Contains Nonbinding Recommendations
Draft Not for Implementation
Best Practices for Selecting a Predicate 
Device to Support a Premarket 
Notification [510(k)] Submission
Draft Guidance for Industry and
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 
only.
Document issued on September 7, 2023.
You should submit comments and suggestions regarding this draft document within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the docket 
number listed in the notice of availability that publishes in the Federal Register.
For questions about this document regarding CDRH-regulated devices, contact the Office of 
Product Evaluation and Quality, Office of Regulatory Programs, Division of Regulatory 
Programs 1 (Submission Support) at 301-796-5640. For questions about this document regarding 
CBER-regulated devices, contact the Office of Communication, Outreach, and Development 
(OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Draft Not for Implementation
Preface
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00020006 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov, or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Contains Nonbinding Recommendations
Draft Not for Implementation
Table of Contents
I.  Introduction ............................................................................................................................. 1
II.  Background ............................................................................................................................. 2
A.  The 510(k) Process ........................................................................................................... 2
B.  510(k) Modernization ....................................................................................................... 3
III.  Scope ....................................................................................................................................... 4
IV.  How to use this guidance ........................................................................................................ 4
V.  Best practices for selecting a predicate device ....................................................................... 6
A.  Predicate devices cleared using well-established methods .............................................. 7
B.  Predicate devices meet or exceed expected safety and performance ............................... 8
C.  Predicate devices without unmitigated use-related or design-related safety issues ......... 9
D.  Predicate devices without an associated design-related recall ....................................... 10
VI.  Improving the Transparency of Predicate Devices ............................................................... 11
VII. Examples ............................................................................................................................... 12 Contains Nonbinding Recommendations
Draft Not for Implementation
Best Practices for Selecting a Predicate 
1 
Device to Support a Premarket 
2 
Notification [510(k)] Submission
3   
4 
 
Draft Guidance for Industry and 
5 
Food and Drug Administration Staff 
6 
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
10  and is not binding on FDA or the public.  You can use an alternative approach if it satisfies 
11  the requirements of the applicable statutes and regulations.  To discuss an alternative 
12  approach, contact the FDA staff or Office responsible for this guidance as listed on the title 
13  page.  
14   
I.  Introduction 
15 
16  FDA developed this document to provide guidance to industry and FDA staff about best 
17  practices in selecting a predicate device for premarket notification [510(k)] submissions. 
18  Specifically, this guidance recommends four (4) best practices to employ when selecting a 
19  predicate device used to support a 510(k) submission. The recommendations provided in this 
20  guidance are not intended to propose any changes to applicable statutory and regulatory 
21  standards, such as how FDA evaluates substantial equivalence, or the applicable requirements, 
22  including the requirement for valid scientific evidence. FDA developed this guidance to improve 
23  the predictability, consistency, and transparency of the 510(k) premarket review process. This 
24  guidance and associated recommendations are consistent with and are intended to be used in 
25 conjunction with the FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in 
26  Premarket Notifications [510(k)]1 (hereinafter, 510(k) Program Guidance) and other relevant 
27  FDA guidances on 510(k) submissions. 
28   
29  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
30  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
31 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
32 the word should in Agency guidances means that something is suggested or recommended, but 
33 not required. 
34
1Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k.
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II. Background 
35 
A. The 510(k) Process 
36
37  The framework under which FDA regulates medical devices was put into place when Congress 
38  enacted the Medical Device Amendments (Pub. L. 94-295) to the Federal Food, Drug, and 
39  Cosmetic Act (FD&C Act) on May 28, 1976. Under section 510(k) of the FD&C Act, a 
40  manufacturer must submit a premarket notification (often referred to as a 510(k)) to FDA at least 
41  90 days before introducing, or delivering for introduction, a device into interstate commerce for 
42  commercial distribution so the Agency can determine whether or not the device meets the criteria 
43  for market clearance (sections 510(k), 510(n), and 513(i) of the FD&C Act). A 510(k) is required 
44  for devices intended for human use, for which a premarket approval application (PMA) is not 
45  required, unless the device is exempt from the 510(k) requirements of the FD&C Act and does 
46  not exceed the relevant limitations of exemptions in the device classification regulations.  
