Contains Nonbinding Recommendations
Refuse to Accept Policy for 510(k)s
Guidance for Industry and 
Food and Drug Administration Staff
Document issued on: April 21, 2022.
Document originally issued on May 20, 1994.
This document supersedes Refuse to Accept Policy for 510(k)s issued 
September 13, 2019.
For questions about this document regarding CDRH-regulated devices, contact ORP: Office of 
Regulatory Programs, DRP1: Division of Submission Support, Premarket Notification and 
Classification Team by email at 510K_Program@fda.hhs.gov or at 301-796-5640.
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) by email at ocod@fda.hhs.gov or at 800-
835-4709 or 240-402-8010.
OMB Control No. 0910-0120
Current expiration date available at https://www.reginfo.gov 
See additional PRA statement in Section IX of this guidance
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
1 Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 
Identify all comments with the docket number FDA-2012-D-0523. Comments may not be acted 
upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 1793 and complete title of the guidance in the request. 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20903, or by calling 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.
2 Contains Nonbinding Recommendations
Table of Contents
I. Purpose ........................................................................................................................................ 4
II. Background ................................................................................................................................ 5
III. Scope ......................................................................................................................................... 6
IV. Q-submission Interaction .......................................................................................................... 6
V. 510(k) Refuse to Accept Policies and Procedures ..................................................................... 7
VI. Refuse to Accept Principles .................................................................................................... 10
VII. The Checklist  Preliminary Questions ................................................................................. 12
VIII. The Checklists  Acceptance Review .................................................................................. 14
IX. Paperwork Reduction Act of 1995 ......................................................................................... 19
Appendix A. Acceptance Checklist for Traditional 510(k)s ................................................... 20
Appendix B. Acceptance Checklist for Abbreviated 510(k)s .................................................. 55
Appendix C. Acceptance Checklist for Special 510(k)s ........................................................... 91
3 Contains Nonbinding Recommendations
Refuse to Accept Policy for 510(k)s
Guidance for Industry and 
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic. It does not establish any rights for any person and is not binding 
on FDA or the public. You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations. To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page. 
I. Purpose
The purpose of this document is to explain the procedures and criteria FDA intends to use in 
assessing whether a premarket notification (510(k)) submission meets a minimum threshold 
of acceptability and should be accepted for substantive review.
Focusing FDAs review resources on complete submissions will provide a more efficient 
approach to ensuring that safe and effective medical devices reach patients as quickly as 
possible. Moreover, with the enactment of the Medical Device User Fee and Modernization 
Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II), 
the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device 
User Fee Amendments of 2017 (MDUFA IV),1 FDA agreed to performance goals based on 
the timeliness of reviews. Acceptance review therefore takes on additional importance in 
both encouraging quality submissions from submitters of 510(k) notifications and allowing 
FDA to appropriately concentrate resources on complete submissions.
Therefore, the current 510(k) Refuse to Accept (RTA) policy includes an early review 
against specific acceptance criteria and to inform the submitter within the first 15 calendar 
days after receipt of the submission if the submission is administratively complete, or if not, 
to identify the missing element(s). In order to enhance the consistency of our acceptance 
decisions and to help submitters better understand the types of information FDA needs to 
conduct a substantive review, this guidance, including the checklists included in the 
appendices, clarify the necessary elements and contents of a complete 510(k) submission. 
The process we outline is applicable to all devices reviewed through the 510(k) notification 
process and has been compiled into checklists for use by FDA review staff.
It is critical to distinguish between the completeness of the regulatory submission, and the 
1 See Title II of the FDA Reauthorization Act of 2017 (Public Law 115-52).
4 Contains Nonbinding Recommendations
quality of the data provided and any studies conducted in support of the submission. The 
assessment of the completeness of the 510(k) occurs during the acceptance review, while the 
assessment of the quality of the submitted information occurs during the substantive review. 
FDA will base acceptance on the objective criteria outlined in the associated Acceptance 
Checklist and not on the quality of the data.
The contents of this document do not have the force and effect of law and are not meant to 
bind the public in any way, unless specifically incorporated into a contract. This document is 
intended only to provide clarity to the public regarding existing requirements under the law. 
FDA guidance documents, including this guidance, should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidance means that something is suggested or recommended, 
but not required.
II. Background
The purpose of the 510(k) acceptance review is to assess whether a submission is 
administratively complete, in that it includes all of the information necessary for FDA to 
conduct a substantive review and to reach a determination regarding substantial equivalence 
under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States 
Code (U.S.C.)  360c(i)). To find a device substantially equivalent under section 513(i) of 
the FD&C Act, FDA must find that it has the same intended use as the predicate device, and 
either (1) has the same technological characteristics as the predicate device, or (2) has 
different technological characteristics, as defined at section 513(i)(1)(B), and the submission 
contains information, including appropriate clinical or scientific data if necessary, that 
demonstrates the device is as safe and effective as the predicate and does not raise different 
questions of safety and effectiveness than the predicate.
The 510(k) regulations at 21 CFR 807.87 to 807.100 provide greater detail regarding the 
specific information that each premarket notification submission must contain. For example, 
the submission must include proposed labeling (807.87(e)), a statement regarding the 
similarities and differences between the device and others of comparable type (807.87(f)), 
supporting data (807.87(f) and 807.100(b)(2)(ii)(B)), and FDA may request any additional 
information necessary to determine whether the device is substantially equivalent when the 
information provided is insufficient to enable such a determination (807.87(m)). Please also 
refer to our guidance document entitled, Format for Traditional and Abbreviated 510(k)s.2
Prior guidances and checklists relating to 510(k) RTA policy (i.e., 510(k) Refuse to Accept 
Policy, dated June 30, 1993, and 510(k) Refuse to Accept Procedures (K94-1) blue book 
memo, dated May 20, 1994) focused on defining broad issues or principles. Additionally, the 
checklists associated with these guidances dealt largely with administrative elements but did 
not address specific content that is essential for 510(k) review. As a result, FDA had accepted 
many inadequate submissions for review, and FDA staff invested significant time in 
2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks. 
