 3P510k submissions (see Section V.B); 
338    Requirements and considerations for recognition and rerecognition of 3P510k ROs under 
339  the 3P510k Review Program (see Section V.C); 
340    Content and format of a 3P510k ROs application for initial recognition and rerecognition 
341  (see Section V.D); 
342    Process for suspension or withdrawal of recognition for 3P510k ROs (see Section V.E); 
343  and 
344    Leveraging the International Medical Device Regulators Forums (IMDRFs) 
345  requirements for Regulatory Reviewers under the Good Regulatory Review Practices 
346  (GRRP), as appropriate (see Section V.F). 
347  IV.  Definitions  
348   
349  The definitions provided below explain the terms used by FDA in the context of this guidance. 
350  These terms are not intended to be applied in any context beyond this document, the 3P510k 
351  Review Program, and 3PEUA review. 
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352  Device Type: A device type or category as set forth in a section of the Code of Federal 
353  Regulations, as well as a subset of such device type, such as that set forth in a product code. 
354  EUA Submitter: An entity or person that submits a request for Emergency Use Authorization 
355  under section 564 of the FD&C Act.   
356  510(k) Submitter: An entity or person that submits a 510(k) submission to a 3P510k Review 
357  Organization for the purposes of demonstrating substantial equivalence (SE) of that device to a 
358  legally marketed device that is not subject to premarket approval (PMA).  
359  Final Reviewer: An individual within the Third Party Review Organization who oversees the 
360  review of a 510(k) submission or EUA request throughout the entire review process. The Final 
361  Reviewer is a regulatory reviewer who meets the criteria of an IMDRF Regulatory Reviewer 
362  (defined below) and who is responsible for ensuring that final recommendations regarding the 
363  device made by the Product Specialist (defined separately) are appropriately evaluated, 
364  organized, and documented before documents are sent to FDA. This individual has sufficient 
365  authority and competence within the Third Party Review Organization to independently evaluate 
366  the quality and acceptability of the Third Party review documentation. The Final Reviewer is a 
367  separate individual from the Product Specialist. 
368   
369  IMDRF Regulatory Reviewer: An individual meeting and fulfilling the competencies, 
370  commitments, training, and conduct described in IMDRF/GRRP WG/N40 FINAL:2017  
371  Competence, Training, and Conduct Requirements for Regulatory Reviewers30 produced by 
372  IMDRF. This is IMDRFs Good Regulatory Review Practices (GRRP) document describing 
373  criteria for individuals who perform regulatory reviews of medical devices for marketing 
374  authorization, whether those individuals work for governmental regulatory authorities or 
375  Conformity Assessment Bodies (CABs)31 that FDA believes 3P510k ROs and 3PEUA ROs 
376  should follow, where applicable, and to the extent such criteria are appropriate and consistent 
377  with the FD&C Act and other applicable laws and regulations.   
378   
379  Product Specialist: An individual within a Third Party Review Organization, who meets the 
380  criteria of an IMDRF Regulatory Reviewer (defined above), and is qualified to review and 
381  evaluate medical devices within specific device type(s), who may also be qualified for a specific 
382  technical or clinical specialization (e.g., biocompatibility and sterilization), based on their 
383  scientific background and competence. This individual is the primary reviewer responsible for 
384  leading the organizations review team on a given 510(k) submission or EUA request. The 
385  Product Specialist submits their recommendation and all related documentation to the Final 
386  Reviewer.  
387   
 
30 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 
31 Conformity Assessment Body (CAB): A body other than a Regulatory Authority engaged in determining whether 
the relevant requirements in technical regulations or standards are fulfilled (GHTF/SG1/N78:2012), IMDRF/GRRP 
WG/N40FINAL:2017, section 3.6.    
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388  Recognition: The process of accrediting 3P510k Review Organizations under section 523 of the 
389  FD&C Act to review premarket notifications submitted under section 510(k) of the FD&C Act of 
390  certain eligible devices and make recommendations to FDA regarding the initial classification of 
391  such devices under section 513(f)(1) of the FD&C Act. 
392   
393  Rerecognition: The process of renewing the accreditation of 3P510k Review Organizations 
394  under section 523 of the FD&C Act. Unless suspended or withdrawn, accreditation is valid for 
395  three years.32  
396   
397  Recognition Criteria: The applicable FD&C Act requirements, including the qualification 
398  requirements set forth in section 523(b)(3) of the FD&C Act; FDAs recommendations described 
399  in this guidance document, including those criteria contained in IMDRF GRRP WG N59 
400  Final:2020 Requirements for Regulatory Authority Recognition of Conformity Assessment 
401  Bodies Conducting Medical Device Regulatory Reviews, where appropriate and applicable) and 
402  IMDRF GRRP WG N40;33 and the criteria to accredit or deny accreditation announced in the 
403  Federal Register.34  
404   
405  Recognition Denial: The process of denying an application for accreditation submitted by a 
406  potential 3P510k Review Organization. 
407   
408  Rerecognition Denial: The process of denying an application for reaccreditation submitted by a 
409  recognized 3P510k Review Organization. 
410   
411  Recognition Withdrawal: The process of withdrawing or suspending accreditation of a 3P510k 
412  Review Organization in accordance with section 523(b)(2) of the FD&C Act. 
413   
414  Safety Signal: A signal that represents a new potentially causal association or a new aspect of a 
415  known association between a medical device and an adverse event or set of adverse events.35 
416   
417  Submission: As used in this document, submission refers to either a 510(k) submission or an 
418  EUA request.  
419   
420  Technical Expert: An individual who provides specific knowledge or expertise. This individual 
421  may be an employee of a 3P510k Review Organization or 3PEUA Review Organization or may 
422  be external as described below in Sections V.B.(2) and V.C.(4) of this guidance, respectively. 
423   
 
32 See section 523(b)(2)(D) of the FD&C Act. 
33 IMDRF/GRRP WG/N40 Final:2017: Competence, Training, and Conduct Requirements for Regulatory 
Reviewers, previously cited, available at http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-
competence-conduct-reviewers.pdf 
34 Medical Devices; Implementation of Third Party Review Under the Food and Drug Administration 
Modernization Act of 1997; Emergency Processing Request Under OMB Review, 63 FR 28388, May 22, 1998, 
available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf 
35 See Signal Management Program in Medical Device Safety Action Plan: Protecting Patients, Promoting Public 
Health, available at https://www.fda.gov/media/112497/download 
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424  Third Party 510(k) (3P510k) Review Organization (3P510k RO): An organization recognized 
425  by FDA to review 510(k) submissions for certain eligible devices as authorized by section 523 of 
426  the FD&C Act. 
427   
428  Third Party EUA (3PEUA) Review Organization (3PEUA RO): An organization under 
429  contract with FDA to review EUA requests.   
430   
431  Third Party Review Organization: This phrase refers to either an 3PEUA Review Organization 
432  or a 3P510k Review Organization.   
433   
434  V.  Third Party Review of 510(k) Submissions and EUA 
Requests 
435 
436    Factors Used in Determining Device Type Eligibility in 
437  the 3P510k Review Program  
438   
439  The factors FDA considers in determining device type eligibility for the 3P510k Review 
440  Program are as follows: 
441   
442    The risk of the device type, or subset of such device type.36 FDA generally classifies 
443  medical devices based on risks associated with the device type and whether general 
444  controls are sufficient to provide a reasonable assurance of the safety and effectiveness of 
445  the device or there is sufficient information to establish special controls to mitigate such 
446  risks and provide such assurance. Devices are classified into one of three regulatory 
447  classes: class I, class II, or class III.37 In accordance with the statute, class III devices are 
448  not eligible for 3P510k review.38  
449    Whether the device type, or subset of such device type, is intended to be permanently 
450  implanted in the human body, to sustain human life, or to support human life. Any 
451  3P510k RO seeking recognition for review of such device types must provide a detailed 
452  public health justification explaining why this device type should be eligible for 3P510k 
453  review39 and how this will positively impact public health.  
454    The extent to which the device type is well understood. For example, devices with novel 
455  technological characteristics, including some devices requiring complex special controls 
456  initially classified through the De Novo process may be ineligible for 3P510k review.40  
 
36 See section 523(a)(3)(B)(i)(I) of the FD&C Act. 
37 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 
38 See section 523(a)(3)(A)(i) of the FD&C Act. 
39 See section 523(a)(3)(B)(i)(II) of the FD&C Act. 
40 See De Novo Classification Process (Evaluation of Automatic Class III Designation), available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-
evaluation-automatic-class-iii-designation 
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457    The extent to which necessary information to make a well-informed recommendation is 
458  available to 3P510k ROs. If information materially relevant to evaluating a device type 
459  cannot be shared outside the agency (e.g., it is proprietary), the device type may be 
460  ineligible for 3P510k review.  
461    The extent to which the review of the device type does not require multifaceted, 
462  interdisciplinary expertise. The following are examples of scenarios that would likely be 
463  ineligible for 3P510k review due to the need for such expertise:  
464    The review of some kinds of clinical data or complex non-clinical data (e.g., 
o
465  computational modeling);   
466    A need for consultation across different FDA organizational components, or in 
o
467  cross-modality topics (e.g., a multi-reader clinical study);  
468    A combination product or device type either of which requires review from 
o
469  another Center in the Agency; and 41  
470    If a device type raises novel cross-labeling considerations, such as the potential 
o
471  for off-label use of drugs (e.g., injector needles or syringes). Cross-labeled 
472  products usually refer to any drug, device, or biological product packaged 
473  separately that, according to its proposed labeling, is for use only with another 
474  individually specified drug, device, or biological product where both are required 
475  to achieve the intended use, indication, or effect.42  
476    However, if a device type contains simple clinical data such as sample clinical 
o
477  images or tests using banked specimens, it may be eligible for 3P510k review. 
478  Most in vitro diagnostic products are eligible for 3P510k review as they typically 
479  rely on simple clinical studies to demonstrate SE, provided that such devices also 
480  meet the other factors listed in this section. 
481    The availability of postmarket data suggesting that the device type is the subject of safety 
482  signals. For example, if a device type is the subject of a safety communication, a high-
483  risk recall (Class I)43, or postmarket data that indicate a safety signal, this device type 
484  may be ineligible for 3P510k review.  
485  For example, duodenoscopes have a safety signal associated with their reprocessing.44 
486  Because of this safety signal, FDA removed duodenoscopes and accessories from 
487  eligibility for the 3P510k Review Program.    
488   
489  FDA will consider each of the above factors in determining device type eligibility for 3P510k 
490  review. Furthermore, if a device type is considered eligible for 3P510k review, but a proposed 
 