47   
48  A 510(k) is a marketing submission made by a manufacturer to FDA to demonstrate that the 
49  device to be marketed is substantially equivalent to a predicate device (section 513(i) of the 
50  FD&C Act and 21 CFR 807.92(a)(3)-(6)). Substantial equivalence is rooted in a comparison 
51  between the new device2 and predicate device(s).3  
52   
53  The Agency bases its decision on whether the device is substantially equivalent (SE) to a 
54  predicate device using the statutory criteria in section 513(i) of the FD&C Act. For FDA to find a 
55  new device SE to a predicate device, FDA must first find that the new device and predicate 
56  device have the same intended use. FDA must then find that the new device and predicate device 
57  have the same technological characteristics, or if they do not, that the different technological 
58  characteristics4 of the new device do not raise different questions of safety and effectiveness and 
59  that the new device is as safe and effective as a predicate device. FDA conducts this evaluation 
60  by reviewing the proposed scientific methods for evaluating new/different technological 
61 characteristics effects on safety and effectiveness and accompanying performance data to 
62 determine whether the methods are acceptableand whether the data demonstratesSE. Anew 
63 device requiring premarket notificationcannot be introduced into interstate commerce for 
2For purposes of this guidance, a new device means a device within the meaning of section 201(h) of the FD&C 
Act that is not legally marketed. It can be either a completely new device (i.e., one that has not received FDAs 
marketing authorization) or a modification of a legally marketed device that would require a new 510(k).
3A predicate device is a legally marketed device. Under 21 CFR 807.92(a)(3), a legally marketed device to which a 
new device may be compared for a determination regarding substantial equivalence is a device that was legally 
marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I, or a device 
which has been found to be substantially equivalent through the 510(k) premarket notification process. Moreover, 
[a] device may not be found to be substantially equivalent to a predicate device that has been removed from the 
market at the initiative of [FDA] or that has been determined to be misbranded or adulterated by a judicial officer. 
Section 513(i)(2) of the FD&C Act.
4For purposes of an SE determination, different technological characteristics means, with respect to a device 
being compared to a predicate device, that there is a significant change in the materials, design, energy source, or 
other features of the device from those of the predicate device. Section 513(i)(1)(B) of the FD&C Act. 
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64  commercial distribution until FDA issues an order stating that the device has been determined to 
65  be SE (section 513(f)(1) of the FD&C Act).5 
66   
B.  510(k) Modernization 
67 
68  In April 2018, CDRH issued the Medical Device Safety Action Plan: Protecting Patients, 
69  Promoting Public Health6 (herein referred to as the Safety Action Plan) to communicate 
70  CDRHs vision for modernizing measures to improve the safety of medical devices while 
71  continuing to create more efficient pathways to bring critical devices to patients. The Safety 
72  Action Plan describes the efforts underway to modernize the 510(k) program.  
73   
74  In November 2018, FDA announced transformative new steps to modernize FDAs 510(k) 
75  program to advance the review of the safety and effectiveness of medical devices. In connection 
76  with this announcement, FDA also requested public feedback on these steps to continue to 
77  modernize the framework for 510(k) review while promoting innovation and improving safety 
78  by driving innovators toward reliance on more modern predicate devices or objective 
79  performance criteria when they seek to bring new devices to the market and ultimately to 
80  patients. FDA indicated that it is looking at ways to promote the use of more recent predicates 
81  because it believes that newer devices should be compared to the benefits and risks of more 
82  modern technology.  
83   
84  To advance these goals, FDA discussed several potential options for 510(k) modernization. The 
85  statement discussed that the Agency considered making public on its website those cleared 
86  devices that demonstrated substantial equivalence to older predicate devices. FDA also 
87  considered focusing on predicates that were more than ten (10) years old as a starting point, so 
88  the public was made aware of those technologies. FDAs goal in focusing on older predicates 
89  was to encourage manufacturers to continually offer patients devices with the latest 
90  improvements and advances. FDA issued a public notice on January 22, 20197 on FDAs website 
91  that requested public comment on this proposal. 
92   
93  FDA reviewed all comments submitted to the docket and acknowledges that the initial proposal 
94  of focusing only on older predicates may not optimally promote safer and more effective 
95 devices. For example, if selecting a predicate for an implant, older devices may potentially have
96 long-term safety and effectiveness datathat establishes ahistory of safe and effective use. 
97 Conversely, when selecting a predicate for a device that includes software, a more recently 
5Under section 510(k) of the FD&C Act, premarket notification is required for devices that are not subject to a 
premarket approval application, unless the device is exempt from the 510(k) requirements of the FD&C Act and 
does not exceed the limitations of exemptions for each of the device classification regulations (e.g., 21 CFR Parts 
862-892).
6Available athttps://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-
promoting-public-health.
7Available athttps://wayback.archive-
it.org/7993/20190206202131/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco
/CDRH/CDRHReports/ucm604500.htm. Public comments submitted can be searched under the docket FDA-2018-
N-4751, available at https://www.regulations.gov/docket/FDA-2018-N-4751/comments.