5 Contains Nonbinding Recommendations
constructing extensive letters requesting all of the additional information needed to conduct a 
substantive review. This approach was an inefficient use of resources and frequently 
lengthened review times. For additional information see CDRHs Analysis Of Premarket 
Review Times Under The 510(k) Program.3
The goal of the guidance titled Refuse to Accept Policy for 510(k)s, dated December 31, 
2012 was to clarify the content needed in Traditional, Abbreviated, and Special 510(k) 
submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of 
received 510(k) submissions and improving overall review time. The review process 
presented in this document is captured in the Acceptance Checklists for Traditional, 
Abbreviated, and Special 510(k) submissions, which FDA staff will use during the 
acceptance review process.
III. Scope
The information presented in this document is intended to provide FDA staff with a clear, 
consistent approach for acceptance review for Traditional, Abbreviated, and Special 510(k) 
notifications and to outline the RTA policy on 510(k)s. It will also help submitters prepare 
510(k) notifications that are administratively complete for FDA to conduct a substantive 
review. 
The acceptance policy does not alter the substantial equivalence decision-making process 
once the submission has been accepted for review; however, it does alter the start of the FDA 
review clock for purposes of MDUFA performance goals for those submissions that are not 
accepted for review. More information regarding FDAs review clock is provided in Section 
V of this document. 
This document does not address the monetary aspects or the MDUFA goals associated with
510(k)s. Information pertaining to the fees and payment procedures for submission of a 
510(k) notification can be found in FDAs guidance document User Fees and Refunds for 
Premarket Notification Submissions (510(k)s).4
IV. Qsubmission Interaction
For general information regarding the 510(k) regulations under 21 CFR Part 807, submitters 
should consult CDRHs Division of Industry and Consumer Education (DICE) or CBERs 
Manufacturers Assistance and Technical Training Branch. Before submitting a 510(k) 
notification, we encourage submitters, especially those who are less familiar with the 510(k) 
review program or who have novel issues to address, to interact with the appropriate FDA 
review staff. Such Q-submission interaction is an important way of improving the quality and 
completeness of a 510(k). For additional information regarding the Q-Submission process, 
please refer to the guidance titled Requests for Feedback and Meetings for Medical Device 
3 https://www.fda.gov/media/80972/download. 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-
premarket-notification-submissions-510ks.
6 Contains Nonbinding Recommendations
Submissions: The Q-Submission Program.5
In addition, other FDA guidance documents and resources provide valuable information for 
preparing 510(k)s, including:
 Format for Traditional and Abbreviated 510(k)s;6
 The Special 510(k) Program;7
 The Abbreviated 510(k) Program;8
 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)];9
 eCopy Program for Medical Device Submissions;10
 Types of Communication During the Review of Medical Device Submissions;11
 Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification 
Requirements;12
 Other applicable device-specific and cross-cutting guidance documents;13 and
 CDRH Device Advice.14
V. 510(k) Refuse to Accept Policies and Procedures
FDA staff conduct acceptance reviews of  Traditional, Abbreviated, or Special 510(k)s based 
on objective criteria using the applicable Acceptance Checklist (see Appendices A-C) to 
ensure that the 510(k) is administratively complete. In order for the submission to be 
accepted, all administrative elements identified as RTA items should be present or a rationale 
should be provided for those elements determined by the submitter to be not applicable. To 
aid in the administrative review, it is recommended that submitters complete and submit 
acceptance checklists with their submissions that identify the location of supporting 
information for each RTA element. 
The acceptance review occurs prior to the substantive review and should be conducted and 
completed within 15 calendar days of FDA receiving the 510(k) notification. An acceptance 
review will only begin for 510(k) submissions for which the applicable user fee has been 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
6https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks.
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program.
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k.
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions.
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/types-communication-during-
review-medical-device-submissions.
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intent-exempt-certain-
unclassified-medical-devices-premarket-notification-requirements.
13 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-
documents-medical-devices-and-radiation-emitting-products.
14 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance.
7 Contains Nonbinding Recommendations
paid and a valid eCopy has been received.15
The staff will select the applicable checklist based on the 510(k) type (i.e., Traditional, 
Abbreviated, or Special). The acceptance review will be conducted on original 510(k) 
submissions and responses to RTA communications, but not supplements or amendments 
submitted in response to requests for additional information after a submission has been 
accepted. The staff should assess whether the submission should be accepted by first 
answering the preliminary questions below, and then verifying that the submission contains 
all of the information identified as RTA items in the checklist. 
The purpose of the 510(k) acceptance review is to assess whether a submission is 
administratively complete, in that it includes all of the information necessary for FDA to 
conduct a substantive review. Therefore, the submission generally should not be accepted 
and should receive an RTA designation if one or more of the items noted as RTA items in the 
checklist are not present and no explanation is provided for the omission(s). However, during 
the RTA review, FDA staff has discretion to determine whether missing checklist items are 
needed to ensure that the submission is administratively complete to allow the submission to 
be accepted. FDA staff also has discretion to request missing checklist items interactively 
from submitters during the RTA review. Interaction during the RTA review is dependent on 
FDA staffs determination that outstanding issues are appropriate for interactive review and 
that adequate time is available for the submitter to provide supporting information and for 
FDA staff to assess responses before the Acceptance deadline of 15 days. 
If one or more items noted as RTA items on the Acceptance Checklist are not present and 
FDA staff conducting the acceptance review determine that the submission should be 
refused, FDA staff should obtain management concurrence and notify the designated 510(k) 
contact person electronically16 that the submission has not been accepted.17 FDA staff should 
also provide the submitter with a copy of the completed checklist indicating which item(s) 
are the basis for the RTA designation.