41 For more information on combination products, please visit Frequently Asked Questions About Combination 
Products, available at https://www.fda.gov/combination-products/about-combination-products/frequently-asked-
questions-about-combination-products  
42 See the guidance In Vitro Companion Diagnostic Devices, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/vitro-companion-diagnostic-devices    
43 For more information on classification of recalls, please visit Recalls, Corrections and Removals (Devices), 
available at https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-
removals-devices 
44 Information on safety signals associated with duodenoscopes is available at https://www.fda.gov/medical-
devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes 
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491  modification to the device type for a specific submission raises different concerns related to the 
492  factors listed above, upon receipt of completed review by a 3P510k RO or through the EI request 
493  process outline in Section V.B.(4) of this guidance, FDA may determine that a submission is 
494  ineligible for 3P510k review. 
495    
496  If a submitter has previously submitted a 510(k) for a device that resulted in anything other than 
497  an SE decision (e.g., withdrew after receiving FDA feedback or was NSE), then that device is 
498  not eligible for the 3P510k pathway for that submitter.45 
499   
500  The product code classification database46 and FDAs list of devices eligible for 3P510k 
501  review47 were updated to reflect these eligibility factors to determine 3P510k eligibility for 
502  device types. If eligible device types are determined to be ineligible for 3P510k review, or 
503  ineligible ones are determined to be eligible for 3P510k review, FDA will change their status in 
504  the database and FDAs publicly available list. FDA will periodically review new device types 
505  using the factors described above to determine whether they are appropriate for 3P510k review, 
506  and update the database and list accordingly.     
507    Review of 510(k) Submissions or EUA Requests by Third 
508  Party Review Organizations 
509   
510  FDA believes that Third Party Review Organizations should conduct FDA-equivalent reviews of 
511  appropriate devices. Third Party Review Organizations are responsible for reviewing and 
512  analyzing scientific and technical data in a submission to make a recommendation to FDA 
513  regarding the device. Third Party Review Organizations should conduct their review of 
514  submissions in the manner described in the sections below and in accordance with their own 
515  quality control practices. Figure 3 identifies the key steps in a 3P510k ROs review of a 510(k) 
516  submission,48 while Figure 4 identifies the key steps in a 3PEUA ROs review of an EUA 
517  request.  
518   
519   
520   
521   
522   
523   
524   
525   
526   
 
45 See section 523(a)(3)(B)(iii) of the FD&C Act.  
46 The product code classification database is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm 
47 A current list of eligible devices for 3P510k review is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
48 Figure 3 uses IEC/IEC 19510: Information technology  Object Management Group Business Process Model and 
Notation (2013). 
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527  Figure 3: Steps in a 3P510k Review Organizations 510(k) Review 
3P510k Review 
Organization 
refuses to accept 
3P510k Review  file for review Obtain early 
Organization  interaction 
receives  consult 
submission from  No (as needed)
510(k) Submitter Assign a Product 
Obtain 
Determine  Is the  Yes Specialist, a Final 
guidance and 
Device  device  Reviewer, and, if 
relevant 
Eligibility eligible? necessary, a 
Technical Expert information Ensure 
submission is 
complete
Final Reviewer 
Conduct &  Document the 
document  Is additional  No review and  conducts Final 
Review to 
substantive  info needed? Organize the 
finalize the 
review Submission Final ERnedviewer 
Submission
submits 
Yes recommendation 
and submission 
to FDA
Receive additional Request additional 
 information information
 from 510(k) submitter from 510(k) submitter
                
528                
529   
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530  Figure 4: Steps in Establishing and Conducting EUA Review by a 3PEUA Review 
531  Organization  
Section 564 
Authority 
FDA 
Granted FDA 
FDA solicits  FDA and  determines 
determines a  
organizations  3PEUA RO  which EUA 
need for 
for potential  establish  requests are a 
3PEUA Review 
3PEUA review contract fit for 3PEUA  FDA forwards EUA 
exists
Review Request(s) to 3PEUA 
RO
Clarify issues 
3PEUA Review Assign a  by interacting 
Organization  with requestor 
Product 
Receives 3PEUA  as needed
Confirm  Specialist, a 
Request Conduct & 
Request  Final  Obtain latest 
document 
within  Reviewer,   Guidance and 
substantive 
Contract  and, if  Templates
review
Scope necessary, a 
Clarify issues 
Technical 
by interacting 
Expert
with FDA as 
needed
Contact FDA if needed
Final Reviewer 
conducts Final 
Document the 
Review to 
review and 
finalize the 
Draft 
Review 
appropriate 
Products and  Send 2 Sets of Documents 
letter
Recommend-  to FDA
E.g., Authorization,  ation for final review
additional  and to determine 
information, or  final action
decline to issue
532              
533  (1)  Determine device eligibility  
534   
535  Before reviewing a 510(k) submission, a 3P510k RO should determine whether they have the 
536  expertise to review the device type and whether that device type is eligible for 3P510k review 
537  based on review of the product code classification database49 or the FDA Third Party Review 
538  public website.50 If the 3P510k RO lacks the expertise or the device is not eligible for 3P510k 
539  review, the 3P510k RO should not accept the 510(k) submission for review from the 510(k) 
540  Submitter. If the 3P510k RO determines the device is ineligible for 3P510k review after they 
541  have already accepted the 510(k) submission, the 3P510k RO should immediately inform the 
542  510(k) Submitter and discontinue the review. 
 
49 The product code classification database is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm 
50 The list of eligible devices for third party review under the 3P510k Review Program is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
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543  3P510k ROs should establish policies designed to identify, prevent, and ensure reporting to FDA 
544  instances of forum shopping by 510(k) Submitters. 510(k) Submitters who consult with more 
545  than one 3P510k RO in order to find a review organization that is most likely to recommend 
546  clearance of a 510(k) submission undermine the independence and integrity of the 3P510k 
547  Review Program. 3P510k ROs should take steps to ensure that the submitters of the 510(k)s they 
548  are reviewing have not previously presented the submission to another RO and have not 
549  modified their device description or intended use to be reviewed by a different review office in 
550  FDA. 
551  If the 3P510k RO submits a 510(k) submission to FDA for an ineligible device, or a device the 
552  3P510k RO is not recognized to review (see Section V.D.(1) of this guidance), FDA will place 
553  the submission on hold and notify the 3P510k RO of FDAs eligibility assessment. Unless the 
554  3P510k RO intends to address the eligibility concerns, they should promptly consult with the 
555  510(k) Submitter and, if the 510(k) Submitter concurs, promptly send a 510(k) withdrawal 
556  request to FDA. If the 3P510k RO does not address eligibility concerns or withdraw the 
557  submission within 180 days, FDA will delete the file. A 510(k) Submitter cannot submit a 510(k) 
558  for the same device directly to FDA or to another 3P510k RO until the file is withdrawn 
559  voluntarily by the 3P510k RO or deleted automatically by FDA after 180 days. If a 3P510k RO 
560  has questions about the eligibility status of a device, they should contact the 3P510k mailbox at 
561  3P510K@fda.hhs.gov to seek clarification.   
562   
563  A 3PEUA RO should likewise review an EUA request to ensure that it is appropriate for 3PEUA 
564  review regardless of whether the EUA request is sent from FDA or directly from the EUA 
565  Submitter. This includes assessing whether the device is within the purview of the organizations 
566  contract with FDA (e.g., confirming the device type and intended use). If the EUA request is not 
567  appropriate for third party review, the 3PEUA RO should inform FDA.51 If the EUA request is 
568  for an in vitro diagnostic product that was sent by the EUA Submitter directly to the 3PEUA RO, 
569  the 3PEUA RO should inform FDA and the EUA Submitters designated correspondent. A 
570  3PEUA RO may communicate with FDA to confirm its assessment before informing the EUA 
571  Submitter. 
572  (2)  Assign a Product Specialist(s), Final Reviewer, and Technical 
573  Expert(s) to conduct the substantive review of a submission 
574   
575  Third Party Review Organization personnel should have appropriate education, training, skills, 
576  technical knowledge, qualifications, and experience to perform submission reviews for the 
577  device type(s) their organization is recognized and/or contracted to review. For additional 
578  discussion on FDAs recommendations regarding qualifications of personnel, see Section 
579  V.C.(2) of this guidance. 
580    
581  Each submission should be assigned to a Product Specialist with appropriate expertise for the 
582  type of device under review. The Product Specialist may add qualified Technical Experts to the 
583  review team to ensure sufficient competency in the review, if necessary. The Product Specialist 
 
51 FDA will provide a designated email address when issuing the final guidance.   
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584  should document the competencies of, and the rationale for, choosing to use any Technical 
585  Experts. Particular attention should be given to the expertise and impartiality of any external 
586  Technical Experts. For more information on using external Technical Experts, please see Section 
587  V.C.(3) of this guidance.   
588   
589  Third Party Review Organizations should also identify at least one Final Reviewer within its 
590  organization who is independent from prior review of the submission and is responsible for 
591  providing a final supervisory assessment of the Product Specialists work before it is submitted 
592  to FDA. This individual should have sufficient authority and competence to independently assess 
593  the quality and acceptability of the Product Specialists review of the submission. 
594  (3)  Obtain relevant FDA guidance(s) and information 
595   
596  Third Party Review Organizations should review and be familiar with publicly available 
597  information relevant to their review. For example:  
598    Third Party Review Organizations should review FDAs guidance database to obtain any 
599  relevant final guidance documents52 when conducting their reviews, including device-
600  specific and horizontal guidances (e.g., biocompatibility, software, sterility).  
601    3P510k ROs should be aware of any special controls, which are regulatory 
o
602  requirements for certain class II devices, that apply to that device type under 
603  review. For information on whether a device type has applicable special controls, 
604  3P510k ROs should review the regulation associated with the devices proposed 
605  classification under Title 21 of the Code of Federal Regulations (CFR),53 which 
606  will identify the mandatory special controls for a particular device type.   
607    For 3PEUA ROs conducting reviews specific to an applicable EUA declaration, 
o
608  FDAs Emergency Preparedness and Response website54 may provide additional 
609  information (e.g., EUA templates to assist EUA Submitters in preparing their 
610  requests).  
611    3P510k ROs should review FDAs postmarket databases, including recalls, market 
612  withdrawals, and safety reports;55 Medical Device Reports;56 and MedSun Reports57 for 
613  the predicate device and/or the device type to identify any issues with clinical use of 
614  similar devices that should be considered and addressed in the review of the subject 
615  device. If potential safety signals are identified by a 3P510k RO, they should contact 
616  FDA for information on current review practice (see Section V.B.(4) of this guidance).    
617   
 