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98  cleared device could include modern safety features due to rapid technological advances that 
99  affect cybersecurity, interoperability, and modern software architectures.  
100   
101  After considering the docket comments, FDA believes that it may be more appropriate to 
102  modernize the 510(k) process with respect to the use of predicate devices by focusing on 
103  utilizing best practices when selecting a predicate device rather than just their age. Therefore, 
104  FDA is issuing this draft guidance to propose ways to encourage the use of best practices when 
105  selecting a predicate device.  
106   
107  FDA developed this draft guidance to propose factors for consideration as best practices for 
108  choosing a predicate device. These best practices include consideration of the characteristics of 
109  predicate devices rather than focusing on the age of the predicate. FDA believes that this will 
110  encourage the evolution of safer and more effective medical devices in the 510(k) program over 
111  time. Additionally, FDA believes that identification of the characteristics of predicate devices 
112  used to support a 510(k) submission in the accompanying 510(k) Summary may provide 
113  additional transparency to the public for devices subject to 510(k) requirements.8 
114   
III.  Scope 
115 
116  This guidance provides recommendations to industry and FDA staff about the best practices of 
117  choosing a predicate device for a 510(k) submission. This guidance is intended to be used in 
118  conjunction with the 510(k) Program Guidance.9 The recommendations provided in this 
119  guidance are not intended to propose any changes to applicable statutory and regulatory 
120  standards, such as how FDA evaluates substantial equivalence, or the applicable requirements, 
121  including the requirement for valid scientific evidence. FDA developed this guidance to improve 
122  the predictability, consistency, and transparency of the 510(k) premarket review process. 
123   
124  This guidance is also not intended to supplant existing device-specific guidance but may cover 
125  broader areas not addressed in device-specific guidances. 
126   
IV.  How to use this guidance 
127 
128  This guidance is intended to guide submitters through the best practices in selecting a predicate 
129  device for a 510(k) submission. This guidance is intended to be used while a submitter is 
130 preparing their 510(k) submission to assist with the identification ofpotential predicatedevice(s)
131 to support their devices substantial equivalence to a legally marketed device.Based on FDAs 
132 experience in reviewing 510(k) submissions, the Agency is aware that many submitters include 
8Consistent with the 510(k) Program Guidanceand as specified in 21 CFR 807.92(a)(6), the 510(k) Summary shall 
contain the following information: If the device has the same technological characteristics (i.e., design, material, 
chemical composition, energy source) as the predicate device identified in [21 CFR 807.92(a)(3)], a summary of the 
technological characteristics of the subject device in comparison to those of the predicate device. If the device has 
different technological characteristics from the predicate device, a summary of how the technological characteristics 
of the device compare to a legally marketed device identified in [21 CFR 807.92(a)(3)].
9Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k. 
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133  in their 510(k) submission a completed 510(k) flowchart with a discussion describing why the 
134  submitter believes their device is substantially equivalent to the predicate device.10 
135   
136  When considering the selection of predicate devices during 510(k) submission preparation, 
137  submitters should consider the list of legally marketed devices that they believe have the same 
138  intended use as the subject device and when any differences in technological characteristics do 
139  not raise different questions about safety and effectiveness, hereafter referred to as a valid 
140  predicate device.11, 12 FDA recommends narrowing this list of valid predicate device(s) to the 
141 predicate device13 identified by the submitter to support the 510(k) submission using the best 
142 practicesoutlined in Section Vofthis guidance,in conjunction with the 510(k) Program 
143 Guidance.14 A visual representation of this concept is illustrated in Figure 1 below. 
144
145
10For example, FDA has guidance on the Format for Traditional and Abbreviated 510(k)s, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-
510ks. Submitters could include such an assessment in Section 12 (Substantial Equivalence Discussion) of their 
510(k) submission. 
11Consistent with sections 510(k), 510(n), and 513(i) of the FD&C Act and the 510(k) Program Guidance, while 
submitters propose a predicate device in their 510(k) submission, FDA determines whether a subject and predicate 
device are substantially equivalent. This determination includes whether a valid predicate device exists for the 
subject device.
12Consistent with the 510(k) Program Guidance, if FDA has established special controls applicable to the device 
type, the 510(k) would also need to demonstrate that the proposed device meets the relevant special controls for the 
device to be classified into class II.