The 510(k) submitter may respond to the RTA notification by providing the missing 
information identified in the checklist. When providing the missing information, the 
submitter should submit this information to be included in the file under the originally 
assigned 510(k) number. A new submission and new user fee are not necessary. Nor is it 
15 See sections 738(a)(2)(A)(viii) and 738(f)(1) of the FD&C Act, section 745A(b) of the FD&C Act, and the 
FDA guidance, eCopy Program for Medical Device Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. Additional information is also provided in the guidance FDA and Industry Actions on Premarket 
Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals, 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. 
16 For additional information about email communications with CBER, please see SOPP 8119: Use of Email for 
Regulatory Communications, available at https://www.fda.gov/media/108992/download.
17 As outlined in the commitment letter for MDUFA III [158 CONG. REC. S8277-S8281 (daily ed. Corrected 
December 20, 2012) (Letters from the Secretary of Health and Human Services Re: Medical Device User Fee 
Program), also available at https://www.fda.gov/media/83244/download], the review clock will not start until 
the 510(k) submission is accepted for review.
8 Contains Nonbinding Recommendations
necessary to re-send the entire 510(k) submission, unless FDA notes otherwise (e.g., because 
the majority of the submission is not in English, or the submission is missing the majority of 
the items on the checklist). It is sufficient to submit and address only the information 
requested in the RTA notification. If a complete response to the RTA notification is not 
received within 180 days of the date of RTA notification, FDA will consider the 510(k) to be 
withdrawn and the submission will be closed in the system. 
Upon receipt of newly submitted information in response to an RTA notification, FDA staff 
should conduct the acceptance review again following the same procedure within 15 calendar 
days of receipt of the new information. This acceptance review will assess whether the new 
information makes the submission complete according to the checklist criteria for 
completeness. If the submission is still found to be incomplete, FDA staff should notify the 
contact person and provide a copy of the new checklist indicating the missing item(s).
When a submission is accepted, FDA staff should electronically notify the submission 
contact person that the 510(k) has been accepted and begin a substantive review of the 
submission to determine substantial equivalence. Should FDA fail or choose not to complete 
the acceptance review within the acceptance review period (i.e., within 15 calendar days of 
receipt), the submitter should be electronically notified that the acceptance review was not 
completed and the submission is under substantive review. FDA may request any 
information that may have resulted in an RTA designation during the substantive review.18
Once a submission has been accepted, FDA may ask for any information during the 
substantive review that may have been unintentionally overlooked during the acceptance 
review.
FDA Review Clock
As explained in the commitment letter for MDUFA IV referenced in Title II of the FDA 
Reauthorization Act of 2017 (Public Law 115-52), FDA days begin on the date of receipt of 
the submission or of the amendment to the submission that enables the submission to be 
accepted (510(k)) or filed (PMA).19 As stated above, an acceptance review will only begin 
for 510(k) submissions for which the applicable user fee has been paid and a valid eCopy has 
been received. Thus, the FDA review clock does not start when a submission is placed on 
eCopy or User Fee hold or designated RTA.
510(k) submissions and additional information submitted in response to a RTA designation 
are received by the respective Centers Document Control Center (DCC). The FDA review 
clock start date is the DCC receipt date of the most recent submission or additional 
information that resulted in an acceptance designation for the 510(k), provided the submission 
user fee has been paid and a validated eCopy has been provided. For example, if the 
18 In the case of a government closure during the 15-day acceptance review period, the review period may be 
extended by a comparable number of business days that the FDA buildings are closed. If the submitter receives 
an automated notice that the acceptance review was not completed because the screening period has exceeded 
15 days, FDA may send a correction notice to the submitter.
19 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. 
9 Contains Nonbinding Recommendations
submission is accepted for substantive review on the first acceptance review, the FDA review 
clock start date is the DCC receipt date of the submission. However, if the submission is 
designated RTA, the FDA review clock start date is not yet known. In such cases, the clock 
start date will be the DCC receipt date of the submission including the additional information 
that results in an acceptance designation (even if FDA later requests information that should 
have been requested during acceptance review). In the event the acceptance review was not 
completed within 15 calendar days, the submission will be considered to be under substantive 
review, and the FDA review clock start date will be the DCC receipt date of the most 
recently received information that was the subject of the acceptance review for the 
submission. Once the submission is under substantive review the calendar days used to 
conduct the acceptance review (i.e., up to 15 days) are included within the 60 calendar days 
to reach the Substantive Interaction goal as described in the aforementioned commitment 
letter for MDUFA IV. 
Notification of Acceptance Review Result
The submitter should receive an electronic notification of the acceptance review result within 
15 calendar days of DCC receipt (i.e., that the submission has been accepted for substantive 
review, that the submission is not accepted for review (RTA), or that the submission is now 
under substantive review because the acceptance review was not completed). The notification 
will be sent only to the designated contact person identified in the submission.This 
 
notification will also serve to identify the FDA 510(k) lead reviewer20 assigned to the 
submission. The notification of either the acceptance or RTA designation will be made only 
with supervisory concurrence of the reviewers acceptance review determination. The 
notification of acceptance or RTA designation may occur on any day prior to the 15th 
calendar day of DCC receipt. However, in the event the acceptance review was not 
completed within 15 calendar days, a notification that an RTA review was not completed will 
be sent on the 16th day. In the case of RTA designation, the notification should be 
accompanied by the completed checklist indicating the missing elements that resulted in the 
RTA designation. The completed checklists are considered part of the submissions 
administrative file and are not posted publicly when FDA makes the RTA designation. 
Therefore, it is imperative that the submission identify complete contact information, 
including the email address to which the notification should be sent.21
VI. Refuse to Accept Principles
In order to use this guidance appropriately, FDA staff should review the following basic 
principles regarding FDAs review policies and procedures.
Acceptance should not be based on a substantive review of the information provided in the 
510(k) notification.