52 The guidance database search engine allows users to search the inventory of guidances available by title, words, 
or origin and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents 
53 The Code of Federal Regulations Title 21 database is available at https://www.ecfr.gov/cgi-
bin/ECFR?page=browse  
54 Available at https://www.fda.gov/emergency-preparedness-and-response  
55 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 at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm 
56 The MAUDE database allows users to search for Medical Device Reports and is available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm 
57 The MedSun database allows users to search for adverse event reports from the Medical Product Safety Network 
and is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm  
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618    3P510k ROs should review publicly available premarket review information in FDAs 
619  510(k) database for information about the legally marketed device (predicate) to which 
620  a Submitter is comparing its device, or other similar devices,58 including Indications for 
621  Use Statements, 510(k) Summaries,59, 60 Decision Summaries, if available, and FDA 
622  decision letters. In some instances, a devices product code can also be used to identify a 
623  generic category of a device and assist with the identification of similar devices. Product 
624  codes can be found in FDAs product code database.61  
625   
626    If a submitter wishes to utilize standards, the Third Party Review Organization should 
627  review FDAs guidance document entitled Appropriate Use of Voluntary Consensus 
628  Standards in Premarket Submissions for Medical Devices.  
629   
630  Third Party Review Organizations should request that submitters fully inform them of any prior 
631  communications with FDA about a device under review, including but not limited to FDA 
632  feedback obtained through the Q-Submission program, Pre-EUAs, unsuccessful marketing 
633  applications, and other interactions. If applicable, 3P510k ROs should be familiar with the FDA 
634  Q-Submission Program, including the Pre-Submission process, through the guidance document 
635  entitled, Requests for Feedback and Meetings for Medical Device Submissions: The Q-
636  Submission Program.62 A 3P510k RO should request an authorization letter from the 510(k) 
637  Submitter granting FDA permission to share information about or from previous submissions 
638  with the 3P510k RO (e.g., Q-Submissions and 510(k)s) related to the device (see Section V.B.(9) 
639  of this guidance). If applicable, the Third Party Review Organization should coordinate with the 
640  submitter to obtain and review prior submission content for the device, any written feedback or 
641  meeting minutes resulting from prior interactions, and any additional data, studies and/or study 
642  protocols submitted in response to previous submissions prior to the current submission to FDA.  
643   
644  FDA will review only one submission for a device at a time. Therefore, 3P510k ROs should 
645  confirm that 510(k) Submitters submit only one submission for a specific device at a time. If a 
646  3PEUA RO receives an EUA request directly from a submitter, they should similarly check with 
647  FDA, through the 3PEUA mailbox that will be included in the final guidance, to ensure that a 
648  submission for the same device was not also submitted directly to FDA.  
649  (4)  Early Interaction with FDA 
650   
 
58 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 
59 See 21 CFR 807.92. 
60 See also the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)].  
61 The product code database is available on FDAs website at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm    
62Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
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651  Third Party Review Organizations should interact, as needed, with appropriate FDA staff prior to 
652  and during the review of submissions. For 3P510k review, EIs  those between the 3P510k RO 
653  and FDA prior to the substantive review  can be an important part of the 510(k) review process 
654  (for potential topics, refer to Section V.B.(4) of this guidance). These interactions help ensure 
655  timely and consistent 510(k) reviews by assisting in device eligibility determinations and 
656  identifying relevant issues and contemporary review criteria.  
657   
658  In their initial recognition applications, 3P510k ROs commit to EIs with FDA before reviewing a 
659  device type they have not previously reviewed (see Section V.D.(1) of this guidance). This 
660  interaction ensures that the 3P510k RO has the latest FDA thinking on relevant guidance, 
661  standards, and other considerations for that device type. FDA encourages EIs for all 3P510k 
662  submissions, particularly for the first review of any device type by an individual Product 
663  Specialist and for any subset of device type (i.e., device type by product code) they have not 
664  recently reviewed. Generally, FDA considers a recent review to be within the last six months.  
665   
666  Procedures on how to obtain EI are available on FDAs 510(k) Third Party Review Program 
667  website. The 3P510k Program Review Team intends to respond to 3P510k RO requests within 2 
668  business days of receipt of an EI request. The 3P510k Program Review Team intends to triage 
669  the EI request before sending to the appropriate review division. If that deadline cannot be met, 
670  FDA intends to work with the 3P510k RO to establish a reasonable timeline for a response. Each 
671  review division within FDA that receives an EI intends to respond within 7 calendar days. 
672   
673  Figure 5. 3P510k ROs Steps to Interacting Early with the FDA 
3P510k RO 
proceeds with 
510(k) review or 
3P510k RO  contacts the 
receives a  submitter to 
510(k)  determine next 
submission FDA Triages  steps
3P510k RO  3P510k RO  Question(s) 
Identifies  Contacts FDA with  received from  FDA Responds to 
Question(s) During  Question(s) 3P510k RO Review  3P510k RO
510(k) Review
Organization
674   
675   
676  To enable FDA to provide timely feedback to 3P510k ROs through this process, the EI should be 
677  succinct and focused on one or two key questions if possible. Focused key questions include 
678  asking FDA to clarify a particular issue for the 3P510k RO, such as whether the software in a 
679  device should be evaluated as a low risk or a high risk, or whether the product code in the 
680  submission (include the device description) is correct or if FDA would expect the device to be 
681  regulated under a different product code. The EI may ask whether FDA recommends additional 
682  testing for a device beyond what is reflected in the 510(k) summary of the predicate device. 
683  Please note that an EI should also include the 3P510k ROs proposed resolution of the issue. If 
684  an EI is overly broad or too detailed, FDA may be unable to provide feedback but will try to 
685  work with the 3P510k RO to focus on the key issue in the organizations review.   
686   
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687  FDA recommends EIs if there are questions about whether the submission is for a known device 
688  type with novel technology (e.g., addition of artificial intelligence/machine learning (AI/ML)) or 
689  whether the submission is appropriate for 3P510k review (e.g., possible data integrity issues).  
690   
691  For 3PEUA questions, rather than resorting to the EI process, 3PEUA ROs should check in 
692  regularly with FDA to remain up to date on any emerging understanding, templates, or 
693  expectations relevant to EUA review.   
694  (5)  Ensure a submission is administratively complete 
695   
696  To ensure that a submission is administratively complete, 3P510k ROs should conduct a review 
697  of the 510(k) submission based on 510(k) regulations from 21 CFR Subpart E to assess whether 
698  the 510(k) submission includes all the information necessary to conduct a substantive review and 
699  to reach a recommendation (i.e., SE or NSE) to submit to FDA.  
700   
701  The 510(k) submitter should utilize the electronic Submission Template and Resource (eSTAR) 
702  to facilitate the preparation of 510(k) submissions to make sure a submission is administratively 
703  complete. For more information on eSTAR, please see Section V.B.(9) of this guidance and the 
704  Electronic Submission Template for Medical Device 510(k) Submissions guidance.63 
705   
706  3PEUA ROs should likewise ensure that an EUA request has enough information to enable 
707  review before conducting a substantive review. The exact type and amount of data needed to 
708  support an EUA may vary depending on the nature of the declared emergency or threat of 
709  emergency and the nature of the candidate product.64 FDA anticipates that expectations of 
710  requests will be detailed at the time a contract is awarded for 3PEUA review as well as where or 
711  with whom to check for updates to that information. If the correspondent is not the manufacturer, 
712  but is acting on behalf of the manufacturer, the submission should include authorization for the 
713  correspondent to act on behalf of the manufacturer. This does not change who FDA considers to 
714  be the EUA Submitter. If FDA has posted on its website specific information recommended for 
715  the device type being reviewed (e.g., FDA posted a template for EUA requests for SARS-CoV-2 
716  antigen tests), it may be a helpful reference for this assessment. 
717   
718  Third Party Review Organizations should not act as a consultant for the submitter. It is the 
719  responsibility of the submitter to be familiar with the content and format requirements of a 
720  510(k) submission or EUA request prior to submitting to FDA or a Third Party Review 
721  Organization. If a submitter is not familiar with the 510(k) regulatory pathway, 3P510k ROs 
722  should direct them to resources such as FDAs guidance documents entitled, The 510(k) 
 
63 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-
template-medical-device-510k-submissions. As of October 1, 2023, 510(k) submissions are required to be submitted 
electronically using eSTAR unless meeting a criteria for waiver or exemption.   
64 See Emergency Use Authorization of Medical Products and Related Authorities, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-
products-and-related-authorities  
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723  Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],65 The 
724  Abbreviated 510(k) Program,66 and The Special 510(k) Program.67 If an EUA Submitter is 
725  not familiar with the process for obtaining authorization for emergency use of a device, the 
726  3PEUA RO should direct them to resources such as FDAs guidance document entitled, 
727  Emergency Use Authorization of Medical Products and Related Authorities68 or FDAs 
728  Emergency Use Authorization website.69 Third Party Review Organizations might also direct 
729  submitters to the Division of Industry and Consumer Education in the Office of Communication 
730  and Education.70  
731   
732  If the Third Party Review Organization determines that a submission is administratively 
733  complete, the organization should begin its substantive review of the submission. If the Third 
734  Party Review Organization identifies any deficiencies in the submission, they should contact the 
735  submitter to request the missing information.  
736  (6)  Conduct the substantive review of a submission 
737   
738  Substantive review will be different for 510(k) submissions and EUA requests.   
739   
740  Substantive review for 510(k)s focuses on the evaluation of SE as defined in section 513(i) of the 
741  FD&C Act. 21 CFR 807.100(b) sets forth the criteria that FDA uses to determine whether a 
742  device is substantially equivalent to a legally marketed device. For information on making an SE 
743  determination under the 510(k) program, please see FDAs guidance document entitled The 
744  510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].  
745  For information on Abbreviated and Special 510(k)s, see FDAs guidance documents entitled 
746  The Abbreviated 510(k) Program and The Special 510(k) Program.  
747   
748  Review of an EUA request assesses the potential effectiveness of a possible EUA product on a 
749  case-by-case basis using a benefit-risk analysis.71 If, based on the totality of the scientific 
750  evidence available, it is reasonable to believe that the product may be effective for the specified 
751  use, FDA may authorize its emergency use, provided that other statutory criteria for issuing an 
752  EUA also are met. To enable FDA to reach a determination on whether to issue an EUA, the 
753  reviewer needs to document their assessment with particular attention to sections 564(c)(2)(A) 
754  and 564(c)(2)(B) of the FD&C Act. The 3PEUA RO review and recommendation should include 
 