13Consistent with the 510(k) Program Guidance, a submitter may use multiple predicate devices to help demonstrate 
substantial equivalence in certain circumstances. Submitters sometimes choose to do this when combining features 
from two or more predicate devices with the same intended use into a single new device, when seeking to market a 
device with more than one intended use, or when seeking more than one indication for use under the same intended 
use. Additionally, while FDA does not consider reference devices to be predicate devices, reference devices can be 
used to support a 510(k) submission beyond Decision 4 in the 510(k) flowchart (See Appendix A in the 510(k) 
Program Guidance). For example, reference devices can be used to support scientific methodology or standard 
reference values at Decision 5a in the 510(k) flowchart.
14Available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k.
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146 
147  Figure 1. Visual depiction of the relevant terminology used in this guidance. 
148   
149  FDA recommends the submitter include within their 510(k) submission how they used the best 
150  practices identified in this guidance in selecting the predicate device(s) used to support the 
151  510(k) submission. For example, if a valid predicate device consistent with the best practices 
152  identified in this guidance is not available, FDA recommends describing in the 510(k) 
153  submission how any known concerns with the valid predicate device have been mitigated with 
154  the subject device (e.g., design features, performance testing). FDA also recommends that the 
155  submitter summarize how the best practices were utilized in the selection of the predicate device 
156  used to support the 510(k) submission in the 510(k) Summary (See Section VI of this guidance). 
157  These recommendations are intended to aid the submitter in selecting a predicate for their device 
158  and help provide additional transparency to the public in the 510(k) summary if the 510(k) 
159  submission is cleared by FDA. 
160   
V.  Best practices for selecting a predicate device 
161 
162  FDA identifies all devices cleared through the 510(k) process in the publicly available FDA 
163 510(k) Premarket Notification Database.15 This online database is updated monthly by FDA.
164 Most submitters likely start with basic administrative information to identify valid predicate 
165 device(s), including but not limited to the:
166  Trade names of similar devices;
167  Manufacturer(s) of similar devices;
168  510(k) numbers for similar devices; and
169  Searching of classification information (e.g., product codes, classification regulation) for 
170 similar devices.
171
15Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
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172  Once legally marketed devices have been identified, FDA recommends reviewing the publicly-
173  available 510(k) Summary16 and Indications for Use documents for each device being considered 
174  by the submitter as a valid predicate device. In addition to these basic administrative items, FDA 
175  recommends submitters apply the best practices identified below when selecting a predicate 
176  device to support the 510(k) submission. 
177   
A. Predicate devices cleared using wellestablished methods 
178 
179  FDA recommends selecting a valid predicate device that was cleared using well-established 
180  methods.17 These methods include those from a currently FDA-recognizedvoluntary consensus 
181  standard,18 an FDA guidancedocument,19 a qualified medical device development tool 
182  (MDDT),20 or a widely available and accepted method published in the public domain or 
183  scientific literature for the context of use, or found acceptable through the submitters own 
184  previous premarket submission. FDA recommends prioritizing predicate devices with methods 
185  developed within a consensus environment, and those subject to public comment or peer review. 
186  FDA believes that when selecting a valid predicate device, submitters should consider how much 
187  information is available regarding the test method(s) used in support of the predicate devices 
188  510(k) clearance and whether those methods continue to be appropriate for evaluating the subject 
189  device. For example, voluntary consensus standards periodically undergo revisions and the 
190  methods used to evaluate devices can change with both industry and FDA experience with a 
191  device. 
192   
193  Once the submitter has identified a list of valid predicate devices, FDA recommends conducting 
194  a search of the nonclinical tests submitted, referenced, or relied on in the 510(k) submission21 to 
195 support a determination of substantial equivalence.For example,when selecting between two
196 similar valid predicate devices, where one identified performing testing using FDA guidance and 
16As specified in 21 CFR 807.87(h), a 510(k) Statement as described in 21 CFR 807.93 may be provided by the 
submitter in lieu of a 510(k) Summary. However, in order to facilitate transparency, FDA encourages all submitters 
to utilize the 510(k) Summary option.
17FDA acknowledges this information may not always be publicly available for a predicate device, especially for 
those that were not recently cleared. 
18For the current edition of FDA-recognized standard(s), see the Recognized Consensus Standards Database, 
available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information 
regarding use of consensus standards in regulatory submissions, refer to the FDA guidance titled Appropriate Use 
of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices.
19A list of FDA guidance documents is available on FDAs website at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents.
20A list of qualified MDDTs is available on FDAs website at https://www.fda.gov/medical-devices/medical-
device-development-tools-mddt.