20 In the case of 510(k)s submitted to CBER, whenever the term lead reviewer is used in this guidance, the 
equivalent CBER contact person is the regulatory project manager (RPM). 
21 CBER will accommodate the use of faxes; submitters may also wish to provide a fax number. 
10 Contains Nonbinding Recommendations
It is important to make the distinction between the acceptance review and the substantive 
review. The acceptance review is conducted to assess whether the submission contains all of 
the appropriate elements, as identified in the applicable checklist, in order to begin a 
substantive review. In assessing whether a 510(k) notification should be accepted, submitted 
information is not evaluated for adequacy to support a finding of substantial equivalence. The 
checklist is a tool to ensure that the submission contains the necessary information in order to 
conduct a substantive review (i.e., FDA should not refuse to accept a submission if 
information is present but inadequate to support a finding of substantial equivalence). The 
evaluation of the quality of the content and the substantial equivalence decision making 
process occur within the substantive review once the file has been accepted.
FDA staff should determine whether the submitter provided a justification for any alternative 
approach.
The submitter may provide a rationale for why any criteria in the checklist are not applicable 
to the device. Likewise, the submitter may provide a rationale for any deviation from a 
device- specific or cross-cutting guidance document or FDA-recognized standard. It is 
FDAs expectation that each item in the checklist will be addressed either by including the 
requested information or providing a rationale for why it is not applicable or why there is a 
deviation.
FDA will not consider a given criterion in the checklist to be Present if the submission fails 
to include either the information identified or a rationale for omission or deviation. If a 
justification to omit certain information or for taking an alternative approach is provided, 
FDA will consider the adequacy of that justification or alternative approach during 
substantive review of the submission. See Acceptance Review section below for examples 
and further explanation.
Device-specific and cross-cutting guidance documents, applicable recognized standards, and 
applicable regulations will be considered when making an RTA determination.
Before submitting a 510(k), the submitter should consider the currently available guidance 
documents and standards, as well as applicable regulations for the proposed device in the 
preparation of the submission. FDA staff and industry are encouraged to refer to the product 
classification database22 to assist in identifying any applicable recognized consensus 
standards. If citing voluntary consensus standards, the submitter should consider FDAs 
guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices.23
Specifically, the checklist includes questions regarding whether the submission has addressed 
recommendations regarding the device description, labeling, and performance testing as 
outlined in a device-specific guidance, special controls or another specific regulation. Note 
that addressed means that the submission includes information pertinent to those 
22 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 
23 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices.
11 Contains Nonbinding Recommendations
recommendations or requirements; assessment of the adequacy of that information in 
meeting those recommendations or requirements should be assessed during review. 
If there is a device-specific guidance, other than a special controls guidance document, the 
submission includes information to establish that the submitter has addressed the 
recommendations or otherwise provided an alternative approach intended to address the 
applicable statutory and/or regulatory criteria. 
If there are special controls applicable to the device, the submission includes information 
addressing the particular mitigation measures set forth in the special controls, or uses 
alternative mitigation measures and provides a rationale to demonstrate that those alternative 
measures identified by the submitter will provide at least an equivalent assurance of safety 
and effectiveness.
VII. The Checklist  Preliminary Questions
Within 15 calendar days of receipt of the 510(k), FDA staff should answer the preliminary 
questions below, which are included on the first page of the Acceptance Checklists for 
Traditional and Abbreviated 510(k)s. The preliminary questions are intended to be answered 
by the 510(k) lead reviewer as an initial screening of the submission. FDA does not intend 
for the submitter to have addressed these items in their submission. Depending upon the 
answers to these preliminary questions, the remainder of the acceptance review may or may 
not be necessary.
If the responses to the preliminary questions and subsequent consultation with the Center 
personnel identified below indicate that the 510(k) acceptance review should not continue24
the 510(k) lead reviewer should promptly: 
 inform the 510(k) review team (including consulting reviewers); and
 notify the submitter using proper administrative procedures.
The preliminary questions are:
1.  Is the product a device (per section 201(h) of the FD&C Act) or a combination 
product (per 21 CFR 3.2(e)) with a device constituent part subject to review in a 
510(k)?
If the product does not appear to meet the definition of a device under section 201(h) of 
the FD&C Act, or does not appear to be a combination product with a device constituent 
part, then the 510(k) lead reviewer should consult with the CDRH Product Jurisdiction 
24 FDA will not process a 510(k) unless it meets the following requirements: i) the submission must be sent 
with the user fee required by section 738 of the FD&C Act, and ii) a valid eCopy is provided. See section 
738(a)(2)(A)(viii) and 738(f)(1) of the FD&C Act, section 745A(b) of the FD&C Act, and the FDA guidance,  
eCopy Program for Medical Device Submissions, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/ecopy-program-medical-device-submissions. Because any 510(k) 
not meeting these two requirements will not be processed by the respective Centers DCC, they are not included 
in the checklist.
12 Contains Nonbinding Recommendations
Officer or the CBER Product Jurisdiction Officer to determine the appropriate action, and 
inform management. If FDA staff determines that the product is not a device and is not a 
combination product with a device constituent part, the 510(k) lead reviewer should stop 
the review and notify the submitter.
2.  Is the submission with the appropriate Center?
If the submission is for a single-entity device and appears to be subject to review in a 
Center different from the one to which it was submitted, or if it is for a combination 
product with a device constituent part and it appears that a Center different from the one 
to which it was submitted has the lead, the 510(k) lead reviewer should consult with the 
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to 
determine the appropriate action and inform management. If the 510(k) is submitted to 
CDRH and CDRH staff determines that the submission is not subject to CDRH review, 
or the 510(k) is submitted to CBER and CBER staff determines that the submission is not 
subject to CBER review, the 510(k) review team should stop the review and notify the 
submitter. 