65 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k  
66 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-
program 
67 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program 
68 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-
authorization-medical-products-and-related-authorities   
69 See FDAs Emergency Use Authorization website at https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization   
70 The contact information for the Division of Industry and Consumer Education is available at 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-
industry-and-consumer-education-dice 
71 See the guidance Emergency Use Authorization of Medical Products and Related Authorities.   
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755  those materials appropriate to the conditions of authorization discussed in Appendix A of the 
756  Emergency Use Authorization of Medical Products and Related Authorities guidance.72 The 
757  review and recommendation should also include a proposed indication for use. For example, an 
758  in vitro diagnostic product indication would typically include the sample type, the disease or 
759  condition being tested, when the test should be administered (e.g., within N days of symptoms or 
760  to anyone suspected of exposure), and by whom it can be used (e.g., a laboratory that meets the 
761  requirements to perform high or moderate complexity tests). FDA makes its own determinations 
762   and does not intend to seek recommendations from 3PEUA ROs  regarding whether other 
763  criteria for issuance are satisfied, including whether the agent that is the subject of the EUA 
764  declaration can cause a serious or life-threatening disease or condition under section 564(c)(1) of 
765  the FD&C Act and whether there is an adequate, approved, and available alternative to the 
766  product under section 564(c)(3) of the FD&C Act. 
767   
768  The Final Reviewer is responsible for providing a final supervisory assessment of the Product 
769  Specialists work before it is submitted to FDA. This individual should have sufficient authority 
770  and competence to independently assess the quality and acceptability of the Product Specialists 
771  review of the 510(k) submission.  
772  If Third Party Review Organizations identify any deficiencies during their substantive review, 
773  they should contact the submitter with a request that the deficiencies be addressed. Section 
774  V.B.(7) below provides further instruction on how to identify deficiencies in a submission. When 
775  the substantive review is complete, the Product Specialist(s), Technical Expert(s), if applicable, 
776  and Final Reviewer should reach an agreement on a final recommendation (e.g., SE or NSE to a 
777  predicate device for a 510(k) or authorization for an EUA73) before submitting the 
778  recommendation to FDA.   
779  (7)  Identify deficiencies in a submission 
780   
781  If a Third Party Review Organization identifies any deficiencies during their review, it should 
782  contact the submitter. Third Party Review Organizations may use any form of communication 
783  (e.g., telephone, email, or letter) to resolve the matter provided confidentiality is maintained and 
784  the interaction is documented. Third Party Review Organizations should, however, avoid the 
785  exchange of substantive data and information solely over the telephone to avoid errors that may 
786  arise in the absence of a written request and response.   
787  As part of providing an FDA-equivalent review, when requesting additional information from a 
788  510(k) Submitter, 3P510k ROs should structure their additional information requests as 
789  described in FDAs guidance document entitled Developing and Responding to Deficiencies in 
790  Accordance with Least Burdensome Provisions.74 This guidance document has examples of 
 
72 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-
authorization-medical-products-and-related-authorities#appA  
73 See sections 564(e)(1) or 564(e)(2) of the FD&C Act.  
74 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-
responding-deficiencies-accordance-least-burdensome-provisions 
26 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
791  well-constructed deficiencies and responses to FDAs requests. Note that while the guidance 
792  cited does not apply to EUAs, it is important that 3PEUA ROs also request additional 
793  information in a clear and structured format.   
794  Third Party Review Organizations should document the deficiencies, the submitters response to 
795  the deficiencies, and the discussion on the adequacy of the response in the Third Party Review 
796  Organizations review memorandum sent to FDA. With the review memorandum, a copy of all 
797  written communications related to resolving the deficiencies between the submitter and the Third 
798  Party Review Organization (e.g., email, letters, summary of teleconferences) should also be 
799  provided to the FDA. If the submitter made any modifications to the submission in response to a 
800  deficiency (e.g., revised 510(k) summary), the Third Party Review Organization should 
801  document this modification. Further, the Third Party Review Organization should request that 
802  the submitter provide the latest version of the submission prior to the Third Party Review 
803  Organization submitting to FDA. For example, if the Product Specialist requested an updated 
804  device description, the latest version should be included when the Third Party Review 
805  Organization sends the submission to FDA. However, the original device description text and the 
806  deficiency requesting an updated device description should be provided with the review memo. 
807  This will help ensure that FDA has the correct version of the submission on record. Proper 
808  documentation can also help address any appearance of the Third Party Review Organization 
809  having the role of a consultant.   
810  (8)  Document a review 
811   
812  Once a Third Party Review Organization has made a final recommendation, they should prepare 
813  their review documentation specifying the reasoning and steps that led to their final 
814  recommendation. 21 CFR 10.70 (Documentation of significant decisions in administrative file) 
815  provides a framework that should be utilized by Third Party Review Organizations. The content 
816  of the review documentation will vary based on the type of submission and device. 
817  Recommended review memorandum examples for documentation purposes are available on the 
818  FDA Third Party public website.75 The review memo should provide a clear narrative of: (1) 
819  how the device works; (2) for a 510(k), what information the submitter provided to demonstrate 
820  the device is SE to a legally marketed device, or, for an EUA request, based on the totality of the 
821  scientific evidence available, what information the submitter provided to demonstrate it is 
822  reasonable to believe that the product may be effective for the specified use; and (3) how the 
823  Third Party Review Organization evaluated that information.   
824   
825  If standards are referenced in a submission, FDA recommends Third Party Review Organizations 
826  discuss in their review memorandum how they were utilized in the submission. Submitters and 
827  Third Party Review Organizations should consult the FDA guidance entitled, Appropriate Use 
 
75 See FDAs third party website: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-
preparing-correct-submission/510k-third-party-review-program 
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  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
828  of Voluntary Consensus Standards in Premarket Submissions for Medical Devices76 for use of 
829  FDA-recognized consensus standards and use of other standards. 
830   
831  In addition to noting whether or not the necessary information required in a submission was 
832  included,77 the review memorandum should also convey how a Third Party Review Organization 
833  made their recommendation regarding the device. A thorough and substantive review 
834  memorandum should discuss the adequacy of each section of the submission. In general, FDA 
835  believes it will not be sufficient to state that a section of the submission or a response to a 
836  deficiency was adequate without providing an explanation of how the Third Party Review 
837  Organization came to that determination.  
838   
839  To facilitate FDAs review process, Third Party Review Organizations should reference sections 
840  and page numbers of the submission in their review memorandum where possible. Third Party 
841  Review Organizations should also clearly document in the review memorandum any 
842  deficiencies, the response to the deficiencies, and the Third Party Review Organizations review 
843  of the response as indicated in Section V.B.(7) of this guidance.  
844   
845  The review memorandum is the only means by which FDA can understand how and why a Third 
846  Party Review Organization recommended a device to be SE (or NSE) to the predicate device or 
847  receive an EUA. It is anticipated that thorough and clear documentation will reduce the need for 
848  FDA to re-review the submission itself and increase the efficiency of FDAs final review.78 
849  (9)  Organize and submit a submission including associated Third 
850  Party Review Organization review documentation   
851   
852  Upon completing the review of a submission, the Third Party Review Organization should 
853  submit the following to FDA: 
854     The submission generated by the submitter, and  
855    The review documentation generated by the Third Party Review Organization.  
856   
857  Submissions will need to follow the appropriate submission process.79  
858   
 
76 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices  
77 See 21 CFR 807 Subpart E. 
78 Through the MDUFA IV Commitment Letter, FDA commits to improving the Third Party Review Program with 
a goal of eliminating routine re-review by FDA of third party 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. Through the MDUFA V Commitment Letter, FDA commits to the 
continued improvement of the Third Party Review Program with a goal of eliminating routine re-review by FDA of 
third party reviews: See 168 CONG. REC. S5195-S5200 (daily ed. September 28, 2022) (Food and Drug 
Administration User Fee Reauthorization), also available at https://www.fda.gov/media/158308/download. See also 
Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews, available at 
https://www.fda.gov/media/116168/download  
79 For 510(k)s see FDAs website on the 510(k) submission process, available at https://www.fda.gov/medical-
devices/premarket-notification-510k/510k-submission-process 
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859  The 510(k) Submitters document and the 3P510k ROs documents must be in electronic format 
860  per section 745A(b)(2) of the FD&C Act unless it meets the criteria for exemptions and 
861  waivers.80 The electronic submission template, eSTAR, is the only currently available electronic 
862  submission template to facilitate the preparation of 510(k) electronic submissions. The 510(k) 
863  Submitter should take care to submit the latest version of the 510(k) submission to the 3P510k 
864  RO. This version should include any documents that have been updated in response to 
865  deficiencies from the 3P510k RO. The 3P510k RO will submit all documents to FDA via the 
866  directions outlined on the CDRH Portal.81 
867   
868  For 3PEUA submissions, unless otherwise requested by FDA, the 3PEUA RO should submit 
869  files to the CDRH Portal or CDRHs Document Control Center.82 In the event that the EUA 
870  Submitter has amended their original submission during the 3PEUA review, or the submission 
871  was sent directly to the 3PEUA RO, the 3PEUA RO should submit two separate sets of files, one 
872  set for the updated EUA request and one for the 3PEUA ROs review of the EUA request. In the 
873  case where the original EUA request was sent to FDA and it does not need amending, the 
874  3PEUA Final Reviewer need only submit their review files. Please refer to FDAs guidance 
875  entitled eCopy Program for Medical Device Submissions83 for more information on how to 
876  submit through the eCopy program.  
877   
878  To facilitate FDAs review, we recommend that a Third Party Review Organizations 
879  documentation include the following: 
880   
881  For both 3P510k ROs and 3PEUA ROs:  
882   
883    A cover letter signed by the Final Reviewer that clearly identifies:  
884    The purpose of the submission, e.g., a new 3P510k review and submission, a new 
o
885  3PEUA review and submission, a Third Party Review Organizations review to an 
886  existing 510(k) or EUA submission number provided by FDAin this case clearly 
887  indicate the 510(k) or EUA submission number; 
888    The name and address of the Third Party Review Organization and the contact 
o
889  person; 
890    The name, email, and telephone number of the Final Reviewer; 
o
891    The name and address of the submitter; 
o
 