21In accordance with 21 CFR 807.92(a)(3), the 510(k) Summary must identify the predicate relied upon for a 
substantial equivalence determination. In accordance with 21 CFR 807.92, FDA describes the requirements and 
recommendations of the content to be included in a 510(k) Summary in Appendices B and C of the 510(k) Program 
Guidance. 510(k) Summaries for devices that have been cleared for marketing through the FDA can be found in the 
510(k) Premarket Notification Databaseon the FDA website at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
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197  FDA recognized voluntary consensus standards while the other did not, FDA recommends the 
198  submitter select the valid predicate device in which testing relied on these well-established 
199  methods. FDA considers it a best practice to select a predicate that was cleared using well-
200  established methods, as this will continue to advance the 510(k) Program, by encouraging the 
201  evolution of safer and more effective medical devices in the 510(k) program over time, and 
202  ensure that the subject device is evaluated using updated scientific methods whenever possible. 
203   
B. Predicate devices meet or exceed expected safety and 
204 
performance 
205 
206  FDA considers it a best practice to select a valid predicate device that continues to perform 
207  safely and as intended by the manufacturer during use in its intended environment of use 
208  whenever possible. FDA recommends selecting a valid predicate device after considering how 
209  any reported medical device-related adverse events, malfunctions, or deaths may have a role in 
210  the safety and effectiveness of the device. New information about a devices safety and/or 
211  effectiveness, including unanticipated adverse events, may become available once the device is 
212  more widely distributed and used commercially. Also, subsequent changes made to the device, 
213  including material changes, or its manufacturing process may lead to unanticipated effects that 
214  cannot be comprehensively captured during premarket review.22 This new information may 
215  include, but is not limited to, a newly recognized type of adverse event associated with a medical 
216  device, an increase in the severity or frequency of a known adverse event, new product-product 
217  interactions, or device malfunctions. 
218   
219  Once the submitter has identified a list of valid predicate devices, FDA recommends conducting 
220  a search for any reported injury, deaths, or malfunctions using the following FDA databases: 
221    Manufacturer and User Facility Device Experience (MAUDE) Database;23 
222    Medical Device Reporting (MDR) Database;24 and 
223    MedSun Reports Database.25 
224   
225  FDA recommends searching each of the above databases for any reports of unexpected injury, 
226  deaths, or malfunctions associated with the available valid predicate devices. For example, when 
227  selecting a predicate device for an infusion pump, if the database search reveals a high frequency 
228 of reports of battery failures related to the predicate device that resulted in serious injuries to the 
229 operator,such events could suggest fundamental design issues with this valid predicate device
230 and FDA recommends selection of a different valid predicate device for the 510(k) submission 
22The regulatory criteria for when a premarket notification submission is required for a change to an existing device 
are outlined in 21 CFR 807.81(a)(3). For more information regarding when a premarket modification submission is 
required refer to the FDA guidance titled, Deciding When to Submit a 510(k) for a Change to an Existing Device, 
available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-change-existing-device, and the FDA guidance titled, Deciding When to Submit a 510(k) for a Software 
Change to an Existing Device, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/deciding-when-submit-510k-software-change-existing-device.
23Available athttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
24Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm.
25Available athttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/searchreporttext.cfm.
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231  whenever possible. If another valid predicate device is not available, FDA recommends that the 
232  submitter describe in the 510(k) submission how the subject device mitigates the known 
233  concerns with the predicate device used to support the 510(k) submission.  
234   
C. Predicate devices without unmitigated userelated or design
235 
related safety issues 
236 
237  FDA recommends selecting a valid predicate device that does not have unmitigated use-related 
238  or design-related safety issues, including consideration of emerging signals or safety 
239  communications.26 New information about a devices safety and/or effectiveness can become 
240  available once the device is more widely distributed and used. This new information could 
241  represent a signal and may include information related to device malfunctions or patient injuries 
242  potentially related to improper device use or design.  
243   
244  Consistent with the FDA guidance Public Notification of Emerging Postmarket Medical Device 
245  Signals (Emerging Signals),27 an emerging signal is new information about a device that 
246  supports a new causal association or a new aspect of a known association between a device and 
247  an adverse event or set of adverse events and for which FDA has conducted an initial evaluation 
248  and determined that the information has the potential to impact patient management decisions 
249  and/or the known benefit-risk profile of the device. An emerging signal may be associated with 
250  one product from one manufacturer, one type of product or similar products from multiple 
251  manufacturers, or multiple different product types from multiple different manufacturers (e.g., 
252  materials issues). Information about emerging signals and safety communications is available on 
253  the Medical Device Safety28 and CBER Safety & Availability (Biologics)29 websites. FDA 
254  recommends reviewing any safety signals, emerging signals, or other safety information 
255  available prior to selecting a valid predicate device to support the 510(k) submission. 