3. If a Request for Designation (RFD) was submitted for the device or combination 
product with a device constituent part and assigned to your center, identify the RFD 
# and confirm the following:
(a) Is the device or combination product the same (e.g., design, formulation) as 
that presented in the RFD submission?
(b) Are the indications for use for the device or combination product identified 
in the 510(k) the same as those identified in the RFD submission?
An RFD determination is specific to the device or combination product and indications 
for use for the device or combination product described in the RFD submission. If the 
device or combination product has been modified or the indications for use have been 
modified since the RFD, the RFD determination may no longer be applicable and 
jurisdiction may need to be reevaluated by the Office of Combination Products (OCP). 
The 510(k) lead reviewer should consult with the CDRH Product Jurisdiction Officer or 
the CBER Product Jurisdiction Officer to determine the appropriate action and inform 
management. 
4. Is the submission for a combination product that contains as a constituent part a 
drug that has the same active moiety as an approved drug with exclusivity as 
described in section 503(g)(5)(C)(ii)-(v) of the FD&C Act?
If the submission is for a combination product and contains as a constituent a drug that 
has the same active moiety as an approved drug with exclusivity as described in section 
503(g)(5)(C)(ii)-(v) of the FD&C Act, the 510(k) lead reviewer should contact the CDRH 
Product Jurisdictional Officer or CBER Product Jurisdiction Officer to determine the 
appropriate action and inform management.
5.  Is this device type eligible for a 510(k) submission?
13 Contains Nonbinding Recommendations
FDA staff should determine whether the 510(k) submission is for a device type for which 
510(k) is known to be an inappropriate regulatory approach, such as when the device type 
is class III type and a PMA is required, or the device type is class I or II and 510(k)-
exempt. If a 510(k) is not appropriate, FDA staff should make this determination during 
the acceptance review and notify the submitter of the determination. This preliminary 
question is not intended to identify submissions for which a substantive review is 
required in order to determine if 510(k) is an inappropriate approach (e.g., device has a 
new intended use or device has different technological characteristics that raise different 
questions of safety and effectiveness). 
6.  Is there a pending PMA for the same device with the same indications for use?
If the submitter has a PMA for the same device with the same indications for use 
pending, the review team should stop the review. The 510(k) review team should consult 
management and other Center resources to determine which premarket review pathway 
applies to the device and the appropriate processes for addressing the situation. FDA staff 
should also consult management and other Center resources if a 510(k) and PMA have 
been submitted for the same device type by different submitters. 
7.  If clinical studies have been submitted, is the submitter the subject of the 
Application Integrity Policy (AIP)?25
The 510(k) lead reviewer should refer to the AIP list.26 If the submitter is on the list, the 
reviewer should consult the CDRH Office of Product Evaluation and Quality/Office of 
Clinical Evidence and Analysis/Division of Clinical Science and Quality 
(OPEQ/OCEA/DCEA1) or CBER Office of Compliance and Biologics Quality/Division 
of Inspections and Surveillance/ Bioresearch Monitoring Branch (OCBQ/DIS/BMB) to 
determine the appropriate action.
VIII. The Checklists  Acceptance Review
Organizational Elements
Although missing one or more of the items in the table of Organizational Elements in the 
Acceptance Checklists, such as a Table of Contents or page numbers, generally will not lead 
to an RTA decision, we strongly encourage submitters to incorporate these elements in their 
submissions to facilitate FDA review and decision-making. If, however, the submission is so 
disorganized that FDA cannot locate the information needed to assess substantial 
25 When data in a pending submission have been called into question by certain wrongful acts (fraud, untrue 
statements of material facts, bribery, or illegal gratuities), FDA intends to defer substantive scientific review of 
such data until completion of a validity assessment and questions regarding reliability of the data are resolved. 
(See FDA Guide 7150.09 Compliance Policy Guide, Chapter 50  General Policy  Subject: Fraud, Untrue 
Statements of Material Facts, Bribery, and Illegal Gratuities, 56 FR 46191).
26 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/application-integrity-
policy/application-integrity-policy-list. 
14 Contains Nonbinding Recommendations
equivalence, or if the submission is so poorly written (e.g., in broken English) that the 
information submitted to support substantial equivalence cannot be understood, the 
submission should receive an RTA decision.
Elements of a Complete Submission (RTA Items)
The objective criteria in these checklists outline those elements that are explicitly required by 
regulation or that are essential to FDAs substantive review of the submission and 
determination of substantial equivalence under section 513(i) of the FD&C Act. For example, 
proposed labels, labeling, and instructions are required by 21 CFR 807.87(e)), while a 
description of the materials, design, and other features of the device is essential to 
determining whether its technological characteristics are the same as those of the predicate 
and whether any differences raise different questions of safety and effectiveness under 
section 513(i) of the FD&C Act.
We have also identified several categories and subcategories of data and information that, 
when applicable, are critical to supporting a statement indicating the device is similar to 
and/or different from other products of comparable type under 21 CFR 807.87(f) and the 
substantial equivalence determination. For example, if the new device has direct or indirect 
tissue-contacting components, a biocompatibility assessment will be essential to evaluating 
whether the new device is as safe as the predicate with respect to the risk of toxicity it poses 
to the patient. While testing and data would usually be necessary for such an assessment, this 
is not always the case (for example if the device under review and the predicate are identical 
in all relevant respects), and acceptance should be based only on the presence of an item or 
an explanation why the item is not applicable, not the adequacy of such explanation. If the 
device has no direct or indirect tissue-contacting components, no biocompatibility 
assessment would be necessary and the biocompatibility items on the checklist would be not 
applicable.
Because the applicability of these categories is also critical to the substantial equivalence 
determination, in order to be accepted, all submissions should include a statement indicating 
whether these categories apply, as outlined in the Acceptance Checklist (e.g., materials, 
presence of software, whether the device is intended to be used sterile). When performance 
data are provided, the submission of full test reports describing how the testing was 
conducted is crucial to FDAs assessment of whether the data support a finding of substantial 
equivalence.