80 As noted in the guidance Electronic Submission Template for Medical Device 510(k) Submissions, all 510(k) 
submissions including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent 
Supplements and Amendments and any other subsequent submissions to an original submission, unless exempted 
in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the guidance, are required 
to be submitted as electronic submissions.  
81
The CDRH Portal is available at https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-
medical-device-premarket-submissions-online-cdrh-portal 
82 CDRHs Document Control Center is available at https://www.fda.gov/medical-devices/how-study-and-market-
your-device/ecopy-program-medical-device-submissions  
83 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-
medical-device-submissions  
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892    The name of the device (trade name, common or usual name, FDA classification 
o
893  regulation name, classification regulation number, and product code, as 
894  applicable); 
895    The Third Party Review Organizations recommendation (SE or NSE, 
o
896  authorization) with respect to the device; and  
897    For submissions sent directly to Third Party Review Organizations by submitters, 
o
898  the date when the submission was judged administratively complete and ready for 
899  substantive review.  
900    A signed certification that the reported information accurately reflects the data reviewed 
901  and that no material fact has been omitted. This certification should also state that the 
902  Third Party Review Organization continues to meet personnel qualifications and 
903  prevention of conflicts of interest criteria reviewed by FDA; that the Third Party Review 
904  Organizations review is based on the submission that is being submitted with the review; 
905  and that the Third Party Review Organization understands that the submission of false 
906  information to the government is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q).  
907    The submitters complete submission. The submission should be prepared by the 
908  submitter, not the Third Party Review Organization. This information should be separate 
909  from the Third Party Review Organizations documentation and should be the latest 
910  version (see Section V.B.(7) of this guidance for more information). Proper 
911  documentation can help address any appearance of the Third Party Review Organization 
912  having the role of a consultant.   
913    For 510k submissions: The submission should conform to FDA's requirements for 
o
914  content and format as provided in 21 CFR part 807 subpart E and utilize eSTAR. 
915    A review memorandum including complete documentation of the Third Party Review 
916  Organizations review of the submission as described in Sections V.B.(7) and V.B.(8) of 
917  this guidance, signed by all personnel who conducted the review (generally the Product 
918  Specialist(s), Technical Expert(s), when applicable, and Final Reviewer), with a decision 
919  recommendation.  
920   
921  For 3P510k ROs: 
922    A review of the 510(k) submission contents that show the submission was 
923  administratively complete and includes all of the information necessary for the 3P510k 
924  RO to conduct a substantive review on FDAs behalf. A summary of any EI consults that 
925  occurred prior to the 510(k) submission to FDA with FDA staff, if appropriate (see 
926  Section V.B.(4) of this guidance).  
927   
928  For 3PEUA ROs: 
929    A review of the EUA request contents to show that the EUA request includes all of the 
930  information necessary for the 3PEUA RO to conduct a substantive review on FDAs 
931  behalf. If a template exists for the device type, it may be a helpful reference for this 
932  assessment.  
933   
934  For submissions submitted directly to Third Party Review Organizations: 
935    For 510(k)s : A letter signed by the 510(k) Submitter authorizing the 3P510k RO to 
936  submit the 510(k) to FDA on their behalf and authorizing the 3P510k RO to discuss the 
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Draft  Not for Implementation 
 
937  contents of the 510(k) with FDA on their behalf. This letter should also authorize FDA to 
938  discuss other, related submission(s) from the same 510(k) Submitter with the 3P510k RO 
939  and should include a list of those submission numbers.   
940   
941  FDA will begin its review of the Third Party Review Organizations recommendation only after 
942  we receive all documentation we believe is needed to conduct its review.  
943  (10) Submit additional information upon FDAs request 
944   
945  After a Third Party Review Organization has submitted their recommendation to FDA, including 
946  the associated Third Party Review Organization review documentation, FDA will begin to 
947  review the Third Party Review Organization review documentation, and if necessary, the  
948  submission. If FDA determines that additional information is needed to make a final decision 
949  (i.e., an SE determination or authorization), we will contact the Third Party Review Organization 
950  either by telephone or email.84 Such requests will describe FDAs concerns with a submission, 
951  and identify the information needed to address those concerns.  
952   
953  If FDA places a submission on hold (i.e., officially suspends review of the submission pending 
954  FDAs receipt of additional information), we will send an email informing the Third Party 
955  Review Organization of the on hold status and request additional information. For more 
956  information on a request for additional information for a 510(k) submission, please see FDAs 
957  guidance entitled FDA and Industry Actions on Premarket Notification (510(k)) Submissions: 
958  Effect on FDA Review Clock and Goals.85  
959  Upon receiving a request from FDA for additional information, the Third Party Review 
960  Organization should: 
961    Promptly inform the submitter of FDAs request for additional information relating to 
962  the submission and request that the submitter provide responses to the Third Party 
963  Review Organization in writing. The Third Party Review Organization should be 
964  involved in any discussions with FDA regarding the request for additional 
965  information, such as if the submitter seeks clarification from FDA or a 510(k) 
966  Submitter requests a Submission Issue Meeting86 with FDA; 
967    Thoroughly review any additional information provided by the submitter to ensure 
968  that it adequately responds to FDAs concerns; 
969    Document their review of the response to the deficiency by providing a clear and 
970  thorough assessment of whether and how the response adequately addresses FDAs 
971  deficiency  this should include updating the review documentation accordingly; 
 
84 Through the MDUFA V Commitment Letter, FDA will continue to support the Third Party Review program, with 
the objective of eliminating routine re-review by FDA of Third Party reviews: See 168 CONG. REC. S5195-S5200 
(daily ed. September 28, 2022) (Food and Drug Administration User Fee Reauthorization), also available at 
https://www.fda.gov/media/158308/download 
85 Available 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  
86 See the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program.  
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972    Prepare a cover letter referencing the submission number previously assigned by 
973  FDA (i.e., 510(k) number or EUA number) and identifying the purpose of the new 
974  submission (i.e., response to deficiencies); and  
975   
976    For 510(k)s, send an updated eSTAR via the CDRH Portal, and for EUAs, send any 
977  update to the CDRH Portal, the CDRHs Document Control Center or as otherwise 
978  indicated by FDA.   
979  The Third Party Review Organization should provide to FDA the two separate sets of 
980  documents87 (the new submission document(s) generated by the submitter and the document 
981  generated by the Third Party Review Organization). Each set of documents should be clearly 
982  marked as belonging to the Third Party Review Organization or the submitter as appropriate. For 
983  information on formatting requirements, see Section V.B.(9) of this guidance. 
984   
985  FDA will resume its review after we receive the submitters response to the additional 
986  information request, documentation of the Third Party Review Organizations review, and the 
987  Third Party Review Organizations determination of the adequacy of the response to additional 
988  information requests. 
989  (11) Submission dispute resolution 
990   
991  Disputes may often be the result of misunderstanding or miscommunication, and FDA 
992  encourages Third Party Review Organizations to seek clarification, as needed, from FDA or the 
993  submitter during a review. In some cases, the misunderstanding may result from FDA making a 
994  determination based in part on information that is available to FDA but is not available to the 
995  Third Party Review Organization (e.g., other premarket submissions from the submitter). If the 
996  submitter disagrees with an FDA decision or action, the Third Party Review Organization should 
997  maintain impartiality and exercise care to avoid the appearance of conflict of interest that may 
998  result from acting or appearing to act as an advocate on the submitters behalf.    
999   
1000  For 510(k) submissions, FDA has developed guidance documents that provide an overview of 
1001  the appeals processes available for medical devices, see Center for Devices and Radiological 
1002  Health Appeals Processes88 and Center for Devices and Radiological Health Appeals 
1003  Processes: Questions and Answers About 517A.89 The processes for reviewing and 
1004  reconsidering FDA decisions or actions on other 510(k) submissions are also available for 
1005  3P510k submissions when a dispute between FDA and a 510(k) Submitter arises. 
1006   
1007  If a 510(k) Submitter would like to issue a complaint against a 3P510k RO, communication 
1008  should be sent to 3P510K@fda.hhs.gov.       
 
87 See the guidance eCopy Program for Medical Device Submissions. 
88 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-
radiological-health-cdrh-appeals-processes 
89 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-
radiological-health-cdrh-appeals-processes-questions-and-answers-about-517a 
32 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1009    FDA Expectations of Third Party Review Organizations 
1010  and for Recognition and Rerecognition of 3P510k Review 
1011  Organizations  
1012   
1013  FDA considers criteria when deciding to recognize 3P510k ROs to conduct premarket reviews of 
1014  eligible 510(k)s.  
1015   
1016  In accordance with section 523(b)(3) of the FD&C Act, a 3P510k RO shall, at a minimum, meet 
1017  the following qualification requirements. Such person: 
1018    May not be an employee of the Federal Government; 
1019    Shall be an independent organization, which is not owned or controlled by a 
1020  manufacturer, supplier, or vendor of devices, and which has no organizational, material, 
1021  or financial affiliation with such a manufacturer, supplier, or vendor; 
1022    Shall be a legally constituted entity permitted to conduct the activities for which it seeks 
1023  recognition; 
1024    Shall not engage in the design, manufacture, promotion, or sale of devices; 
1025    The operations of such person shall be in accordance with generally accepted 
1026  professional and ethical business practices; and  
1027    Shall agree, at a minimum, to include in its request for accreditation a commitment to, at 
1028  the time of accreditation, and at any time it is performing any review pursuant to section 
1029  523:  
1030    Certify that reported information accurately reflects data reviewed; 
o
1031    Limit work to that for which competence and capacity are available; 
o
1032    Treat information received, records, reports, and recommendations as proprietary 
o
1033  information; 
1034    Promptly respond and attempt to resolve complaints regarding its activities for 
o
1035  which it is recognized; and  
1036    Protect against the use, in carrying out the review of a 510(k) submission and 
o
1037  initial classification of a device, of any officer or employee of the person who has 
1038  a financial conflict of interest regarding the device, and annually make available 
1039  to the public disclosures of the extent to which the 3P510k RO, and the officers 
1040  and employees of the 3P510k RO, have maintained compliance with requirements 
1041  relating to financial conflicts of interest. 
1042   
1043  Congress directed FDA to issue guidance on consultations with third party reviewers of EUAs 
1044  under section 565(i) of the FD&C Act, including considerations concerning conflicts of 
1045  interest.90 Consistent with this directive and existing policy with respect to 3PEUA review of 
1046  medical devices, including in vitro diagnostic products, FDA will take into consideration the 
1047  potential for financial conflicts of interest regarding the device. 
1048   
1049  In addition to these minimum requirements set forth in section 523(b)(3) of the FD&C Act, a 
1050  Third Party Review Organization should also consider any additional qualifications applicable to 
 