256   
257  Once the submitter has identified a list of valid predicate devices, FDA recommends conducting 
258  a search of the Medical Device Safety and CBER Safety & Availability (Biologics) websites to 
259  assess whether any of the valid predicate devices have an associated use-related or design-related 
260  safety issue. For example, a signal was reported for duodenoscopes describing challenges in the 
261  adequacy of reprocessing instructions that resulted in a potential for disease transmission.30 This 
262 signal resulted in an effort to replace traditionally reprocessed duodenoscopes with 
263 duodenoscopes which had innovative designs to enhance safety, including designs with 
264 disposable caps or distal ends. FDA considers it a best practice to select avalid predicate device 
265 that is not associated with emerging signals or safety communications that relate to unmitigated 
266 use-relatedor design-related safety issueswhenever possible.
267
26Available at https://www.fda.gov/medical-devices/medical-device-safety.
27Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-notification-
emerging-postmarket-medical-device-signals-emerging-signals.
28Available at https://www.fda.gov/medical-devices/medical-device-safety.
29Available athttps://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics. 
30Available at https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-
designs-enhance-safety-fda-safety-communication.
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D.Predicate devices without an associated designrelated recall 
268
269  FDA recommends selecting a valid predicate device that has not been subject to a design-related 
270  recall.31 Recalls are typically voluntary actions taken by a manufacturer or may be requested by 
271  FDA to correct or remove a violative product from the market.32 A violative product is one in 
272  violation of the laws that FDA administers and against which FDA would initiate legal action. 
273  Recalls can occur dueto design defects, manufacturing defects, or labeling defects.  
274   
275  Design-related recalls can indicate a fundamental flaw with the design of the device as cleared 
276  and commercially distributed. Design controls under 21 CFR 820.30 include a framework that 
277  requires manufacturers subject to these requirements to establish and maintain procedures to 
278  control the design of the device in order to ensure that specified design requirements are met.33,34 
279  When a design-related recall has been conducted for a device, adequate design control 
280  procedures, including but not limited to design input, output, verification, validation, and transfer 
281  may not have been adequately implemented through the design process. In some instances, the 
282  underlying root cause of the design related issues identified as part of a design-related recall may 
283  not be available or a correction of these design-related issues may not be possible. Further, 
284  although the methods and performance data provided in the 510(k) submission for the valid 
285  predicate device subject to a subsequent design-related recall were sufficient to support a 
286  substantial equivalence determination at that time of 510(k) clearance, utilization of such a valid 
287  predicate device may not be ideal to use for future 510(k) submissions. 
288   
289  Once the submitter has identified a list of valid predicate devices, FDA recommends conducting 
290  a search of the Medical Device Recalls Database to assess whether any of the valid predicate 
291  devices have an associated recall. For example, the recall of a coronary catheter tip for fracture 
292 could be associated with a change in the manufacturing process or with the materials used in the 
293 design of the catheter. If a recall is associated with the materials used in the catheter, this could 
294 be considered a design-related recall when it is due to an inadequacy of that material to meet user 
31The Medical Device Recalls Databaseis available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm, and includes recalls classified since November 
2002.
32While FDA focuses on voluntary recalls conducted under 21 CFR Part 7, FDA may, after providing the 
appropriate person with an opportunity to consult with the Agency, also require that a manufacturer recall their 
device when the criteria are met under 21 CFR Part 810.
33For devices subject to 510(k) requirements, design controls apply to class II devices and those class I devices 
listed in 21 CFR 820.30(a)(2).
34On February 23, 2022, FDA proposed to amend the device Quality System Regulation, 21 CFR Part 820, to align 
more closely with international consensus standards for devices (87 FR 10119; available at
https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-
amendments). Specifically, FDA proposed to withdraw the majority of the current requirements in Part 820 and 
instead incorporate by reference the 2016 edition of the International Organization for Standardization (ISO) 13485, 
Medical devices  Quality management systems for regulatory purposes, in Part 820. As stated in that proposed rule, 
the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current 
Part 820, providing a similar level of assurance in a firms quality management system and ability to consistently 
manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. FDA intends to 
finalize this proposed rule expeditiously. When the final rule takes effect, FDA will also update the references to 
provisions in 21 CFR Part 820 in this guidance to be consistent with that rule.