Where a device-specific guidance document exists for the subject device, the submitter 
should follow the recommendations included in that document, or the submitter should 
provide a rationale for addressing the scientific issues discussed in the guidance document 
using an alternative approach intended to address the applicable statutory and/or regulatory 
criteria. In the absence of the recommended information and without a rationale for an 
alternative approach, the submission should be considered incomplete and not accepted. If 
special controls have been identified, those controls should be addressed in order for the 
submission to be accepted, or alternative mitigation measures providing a rationale to 
demonstrate that those alternative measures will provide at least an equivalent assurance of 
15 Contains Nonbinding Recommendations
safety and effectiveness should be identified. 
Applying the Checklist of RTA Items
Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated, 
or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each 
question for the elements identified as RTA items. For those items that have an option of 
yes, no, or not applicable (N/A) as an answer, the item should receive an answer of 
yes or N/A for the 510(k) submission to be accepted for substantive review.
For the first question in each section related to the need for certain performance data (such as 
biocompatibility, sterilization, software), FDA staff should indicate whether the submission 
has addressed one of the options for the 510(k) submission to be accepted for substantive 
review. For example, the submission should state explicitly that either there are or are not 
direct or indirect (e.g., through fluid infusion) tissue-contacting components in order for the 
submission to be considered complete and accepted for substantive review.
Elements Marked Not applicable
In developing the checklists, the Agency has considered the general categories and respective 
subcategories of information that are necessary to conduct a substantive review for the wide 
range of medical devices that are appropriate for review under 510(k). All such criteria may 
not be pertinent to a particular device. FDA staff should select N/A for those elements that 
do not apply to the subject device. For example, the requirements for financial certification 
and disclosure statements (21 CFR 807.87(i)) and statements of compliance for clinical 
investigations (21 CFR 807.87(j)) only apply to submissions with clinical data. If the 
submission contains no clinical data, FDA staff should select N/A.
Adequacy of information
In order to make the checklist criteria objective, for each RTA item, FDA should consider 
only the presence or omission of the element or a rationale for the omission of the element or 
use of an alternative approach during acceptance review. It is likely that FDA staff will 
encounter scenarios where information is provided, but is incomplete or inadequate. In such 
instances, FDA staff should answer the question for the respective item as Yes, but may 
communicate the inadequacy or request additional information in the course of the 
substantive review. For example, the submitter may have provided full test reports for all 
performance testing; however, during the acceptance review, the reviewer may note that the 
results of a particular test may not be sufficient to support a finding of substantial 
equivalence and additional justification would be needed. The performance testing criterion 
would be marked Yes in the checklist, and the full assessment of the results and 
communication to the submitter that additional justification is needed should occur during the 
substantive review. 
During RTA review, issues may be identified that do not determine the acceptability of a 
submission, but are issues that should be resolved prior to a final decision. This does not 
16 Contains Nonbinding Recommendations
mean that a complete review of the submission has been conducted. These identified issues 
are referred to as observations. If observations are identified, they will be attached to the 
RTA checklist that is sent to the official contact. This attachment is called an Addendum. 
You do not need to provide a response to the observation(s) in your RTA response in order 
for your file to be considered administratively complete and accepted for substantive review; 
however, addressing these questions could help to facilitate the substantive review of your 
submission.
Elements Marked No
For any acceptance criterion designated as No, FDA intends to provide an explanation to 
describe the missing element(s), if needed. This explanation is particularly important for a 
criterion in which it may not be immediately apparent to the submitter what necessary 
information, specifically, is not present. For example, the Device Description section 
includes an element that states, submission addresses device description recommendations 
outlined in the device- specific guidance document and a notation of No alone may not be 
sufficient to inform the submitter of what specific piece(s) of information is missing. FDA 
staff should include a list or statement of the additional information that is necessary to meet 
the acceptance criteria. This list or statement can be communicated in the comment section 
on the checklist beside each specific criterion.
Prior Submissions Relevant to the Submission Under Review 
For certain submissions, the submitter may have made prior submissions for the same device 
for which FDA provided feedback related to the data or information needed to support 
substantial equivalence (e.g., a Q-Submission, investigational device exemption (IDE) 
application, prior NSE determination, prior 510(k) that was deleted or withdrawn). When 
such prior feedback is relevant to determining whether substantial equivalence of the subject 
device exists, the new submission should include information to address this prior feedback 
and the checklists should include criteria related to this issue.To address the criterion 
 
regarding whether a prior submission (or no prior submission) exists, FDA recommends that 
submitters provide this information in Section F (prior related submissions section) of the 
CDRH Premarket Review Submission Cover Sheet form (Form 3514).27 Submitters should 
list prior submission numbers in Section F of this form or state that there were no prior 
submissions to address this criterion. Please be advised that leaving this section of the form 
blank will not be considered a statement that there were no prior submissions. This 
information may also be included in the Cover Letter (i.e., as a statement that there were no 
prior submissions for the device or a listing of the numbers(s) of the prior submission(s)). 
Where one or more prior submissions do exist, FDA suggests designating a separate section 
of the submission that identifies the prior submission(s) by number, includes a copy of the 
FDA feedback (e.g., letter, meeting minutes), and states how or where in the submission this 
prior feedback was addressed. Note that the adequacy of how the feedback was addressed 
should be assessed during the substantive review. 
27 https://www.fda.gov/media/72421/download. 
17 Contains Nonbinding Recommendations
Combination Product Administrative Items
The 21st Century Cures Act, which amended section 503(g) of the FD&C Act, requires 
submitters seeking action on a combination product to identify the product as such (section 
503(g)(8)(C)(v) of the FD&C Act). Additionally, per the amended section 503(g)(5), 
submissions for device-led, device-drug combination products must include the patent 
certification or statement as described in section 505(b)(2) and provide notice as described in 
section 505(b)(3) if the combination product contains as a constituent part an approved drug 
(see section 503(g)(5)(A) of the FD&C Act). Submitters of products that are not combination 
products, as defined in 21 CFR 3.2(e), should mark N/A and omit this section pertaining to 
combination products.