90 See section 2502(b) of the FY 2023 Omnibus. 
33 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1051  its type of review that are announced in the Federal Register. For 3P510k ROs, these 
1052  qualifications include establishing policies designed to identify, prevent, and ensure reporting to 
1053  FDA of instances where 510(k) Submitters submit substantially the same submission to multiple 
1054  3P510k ROs in order to find the one most likely to recommend a SE determination of the 510(k) 
1055  submission. Such forum shopping would undermine the independence and integrity of the 
1056  3P510k Review Program.91  
1057  (1)  Operational considerations 
1058   
1059  All submissions and communications with FDA and all documentation pertaining to the review 
1060  of a 510(k) or EUA submission submitted to FDA should be in English.  
1061   
1062  (2)  Management of impartiality 
1063   
1064  FDA expects Third Party Review Organizations to be impartial and free from any commercial, 
1065  financial, and other pressures that might present a conflict of interest or an appearance of a 
1066  conflict of interest. Therefore, FDA will consider whether the potential Third Party Review 
1067  Organization has established, documented, and executed policies and procedures to prevent any 
1068  individual or organizational conflict of interest or the appearance of a conflict of interest, 
1069  including conflicts of interests pertaining to their external Technical Experts. Policies and 
1070  procedures intended to address this issue should be consistent with IMDRF GRRP WG N59 
1071  Final:2020 Requirements for Regulatory Authority Recognition of Conformity Assessment 
1072  Bodies Conducting Medical Device Regulatory Reviews92 and IMDRF GRRP WG/N40 
1073  FINAL:2017  Competence, Training, and Conduct Requirements for Regulatory Reviewers.93 
1074  For more information on IMDRF GRRP and MDSAP, see Section V.F of this guidance below. 
1075   
1076  FDA recommends that Third Party Review Organizations also address the following to prevent a 
1077  potential conflict of interest: 
1078   
1079    Third Party Review Organizations should not participate in the preparation of 
1080  submissions. For more information, see Section V.B.(5) of the guidance. 
1081    Third Party Review Organizations should not task an individual, whether employee or 
1082  contractor, with reviewing a submission, if that individual was employed within the 
1083  last twelve months by that submitter or by a firm who helped prepare that submission. 
 
91 As noted in Medical Devices; Implementation of Third Party Review Under the Food and Drug Administration 
Modernization Act of 1997; Emergency Processing Request Under OMB Review, 63 FR 28390, May 22, 1998, 
available at https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf  
92 IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of Conformity 
Assessment Bodies Conducting Medical Device Regulatory Reviews can be found at 
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf 
93IMDRF 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 
34 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1084  Personnel should not review a medical device that they developed, helped develop, or 
1085  prepared for submission.  
1086    Third Party Review Organizations should not promise or advertise any guarantees for 
1087  FDA clearance or authorization. 
1088   
1089  Information on the conflict of interest standards FDA applies to its own review personnel is 
1090  included in the document entitled Standards of Ethical Conduct for Employees of the Executive 
1091  Branch.94 Third Party Review Organizations are encouraged to refer to these standards in 
1092  safeguarding their operations against conflicts of interest. 
1093   
1094  The conflict of interest policies for a Third Party Review Organization should be fully 
1095  implemented and there should be an attestation that those policies have been implemented that is 
1096  signed by the most responsible individual at the organization before any submission is accepted 
1097  for review. When using external Technical Experts, see Section V.C.(4) of this guidance for 
1098  more information on conflicts of interest safeguards.  
1099  (3)  Personnel involved in reviewing activities 
1100   
1101  Third Party Review Organizations and their personnel95 should demonstrate knowledge and 
1102  experience with the following, as applicable: 
1103   
1104    The Federal Food, Drug, and Cosmetic Act;  
1105    The Public Health Service Act; and 
1106    Regulations in the Code of Federal Regulations implementing these statutes, 
1107  particularly 21 CFR Chapter I Subchapter H.  
1108   
1109  Additionally, the Third Party Review Organization should: 
1110   
1111    Establish, document, and execute policies and procedures to ensure that submissions 
1112  are reviewed by qualified personnel. 
1113    Maintain records on the relevant education, training, skills, and experience of all 
1114  personnel who contribute to the technical review of a submission. 
1115    Make available to its personnel clear written instructions for duties and 
1116  responsibilities with respect to reviews conducted for FDA. 
1117    Employ personnel who are qualified in all the scientific disciplines relevant to the 
1118  submission that the 3P510k RO accepts for review or that the 3PEUA RO is under 
1119  contract to review.  
 
94 Available at: 
https://www.oge.gov/web/OGE.nsf/0/A8ECD9020E3E384C8525873C0046575D/$FILE/SOC%20as%20of%2085
%20FR%2036715%20FINAL.pdf   
95 For additional information on the criteria for 3P510k RO personnel qualifications see Medical Devices; 
Implementation of Third Party Review Under the Food and Drug Administration Modernization Act of 1997; 
Emergency Processing Request Under OMB Review, 63 FR 28388, May 22, 1998, available at 
https://www.gpo.gov/fdsys/pkg/FR-1998-05-22/pdf/98-13799.pdf 
35 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1120    Identify at least one individual who is responsible for providing supervision over 
1121  reviews and who has sufficient authority and competence to assess the quality and 
1122  acceptability of these reviews. 
1123   
1124  In addressing the items enumerated above in this section, Third Party Review Organizations 
1125  should be consistent with IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory 
1126  Authority Recognition of Conformity Assessment Bodies Conducting Medical Device 
1127  Regulatory Reviews,96 including, but not limited to, maintaining a quality management system, 
1128  and IMDRF GRRP WG/N40 FINAL:2017: Competence, Training, and Conduct 
1129  Requirements for Regulatory Reviewers.97 For more information on IMDRF GRRP, see 
1130  Section V.F of this guidance below. 
1131   
1132  In addition, Third Party Review Organizations will be expected to consult national and/or 
1133  international standards recognized by FDA as well as FDA guidance documents. Third Party 
1134  Review Organizations should have the capability to interface with FDAs electronic data systems 
1135  and websites through which the Third Party Review Organization can search for relevant 
1136  guidance documents, recognized standards, predicate summaries where appropriate, and publicly 
1137  available information regarding adverse events and recalls when performing review of similar 
1138  devices. FDA may also provide additional guidances and templates in certain emergency 
1139  situations, including as an emergency evolves (e.g., FDA published templates on its website for 
1140  SARS-COV-2 tests).   
1141   
1142  3P510k ROs must certify in their application that designated personnel will attend FDAs 
1143  training for recognition and rerecognition (see Section V.D.(1) of this guidance and the Federal 
1144  Register notice published on May 22, 1998 (63 FR 28388)). 3P510k ROs are expected to 
1145  complete training before conducting any 510(k) reviews under the program. FDA will not accept 
1146  reviews and recommendations of 510(k) submissions from 3P510k ROs that have failed to have 
1147  at least one designated person attend an FDA training session for recognition.   
1148   
1149  3PEUA ROs personnel are also expected to be appropriately trained. 3PEUA ROs should 
1150  reference the resources available through CDRH Learn98 to ensure personnel are familiar with 
1151  the basics of FDAs regulation of medical devices and CDRHs structure prior to reviewing an 
1152  EUA request. Personnel reviewing in vitro diagnostic products should complete the in vitro 
1153  diagnostic product training prior to reviewing an EUA request for such product. 3PEUA ROs 
1154  should also be familiar with FDAs guidance Emergency Use Authorization of Medical 
1155  Products and Related Authorities. When reviewing an EUA request that references standards, 
1156  personnel should complete the relevant CDRH training on the use of standards and the 
1157  Accreditation Scheme for Conformity Assessment (ASCA). Depending on the circumstances of 
 
96 IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of Conformity 
Assessment Bodies Conducting Medical Device Regulatory Reviews can be found at 
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf  
97 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 
98 CDRH Learn is available at https://www.fda.gov/training-and-continuing-education/cdrh-learn.  
36 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1158  an emergency, FDA may also recommend other device-specific trainings prior to 3PEUA ROs 
1159  reviewing EUA requests.     
1160   
1161  3P510k ROs should be prepared to conduct technically competent 510(k) reviews before 
1162  requesting recognition by FDA. FDA recommends persons reviewing 510(k) submissions review 
1163  at a 3P510k RO meet the appropriate qualifications (e.g., specialized education and experience) 
1164  provided in this guidance. When a 3P510k RO requests to expand the scope of device types for 
1165  which they may review 510(k) submissions, it should ensure through its policies and procedures 
1166  in place that its staff are qualified in the scientific disciplines for the new device types.  
1167  (4)  Use of external Technical Experts 
1168   
1169  The following are FDAs recommendations when Third Party Review Organizations use an 
1170  external Technical Expert: 
1171   
1172    The Third Party Review Organization should ensure that external Technical Experts 
1173  meet the same standards as those who work within the Third Party Review 
1174  Organization, such as freedom from conflicts of interest;  
1175    The Third Party Review Organization should ensure that external Technical Experts 
1176  are discouraged from subcontracting parts of their contract to subcontractors, and if 
1177  they do so, then the external Technical Expert should ensure that the subcontractor 
1178  meets all requirements applicable to the external Technical Expert; and  
1179    Third Party Review Organizations should maintain records of the qualifications of 
1180  external Technical Experts, in addition to evidence of regular monitoring of the 
1181  established competence, conflicts of interest and the degree of fulfillment of the 
1182  outsourced work. 
1183   
1184  For 3P510k ROs, since they request a list of product codes to be recognized to review, they 
1185  should ensure they have sufficient competence among their own staff to review the device types 
1186  covered by those product codes. There should be at least one qualified Product Specialist per 
1187  device type that the 3P510k RO is recognized to review. This is to ensure that there is not 
1188  excessive reliance on external expertise by a 3P510k RO and to enable appropriate oversight of 
1189  the qualifications of external Technical Experts by 3P510k ROs. For 3PEUA ROs, FDA may 
1190  request information in the form of curricula vitae (CVs) or resumes to ensure sufficient expertise 
1191  and identify key personnel in contracts.  
1192   
1193  In addressing the items above, Third Party Review Organizations should be consistent with 
1194  IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of 
1195  Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews99 and  
1196  IMDRF GRRP WG/N40 FINAL:2017: Competence, Training, and Conduct 
 