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295  needs and intended uses. The material used in the design of this catheter and the testing 
296  conducted on the predicate device did not adequately mitigate against the risk of tip fracture, 
297  resulting in a design-related recall. FDA considers it a best practice to select a valid predicate 
298  device that is not associated with a design-related recall whenever possible. 
299   
VI.  Improving the Transparency of Predicate Devices 
300 
301  The 510(k) Summary is a document that provides an adequate summary of any information 
302  respecting safety and effectiveness and must include all the elements identified in 21 CFR 
303  807.92.35 A 510(k) Summary must be in sufficient detail to provide an understanding of the basis 
304  for a determination of substantial equivalence (21 CFR 807.92(a)). In Appendix B of the 510(k) 
305  Program Guidance, FDA describes the requirements of the content to be included in a 510(k) 
306  Summary, in accordance with 21 CFR 807.92, and provides recommendations on the 
307  information to be included in a 510(k) Summary to ensure compliance with 21 CFR 807.92 and 
308  consistency in the level of information conveyed and captured in the 510(k) Summaries that are 
309  available to the public on FDAs website. 
310   
311  In an effort to improve the transparency and predictability of the 510(k) program and to ensure 
312  that the 510(k) Summary reflects the information provided in a 510(k) submission to support a 
313  substantial equivalence determination, FDA stated in the 510(k) Program Guidance that the 
314  Agency intends to verify the accuracy and completeness of the information included in a 510(k) 
315  Summary.  
316   
317  Although the 510(k) Summary is a document drafted by the submitter and is included in the 
318  510(k), revisions to the 510(k) Summary may be necessary to accurately reflect FDAs decision-
319  making process. As stated in the 510(k) Program Guidance, and consistent with 21 CFR 
320  807.92(b)(1), 510(k) Summaries shall include a brief discussion of the nonclinical tests 
321  submitted, referenced, or relied on in the premarket notification submission for a determination 
322  of substantial equivalence.  
323   
324  FDA recommends that submitters include a narrative explaining their selection of the predicate 
325  device(s) used in support of the 510(k) submission in their draft 510(k) Summary submitted with 
326  their original 510(k).36 FDA recommends this narrative include a discussion of how the best 
327  practices described in Section V of this guidance were used to select the predicate device(s) 
328 proposed for use in the 510(k) submission. This recommendation is intended to promote 
329 transparency to the public regarding the process ofselecting apredicate device using thesebest 
330 practices.
331
332 When a submitter cannot identify a valid predicate device(s)that is consistent with any of the 
333 best practicesdiscussed in Section Vof this guidance, FDA recommends that the submitter
35As specified in 21 CFR 807.87(h), a 510(k) Statement as described in 21 CFR 807.93 may be provided in lieu of a 
510(k) Summary. However, in order to facilitate transparency, FDA encourages all submitters to utilize the 510(k) 
Summary option.
36As described in Appendix C of the 510(k) Program Guidance, this information is provided in the Comparison of 
Technological Characteristics with the Predicate Device of the 510(k) Summary.
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334  include a statement in their 510(k) Summary that a valid predicate that is consistent with the best 
335  practices was not available. FDA recommends that the submitter also use the Performance Data 
336  Section of the 510(k) Summary to describe the ways performance testing was conducted to 
337  address any known safety or effectiveness concerns with the predicate device used to support the 
338  510(k) submission.37 
339   
VII. Examples 
340 
341  The following are illustrative examples that are intended to exemplify how the best practices 
342  identified in Section V of this guidance for selecting a valid predicate device can be used. These 
343  examples do not necessarily account for every possible detail, risk, or consideration that a 
344  submitter should consider when selecting the predicate device used in support of the 510(k) 
345  submission. These examples also include different formats that could be used depending on the 
346  number of valid predicate devices available for use to support the 510(k) submission. 
347   
348     
349  A submitter is preparing a 510(k) submission for a coronary guidewire, Guidewire X. The 
350  submitter identified four valid predicate devices, all of which have the same intended use as 
351  Guidewire X and any differences in technological characteristics do not raise different questions 
352  of safety and effectiveness. The submitter included the following table in their 510(k) 
353 submission, along with their rationale for selecting Predicate 4 as thepredicate deviceused to 
354 support their 510(k) submission:
355
37Section 518A of the FD&C Act directs FDA to establish a program to routinely and systematically assess 
information regarding device recalls, and to use that information to proactively identify strategies for mitigating 
health risks presented by defective or unsafe devices. Consistent with the 510(k) Program Guidance, FDA believes 
that providing greater transparency on recalled devices is one way to help achieve this directive.