Submitters of Combination Products That Do Not Contain as a Constituent Part an 
Approved Drug
If the combination products do not include as a constituent part an approved drug as defined 
in section 503(g)(5)(B), submitters of device-led, device-drug combination products should 
mark N/A for question 10 (question 9 in the Special RTA Checklist).
Submitters of Combination Products That Contain as a Constituent Part an Approved Drug
Submitters of combination products containing as a constituent part an approved drug should 
address question 11 (question 10 in the Special RTA Checklist) by including patent 
information. For each relevant patent, the submitter should include certification to one of the 
following certifications:
i.  That such patent information has not been filed (section 505(b)(2)(A)(i)).
ii.  That such patent has expired (section 505(b)(2)(A)(ii)).
iii.  The date on which the patent will expire (section 505(b)(2)(A)(iii)).
iv.  That such patent is invalid or will not be infringed by the manufacture, use, or sale of 
the drug constituent part for which this submission is made (section 
505(b)(2)(A)(iv)). 
However, for a method of use patent which does not claim a use for which the submitter is 
seeking approval, the submitter should include a statement per section 505(b)(2)(B) that the 
method of use patent does not claim such a use. 
Submitters including a certification under paragraph (iv) (section 505(b)(2)(A)(iv)) should 
also certify that they will provide notice to the owner of the patent(s) and the holder of the 
approved application that lists the patent(s) that is/are being challenged. The process for 
giving notice is provided in section 505(b)(3) of the FD&C Act. Submitters should submit to 
FDA documentation of the date of receipt of notice by holder of the approved application and 
patent(s) owner. 
Conversion of Special 510(k) to Traditional 510(k)
FDA has developed separate checklists to address the differences in content for Special and 
18 Contains Nonbinding Recommendations
Traditional 510(k) submissions. FDA staff will utilize the appropriate checklist based on the 
file type as designated by the submitter. In the event that the submitter has submitted a 
Special 510(k), but FDA determines that the file should be converted to a Traditional 
510(k)28 FDA will notify the contact person designated in the 510(k) submission of the 
conversion and the rationale for the conversion. If the file is converted from a Special to a 
Traditional within the 15 calendar day acceptance review period, the Traditional 510(k) 
Acceptance Checklist will be used to conduct the acceptance review and the review clock 
start date will be assigned as outlined in the 510(k) Refuse to Accept Policies and Procedures 
section above. Given the differences in content for Special and Traditional 510(k)s, it is 
likely that the converted submission will result in an RTA designation using the Traditional 
Acceptance Checklist. FDA staff should provide the completed Acceptance Checklist for 
Traditional submissions indicating which elements are missing. The submitter may respond 
by providing the identified information and the subsequent acceptance review will proceed 
with the Traditional checklist. If the file is converted from a Special to a Traditional after the 
15 calendar day acceptance review period, any missing information that would have resulted 
in RTA designation should be obtained during the substantive review. 
IX. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521).
The time required to complete this information collection is estimated to be 79.25 hours for 
preparation of a 510(k) submission. Send comments regarding this burden estimate or 
suggestions for reducing this burden to: FDA PRA Staff, Office of Operations, Food and 
Drug Administration, PRAStaff@fda.hhs.gov 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number. 
The OMB control number for this information collection is 0910-0120 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov).
28 Please see Special 510(k) Factors, items 1-4 of the Acceptance Checklist for Special 510(k)s for potential 
reasons for conversion.
19 Contains Nonbinding Recommendations
Appendix A. Acceptance Checklist for Traditional 
510(k)s 
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:  Date Received by DCC:
510(k) Lead Reviewer: 
Center: Office: Division:
Decision: Accept_____ Refuse to Accept_____
If Accept, notify the submitter.
If Refuse to Accept, notify submitter electronically and include a copy of this checklist.
Is an Addendum attached?: Yes No 
Note: If an element is left blank on the checklist, it does not mean the checklist is incomplete; 
it means the reviewer did not assess the element during the RTA review and that the element 
will be assessed during substantive review.
Preliminary Questions
Answers in the shaded blocks indicate consultation with an identified Center 
advisor is needed. (Boxes checked in this section represent FDAs preliminary 
Yes No N/A
assessment of these questions at the time of administrative review.)
1.  Is the product a device (per section 201(h) of the FD&C Act) or a 
combination product (per 21 CFR 3.2(e)) with a device constituent part 
subject to review in a 510(k)?
If it appears not to be a device (per section 201(h) of the FD&C Act) or such a 
combination product (per 21 CFR 3.2(e)), or you are unsure, consult with the 
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to 
determine the appropriate action, and inform management. Provide a summary of 
the Product Jurisdiction Officers determination/recommendation/action in the 
comment section below. 
20 Contains Nonbinding Recommendations
If the product does not appear to be a device or such a combination product, mark 
No.
Comments:
2.  Is the submission with the appropriate Center?
If the product is a device or a combination product with a device constituent part, 
is it subject to review by the Center in which the submission was received? If you 
believe the submission is not with the appropriate Center or you are unsure, 
consult with the CDRH Product Jurisdiction Officer or the CBER Product 
Jurisdiction Officer to determine the appropriate action and inform your 
management. Provide a summary of the Product Jurisdiction Officers 
determination/recommendation/action in the comment section below.
If submission should not be reviewed by your Center mark No.
Comments:
3.  If a Request for Designation (RFD) was submitted for the device or 
combination product with a device constituent part and assigned to your 
center, identify the RFD # and confirm the following:
(a)  Is the device or combination product the same (e.g., design, 
formulation) as that presented in the RFD submission?