99 IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of Conformity 
Assessment Bodies Conducting Medical Device Regulatory Reviews can be found at 
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf  
37 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1197  Requirements for Regulatory Reviewers.100 For more information on IMDRF GRRP and 
1198  MDSAP, see Section V.F of this guidance below. 
1199  (5)  Confidential information 
1200   
1201  A Third Party Review Organization is required to treat information received in submissions, as 
1202  well as certain information contained in records, reports, and recommendations as proprietary 
1203  information (for 3P510k review, see section 523(b)(3)(F)(iii) of the FD&C Act) and may not 
1204  generally publicly disclose confidential commercial information or any trade secret (for 3P510k 
1205  review, see also section 301(y)(2) of the FD&C Act).101 Also, in accordance with 21 CFR 
1206  807.95, when a 510(k) is submitted by a device manufacturer to FDA, FDA will not publicly 
1207  disclose that submission if certain conditions are met. Similarly, FDA will generally not publicly 
1208  disclose that an EUA request has been submitted prior to issuing an EUA authorization. Thus, a 
1209  Third Party Review Organization should not publicly disclose a submission for a device that is 
1210  not currently on the market and where the intent to market the device has not been disclosed.   
1211   
1212  FDA will determine whether information submitted to FDA by a Third Party Review 
1213  Organization can be released in accordance with the Trade Secrets Act, Freedom of Information 
1214  Act, 21 CFR part 20 and 21 CFR 807.95, regarding confidentiality of information in 510(k)s. In 
1215  general, submissions submitted by Third Party Review Organizations and associated review 
1216  documentation will be available for disclosure by FDA after the agency has issued an SE or 
1217  authorization decision for a device, unless the information is exempt or prohibited from public 
1218  disclosure under 21 CFR part 20 or 21 CFR 807.95, among other relevant authorities. FDA may 
1219  seek predisclosure notification input from 510(k) and EUA submitters consistent with 21 CFR 
1220  20.61, as appropriate.  
1221   
1222  In addition, information submitted by a 3P510k RO to obtain recognition or rerecognition from 
1223  FDA is available for public disclosure unless exempt or prohibited from public disclosure. 
1224  (6)  Complaints regarding Submitters 
1225   
1226  The 3P510k RO should send to FDA via email to 3P510K@fda.hhs.gov information on any 
1227  complaint (e.g., whistleblowing) it receives about a 510(k) Submitter that could indicate an issue 
1228  related to the safety or effectiveness of a medical device or a public health risk. 
1229   
1230  A 3PEUA RO should send such a complaint about an EUA submitter via email to the contact 
1231  provided in its contract with FDA.  
1232  (7)  Third Party Review Organization recordkeeping  
1233   
 
100 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 
101 For contracts, see section 708(a) of the FD&C Act and 21 CFR 20.90. 
38 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1234  Pursuant to section 704(f) of the FD&C Act, a 3P510k RO must maintain records that support its 
1235  initial and continuing qualifications to receive FDA recognition. These records must include the 
1236  following: 
1237   
1238    Documentation of the training and qualifications of the Third Party Review 
1239  Organization and its personnel; 
1240    The procedures used by the Third Party Review Organization for handling 
1241  confidential information;  
1242    The compensation arrangements made by the 3P510k RO; and 
1243    The procedures used by the Third Party Review Organization to identify and avoid 
1244  conflicts of interest. 
1245   
1246  3PEUA ROs would maintain records as described in the contract between FDA and the 3PEUA 
1247  RO, as applicable. 
1248   
1249  In addition, FDA recommends that Third Party Review Organizations retain the following 
1250  records for at least three years (3) following the submission of a submission for review to FDA:   
1251   
1252    Copies of all submission reviews and associated correspondence; 
1253    Information on the identity and qualifications of all personnel who contributed to the 
1254  technical review of each submission; and  
1255    Other relevant records. 
1256   
1257  In addressing the items enumerated above, Third Party Review Organizations should be 
1258  consistent with IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority 
1259  Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory 
1260  Reviews102, including records consistent with their quality management system, and IMDRF 
1261  GRRP WG/N40 FINAL:2017: Competence, Training, and Conduct 
1262  Requirements for Regulatory Reviewers.103 For more information on the IMDRF documents, 
1263  see Section V.F of this guidance. 
1264    
1265  In accordance with section 704(f)(1) of the FD&C Act, 3P510k ROs must make the records 
1266  specified in that section available upon request by FDA. 3P510k ROs shall permit an FDA 
1267  officer or employee at all reasonable times to have access to, copy, and/or verify these records. 
1268  Within 15 days of receipt of a written request from FDA, 3P510k ROs must make copies of the 
1269  requested records available at the place FDA designates.104 If FDAs monitoring of the 3P510k 
1270  Review Program, such as a review of compensation arrangements between 3P510k ROs and 
1271  510(k) Submitters, reveals that 510(k) Submitters are developing business relationships with 
 
102 IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of Conformity 
Assessment Bodies Conducting Medical Device Regulatory Reviews can be found at 
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf 
103 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 
104 See section 704(f)(2) of the FD&C Act. 
39 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1272  3P510k ROs that call into question the independence or objectivity of a 3P510k RO, FDA will 
1273  consider limiting a Submitters choice of 3P510k ROs. Business relationships that may 
1274  undermine the independence or objectivity of a 3P510k RO include, for example, contracts 
1275  between a manufacturer and a 3P510k RO that represent a significant share of the 3P510k ROs 
1276  income.   
1277   
1278  3PEUA ROs would make records available as described in the contract between FDA and the 
1279  3PEUA RO, as applicable.  
1280   
1281  Section 523(b)(3)(F)(iv) of the FD&C Act requires 3P510k ROs to agree that they will promptly 
1282  respond and attempt to resolve complaints regarding the activities for which they are accredited. 
1283  FDA recommends that 3P510k ROs establish a recordkeeping system for tracking the 
1284  submission of those complaints and how those complaints were resolved, or attempted to be 
1285  resolved. FDA recommends that 3PEUA ROs maintain similar records. 
1286    Content and Format of an Application for Initial 
1287  Recognition and Rerecognition as a 3P510k Review 
1288  Organization 
1289   
1290  This section of the guidance provides FDAs recommendations on what should be included in an 
1291  application to FDA for recognition as a 3P510k RO.105 The 3P510k RO should inform FDA 
1292  promptly if they would like to suspend, withdraw, cancel or reduce the scope of their program. 
1293  FDA will adjust recognition or rerecognition as appropriate.  
1294  (1)  Initial Recognition  
1295   
1296  Organizations that wish to become recognized as 3P510k ROs under section 523 of the FD&C 
1297  Act should send their applications to FDA as a single portable document format (PDF) file to: 
1298   
1299  3P510k@fda.hhs.gov 
1300  Attention: CDRH Third Party Premarket Review Program 
1301   
1302  Alternatively, applications can be sent by mail to the following address:  
1303   
1304  CDRH Third Party Premarket Review Program 
1305  U.S. Food and Drug Administration 
1306  Document Control Center (DCC)  WO66-G609 
1307  10903 New Hampshire Avenue, 
1308  Silver Spring, Maryland 20993 USA. 
1309  3P510K@fda.hhs.gov 
 
105 As discussed in Section II.B of this guidance, for 3PEUA ROs, FDA intends to contract with them directly based 
on the circumstances of an emergency, including when the Agency determines that help with review would be 
beneficial. 
40 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1310   
1311  To facilitate review of the application, FDA strongly encourages submission of an eCopy.106 
1312   
1313  FDA will acknowledge receipt with an email to the applicants designated contact person when 
1314  the application is received. FDA will review these materials and respond within 60 calendar 
1315  days107 of the date of the receipt of the application with a decision to recognize or deny 
1316  recognition, or a request for additional information. FDA may deem the application incomplete 
1317  and deny recognition if the applicant fails to respond to FDAs request for additional information 
1318  in a timely manner.   
1319   
1320  To facilitate review, the following information should be submitted in an application for FDAs 
1321  consideration: 
1322  a.  Administrative information 
1323    The name and mailing address of the 3P510k RO seeking recognition; 
1324    The telephone number, email address, and fax number of the contact person. The 
1325  contact person should be the person to whom questions about the content of the 
1326  application may be addressed and the person to whom a letter of determination and 
1327  general correspondence will be directed; 
1328    The name and title of the most responsible individual at the 3P510k RO;   
1329    A brief description of the 3P510k RO, including: type of organization (e.g., not-for-
1330  profit institution, commercial business, other type of organization); size of 
1331  organization (number of employees); number of years in operation; nature of work 
1332  (e.g., testing or certification laboratory); and information regarding ownership (i.e., 
1333  name of owner(s) and extent of ownership), operation, control of organization, and 
1334  other related information sufficient for FDA to assess its degree of independence 
1335  from entities such as device manufacturers and distributors;  
1336    A listing of any national, state, local, or other recognition; and 
1337    A list of the device types the applicant seeks to review by product codes or 
1338  classification regulation name and regulation. Please refer to the FDA Third Party 
1339  public website108 for devices that are eligible for 3P510k review. 
1340  b.  Prevention of conflicts of interest  
1341   
1342  A copy of the written policies and procedures established by the 3P510k RO to ensure that the 
1343  3P510k RO and its employees, external Technical Experts, contractors and individual contract 
1344  employees involved in the evaluation of 510(k)s are free from conflicts of interest, and to prevent 
 