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Valid  A  Well- B  Meets or  C   D  Associated 
Predicate  established  exceeds expected  Unmitigated  design-related 
Device methods predicate  use-related or  recall
performance design-related 
safety issues
1 Used internal  High frequency of  Safety  No design-
methods that are not  fractures reported in  communication  related recall 
widely available and  MDRs/MedSun  found on FDAs  identified
accepted reports website
2 Used relevant  Expected frequency  No known  Design-related 
methods that were  of reported adverse  unmitigated use- recall identified 
published in the  events related or design- in FDAs 
public domain related safety  database
issues
3 Used outdated  Expected frequency  No known  No design-
methods in a  of reported adverse  unmitigated use- related recall 
subsequently  events related or design- identified
superseded FDA  related safety 
guidance document issues
4 Used updated  Expected frequency  No known  No design-
methods from  of reported adverse  unmitigated use- related recall 
current FDA  events related or design- identified
guidance document related safety 
issues
356 
357  In their draft 510(k) Summary, the submitter includes a brief narrative describing the above 
358  selection process in the proposed 510(k) Summary. The submitters draft 510(k) Summary also 
359  includes a discussion that the selected predicate used well-established methods from a current 
360  FDA guidance document, discusses the frequency of reported adverse events, and states that 
361  there are no known unmitigated use-related or design-related safety issues or design-related 
362  recalls. 
363   
364     
365  A submitter is preparing a 510(k) submission for a bone sonometer, Bone Sonometer X. The 
366  submitter identified only one valid predicate device, which has the same intended use as bone 
367  sonometer X and any differences in technological characteristics do not raise different questions 
368  of safety and effectiveness. The valid predicate device, Predicate 1, used the currently FDA-
369  recognized versions of applicable consensus standards, has an expected frequency of reported 
370  events, had no known unmitigated use-related or design-related safety issues before submission 
371  of the device-related recall, but has been associated with a design-related recall.  
372   
373  The submitter referenced Predicate 1 as their predicate device in their 510(k) submission, along 
374  with a statement that Predicate 1 was the only valid predicate device that could be identified. The 
375 submitter also described the ways performance testing was conducted to address the safety 
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376  concerns relevant to the design-related recall associated with Predicate 1 and the measures taken 
377  to mitigate those safety concerns in the subject device. 
378   
379  In their draft 510(k) Summary, the submitter identified that the predicate device used to support 
380  the 510(k) submission has been the subject of a design-related recall, but also included a brief 
381  narrative describing the selection process in the proposed 510(k) Summary. The sponsor also 
382  included a summary of how their performance testing provided in the 510(k) addressed the safety 
383  concerns relevant to Predicate 1s design-related recall in the Performance Data section of the 
384  draft 510(k) Summary. 
385   
386     
387  A submitter is preparing a 510(k) submission for an intervertebral fusion device (IFD), IFD X. 
388  The submitter identified two valid predicate devices, both of which have the same intended use 
389  as IFD X and any differences in technological characteristics do not raise different questions of 
390  safety and effectiveness. Predicate 1 has been on the market for 15 years and Predicate 2 has 
391  been on the market for 3 years and both devices are still in clinical use. The submitter included 
392  the following table in their 510(k) submission, along with their rationale describing that while 
393  Predicate 2 also uses the best practices for selecting a predicate device, Predicate 1 was selected 
394  as the predicate device used to support the 510(k) submission because it has a well-established 
395  safety profile due to a longer duration of device use. 
396   
Valid  A  Well- B  Meets or exceeds  C   D  Associated 
Predicate  established  expected predicate  Unmitigated  design-related 
Device methods  performance  use-related or  recall 
design-related 
safety issues 
1  Used relevant  Expected frequency of  No known  No design-
methods that  reported adverse  unmitigated use- related recall 
were published  events. History of safe  related or  identified 
in the public  use established due to  design-related 
domain  duration of device on  safety issues 
the market. 
2  Used relevant  Expected frequency of  No known  No design-
methods that  reported adverse events  unmitigated use- related recall 
were published  related or  identified 
in the public  design-related 
domain  safety issues 
397   
398  In their draft 510(k) Summary, the submitter includes a brief narrative describing the above 
399  selection process in the proposed 510(k) Summary. The submitters draft 510(k) Summary also 
400  includes a discussion that the predicate used to support the 510(k) submission used well-
401  established methods for IFDs, discusses the frequency of reported adverse events, including that 
402 the device has a well-established safety profile through a history ofsafe use due to its longer 
403 duration on the market, and states that there are no known unmitigated use-relatedor design-
404 related safety issues or associated design-related recalls.
14