106 For information on the eCopy program, please see FDAs guidance entitled eCopy Program for Medical Device 
Submissions.  
107 See section 523(b)(2)(A) of the FD&C Act. 
108 Information on third party eligible device types is available on FDAs website: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm 
41 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1345  any individual or organizational conflict of interest, or appearance of conflict of interest that 
1346  might affect the review process. 
1347  c.  Personnel qualifications 
1348   
1349  A list of personnel who will be involved in the preparation of the 3P510k ROs 510(k) 
1350  recommendations, including Product Specialists, Technical Experts, external Technical Experts, 
1351  and Final Reviewers. Applicants should demonstrate that these personnel are technically 
1352  competent to conduct 510(k) reviews and should document the following in their application: 
1353   
1354    The written policies and procedures established to ensure 510(k)s are reviewed by 
1355  qualified personnel; 
1356    The written instructions for the duties and responsibilities of personnel with respect to 
1357  510(k) reviews; 
1358    The written personnel standards established to ensure that designated personnel are 
1359  qualified in all of the scientific disciplines presented by the 510(k)s for devices for 
1360  which the 3P510k RO is applying for its review; 
1361    The documentation (e.g., CVs) to establish that the reviewers of 510(k)s (i.e., Product 
1362  Specialists and Technical Experts) and other involved non-supervisory personnel 
1363  meet the Recognition Criteria for qualified personnel. This includes documentation of 
1364  education, training, skills, abilities, and experience, including specialized education 
1365  and experience needed for the review of devices for which the 3P510k RO is applying 
1366  for its review; 
1367    The documentation (e.g., CVs) to establish that the supervisor(s) of 510(k) reviewers 
1368  (i.e., Final Reviewer) have sufficient authority and meet the Recognition Criteria for 
1369  qualified supervisory personnel. This includes documentation of education, training, 
1370  skills, abilities, and experience, including specialized education and experience 
1371  needed for the review of class II devices for which the 3P510k RO is applying for its 
1372  review; and  
1373    A description of the management structure, or, if an external technical expert is used 
1374  for 510(k) reviews, the external Technical Experts management structure. The 
1375  application should describe the position of the individual(s) providing supervision 
1376  within the management structure and explain how that structure provides for the 
1377  supervision of 510(k) reviewers and other personnel involved in the review process. 
1378   
1379  Throughout the period of recognition, a 3P510k RO should ensure its personnel remain 
1380  technically competent and only conduct 510(k) reviews for which they have the technical 
1381  competency to do the review. If a 3P510k RO does not continue to demonstrate its personnel 
1382  remain technically competent and only conduct 510(k) reviews for which they have technical 
1383  competency to do the review, FDA may take action at any time to ensure that the 3P510k RO is 
1384  only reviewing 510(k) submissions for which it has the technical competency to review. 
1385  d.  Certification statements 
1386   
42 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1387  As required by statute, and to support FDAs plan to eliminate routine re-review of 3P510(k) 
1388  submissions,109 the applicant must provide a statement in their application, signed by the most 
1389  responsible individual at the organization, certifying that the 3P510k RO has committed at the 
1390  time of accreditation and at any time it is performing any 3P510k review that it: 
1391   
1392    Will report information that accurately reflects data reviewed; 
1393    Will limit work and reviews to that for which competence and capacity are available, 
1394  including conducting 510(k) reviews in accordance with the policies and procedures 
1395  it has established regarding review of 510(k)s by qualified personnel; 
1396    Will treat any information, records, reports, and recommendations that it may 
1397  receives as proprietary and confidential information;  
1398    Will promptly respond and attempt to resolve complaints regarding the activities for 
1399  which it is recognized; 
1400    Will protect against conflicts of interests in accordance with policies and procedures 
1401  it has established relating to prevention of financial conflicts of interests, and 
1402  annually make available to the public disclosures of the extent to which the person, 
1403  and the officers and employees of the person, have maintained compliance with 
1404  requirements relating to financial conflicts of interest;  
1405   
1406  FDA also encourages the applicant to certify in its application that at all times, it:  
1407   
1408    Will demonstrate conformity while recognized by FDA with the requirements of 
1409  section 523 of the FD&C Act; 
1410    Will maintain records in a manner consistent with Section V.C.(7) of this guidance; 
1411    Will comply with the eCopy requirements for premarket submissions as described in 
1412  the guidance document entitled, eCopy Program for Medical Device Submissions; 
1413    Commits that its most responsible person or designee(s) will have completed FDA 
1414  training prior to performing any reviews by the 3P510k RO, and agrees that its most 
1415  responsible person or designee(s) will attend such training when offered and 
1416  applicable;  
1417    Will contact FDA for EI before reviewing any subset of device type (by respective 
1418  product code) that it has not reviewed as encouraged in Section V.B.(4) of this 
1419  guidance; and  
1420    Will commit to only accepting reviews where the 510(k) Submitters certified that any 
1421  relevant prior communications with FDA are disclosed. 
1422  (2)  Rerecognition 
1423   
1424  In accordance with section 523(b)(2)(D) of the FD&C Act, a 3P510k ROs recognition by FDA 
1425  will sunset 3 years from the date the recognition was granted. To continue conducting 3P510k 
1426  reviews beyond 3 years from the date of the last recognition or rerecognition, the 3P510k RO 
 
109 See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews, available at 
https://www.fda.gov/media/116168/download 
43 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1427  must obtain rerecognition. 3P510k ROs should apply for rerecognition a minimum of 60 
1428  calendar days before their recognition status expires to prevent any lapse in recognition. A 
1429  3P510k RO may request a rerecognition earlier if it so chooses. 
1430   
1431  Requests for rerecognition will be handled in the same manner as initial recognition requests. 
1432  Accordingly, rerecognition applications should follow the format described in Section V.C.(1) of 
1433  this guidance. For rerecognition, FDA may also consider the past premarket review performance 
1434  of the 3P510k RO and any information that comes to FDAs attention about the status of the 
1435  3P510k ROs recognition, including information from an audit.110 Through rerecognition, FDA 
1436  may also modify the product codes which personnel are reaccredited to review.111    
1437  (3)  Recognition or Rerecognition Denial 
1438   
1439  A 3P510k RO that wishes to request a reconsideration of a recognition denial or rerecognition 
1440  denial should appeal under 21 CFR 10.75 as a request for supervisory review following the 
1441  appeals process outlined in FDAs guidance entitled Center for Devices and Radiological 
1442  Health Appeals Processes.112 
1443    Suspension or Recognition Withdrawal 
1444   
1445  Section 523(b)(2)(B) of the FD&C Act authorizes FDA to suspend or withdraw recognition of 
1446  any 3P510k RO, after providing notice and an opportunity for an informal hearing, when the 
1447  3P510k RO is substantially not in compliance with the requirements of section 523 of the FD&C 
1448  Act, poses a threat to public health, or fails to act in a manner that is consistent with the purposes 
1449  of section 523.  
1450   
1451  Under section 301(y)(1) of the FD&C Act, the following actions are prohibited by a 3P510k RO: 
1452   
1453     Submission of a report or recommendation that is false or misleading in any material 
1454  respect; 
1455    Disclosure of confidential information or any trade secrets without the express written 
1456  consent of the person who submitted such information or secrets to the 3P510k RO; 
1457  and    
1458    Receipt of a bribe in any form or doing any corrupt act associated with a 
1459  responsibility delegated to the 3P510k RO under the FD&C Act.  
1460   
1461  In general, 3PEUA ROs should also refrain from the above activities substituting 3PEUA RO for 
1462  3P510(k) RO in the last two bullets and look to the contract between FDA and the 3PEUA RO 
1463  for specific requirements.   
1464   
 
110 See section 523(b)(2)(C) of the FD&C Act. 
111 See section 523(b)(2)(D)(iii) of the FD&C Act.  
112 See also the guidance Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and 
Answers About 517A. 
44 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1465  Furthermore, FDA intends to periodically evaluate completed premarket reviews of 510(k)s and 
1466  authorized EUAs submitted to FDA under the 3P510k Review Program or reviewed by a 3PEUA 
1467  RO and intends to provide feedback to Product Specialists and the Final Reviewer following 
1468  evaluation.   
1469   
1470  FDA intends to perform an assessment of each 3P510k RO on a periodic (at least once every 
1471  three years)113 or for cause basis as part of its auditing to ensure 3P510k ROs continue to meet 
1472  the standards of recognition (see section 523(b)(2)(C) of the FD&C Act). As resources allow, 
1473  assessments will involve inspecting a 3P510k ROs facility and/or records to ensure that the 
1474  3P510k RO is operating in accordance with the procedures, qualifications, and certifications 
1475  specified in the 3P510k ROs application and the FD&C Act.   
1476   
1477  3P510k ROs should continue to demonstrate technical competency to maintain recognition. If 
1478  monitoring of a 3P510k RO reveals nonconformity with section 523 of the FD&C Act, a threat 
1479  to the public health, or a failure to act in a manner that is consistent with the purposes of section 
1480  523, FDA may take steps to suspend or withdraw recognition of the 3P510k RO, after providing 
1481  notice and an opportunity for an informal hearing.114  
1482    Leveraging the International Medical Device Regulators 
1483  Forums (IMDRFs) documents  
1484   
1485  In February 2011, the IMDRF was convened to discuss future directions in medical device 
1486  regulatory harmonization. The IMDRF is a voluntary group of medical device regulators from 
1487  around the world, including representatives from the FDA, who collaborate to build on the strong 
1488  foundational work of the Global Harmonization Task Force on Medical Devices. The purpose of 
1489  the IMDRF is to accelerate international medical device regulatory convergence. 
1490   
1491  The IMDRF Good Regulatory Review Practices (GRRP) working groups developed documents 
1492  that provide the fundamental building blocks of third party review that can be applicable to 
1493  submissions such as 510(k) submissions and EUA requests by providing criteria for reviewer 
1494  competence, training, and conduct, and, for organizations, the expectations for entities 
1495  (Conformity Assessment Bodies or CABs) that perform regulatory reviews. Details are 
1496  outlined in a collection of documents finalized from 2017 through 2023 and available on the 
1497  IMDRF website.115   
1498   
 
113 See section 523(b)(2)(D)(i) of the FD&C Act. 
114 See section 523(b)(2)(B) of the FD&C Act. 
115 The IMDRF published eight documents related to GRRP. All the IMDRF documents are available on the IMDRF 
website at: https://www.imdrf.org/working-groups/good-regulatory-review-practices. This guidance references 
IMDRF GRRP WG N40 Final:2017, Competence, Training, and Conduct Requirements for Regulatory 
Reviewers, IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of 
Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, and IMDRF GRRP WG N66 
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical 
Device Regulatory Reviews.  
45 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
1499  There are many shared elements in FDAs statutory and regulatory criteria for Third Party 
1500  Review Organizations and IMDRF GRRP WG N40 FINAL:2017: Competence, Training, and 
1501  Conduct Requirements for Regulatory Reviewers, 116 IMDRF GRRP WG N59 Final:2020 
1502  Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies 
1503  Conducting Medical Device Regulatory Reviews. 117 These documents focus on expectations 
1504  for CABs and the individuals CABs engage to perform regulatory reviews and other related 
1505  functions under the respective medical device legislation, regulations, and procedures required in 
1506  its regulatory jurisdiction. 
1507   
1508  Due to these similarities, FDA believes that potential Third Party Review Organizations in 
1509  compliance with the GRRP documents cited, as appropriate, are likely to be in alignment with 
1510  most FDA 3P510k RO requirements and 3PEUA RO recommendations outlined in this guidance 
1511  document. Such organizations do not necessarily need to generate new documentation for FDA, 
1512  but rather can leverage existing documents in their applications to FDA and for ongoing 
1513  recordkeeping.  
 
116 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 
117 IMDRF GRRP WG N59 Final:2020 Requirements for Regulatory Authority Recognition of Conformity 
Assessment Bodies Conducting Medical Device Regulatory Reviews can be found at 
https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-rrar-cab-cmdrr-n59.pdf  
 
46