(b)  Are the indications for use for the device or combination product 
identified in the 510(k) the same as those identified in the RFD 
submission?
If you believe the product or the indications presented in the 510(k) have changed 
from the RFD, or you are unsure, consult with the CDRH Product Jurisdiction 
Officer or the CBER Product Jurisdiction Officer to determine the appropriate 
action and inform your management. Provide a summary of Product Jurisdiction 
Officers determination/recommendation/action in the comment section below. 
If the answer to either question above is no, mark No. If there was no RFD, 
mark N/A.
Comments:
4.  Is the submission for a combination product that contains as a constituent 
part a drug that has the same active moiety as an approved drug with 
exclusivity as described in section 503(g)(5)(C)(ii)-(v) of the FD&C Act?
If Yes, then contact the CDRH Product Jurisdiction Officer or CBER Product 
Jurisdiction Officer to determine the appropriate action and inform your 
management. Provide the summary of the Product Jurisdiction Officers 
determination/recommendation/action in the comment section below.
Comments:
21 Contains Nonbinding Recommendations
5.  Is this device type eligible for a 510(k) submission? 
If a 510(k) does not appear to be appropriate (e.g., class III type and PMA 
required, or class I or II type and 510(k)-exempt), consult with the appropriate 
CDRH or CBER staff during the acceptance review, provide a summary of the 
discussion with them, and indicate their recommendation/action in the comment 
section below. If 510(k) is not the appropriate regulatory submission, mark No.
Comments:
6.  Is there a pending PMA for the same device with the same indications for 
use?
If Yes, consult your management and CDRH Office of Product Evaluation and 
Quality/Office of Regulatory Programs/Division of Regulatory Programs 1 
(Submission Support) (OPEQ/ORP/DRP1) or appropriate CBER staff to 
determine the appropriate action.
Comments:
7.  If clinical studies have been submitted, is the submitter the subject of an 
Application Integrity Policy (AIP)?
If Yes, consult with the CDRH Office of Product Evaluation and 
Quality/Office of Clinical Evidence and Analysis/Division of Clinical Science 
and Quality (OPEQ/OCEA/DCEA1) or CBER Office of Compliance and 
Biologics Quality/Division of Inspections and Surveillance/Bioresearch 
Monitoring Branch (OCBQ/DIS/BMB) to determine the appropriate action, 
provide a summary of the discussion with them, and indicate their 
recommendation/action.
If no clinical studies have been submitted, mark N/A. Check on the AIP list at 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/application-integrity-policy/application-integrity-policy-list. 
Comments:
 If the answer to 1 or 2 appears to be No, then stop review of the 510(k) and contact the 
CDRH Product Jurisdiction Officer or CBER Product Jurisdiction Officer.
 If the answer to 3a or 3b appears to be No, then stop the review and contact the CDRH 
Product Jurisdiction Officer or CBER Product Jurisdiction Officer. 
 If the answer to 4 is Yes, then contact the CDRH Product Jurisdiction Officer or CBER 
Product Jurisdiction Officer, provide a summary of the discussion with them, and indicate 
their recommendation/action.
 If the answer to 5 is No, the lead reviewer should consult division management and other 
Center resources to determine the appropriate action. Note that, for a device which is clearly 
ineligible for a 510(k) submission (such as a device type which is class III requiring PMA or 
22 Contains Nonbinding Recommendations
class I/II and 510(k) exempt), this may be considered a basis for a refusal to accept the 
submission. A 510(k) submitted for a class I/II, 510(k)-exempt device that trips the 
limitations of the exemption would not be refused on this basis.
 If the answer to 6 is Yes, then stop review of the 510(k), contact CDRH/OPEQ/ORP/DRP1, 
or appropriate CBER staff.
 If the answer to 7 is Yes, then contact CDRH/OPEQ/OCEA/DCEA1 or 
CBER/OCBQ/DIS/BMB, provide a summary of the discussion with DCEA1 or BMB Staff, 
and indicate their recommendation/action. 
Organizational Elements
Failure to include these items should not result in an RTA designation.
*Submitters including the checklist with their submission should identify the 
page numbers where requested information is located. Use the comments 
section for an element if additional space is needed to identify the location of 
supporting information.  Yes No *Page #
1. Submission contains a Table of Contents.
2. Each section is labeled (e.g., headings or tabs designating Device Description 
section, Labeling section, etc.).
3. All pages of the submission are numbered.
All pages should be numbered in such a manner that information can be 
referenced by page number. This may be done either by consecutively 
numbering the entire submission, or numbering the pages within a section 
(e.g., 12-1, 12-2...).
4. Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).
Comments:
Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed.
 Any No answer will result in a Refuse to Accept decision; however, FDA staff has discretion to 
determine whether missing items are needed to ensure that the submission is administratively 
complete to allow the submission to be accepted or to request missing checklist items interactively 
from submitters during the RTA review.
 Each element on the checklist should be addressed within the submission. The submitter may 
provide a rationale for omission for any criteria that are deemed not applicable. If a rationale is 
provided, the criterion is considered present (Yes). An assessment of the rationale will be considered 
during the review of the submission.
23 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
A. Administrative
1. All content used to support the submission is written in English 
(including translations of test reports, literature articles, etc.). 
Comments:
2. Submission identifies the following (FDA recommends use of 
the CDRH Premarket Review Submission Cover Sheet form 
(Form 3514, available at 
https://www.fda.gov/media/72421/download)):
a. Device trade/proprietary name
b. Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale 
for that conclusion
Comments:
3. Submission contains an Indications for Use Statement with Rx 
and/or OTC designated (see also 21 CFR 801.109, and FDAs 
final rule, Use of Symbols in Labeling (81 FR 38911),
available at 
https://www.federalregister.gov/documents/2016/06/15/2016-
13989/use-of-symbols-in-labeling).
See recommended format
(https://www.fda.gov/media/86323/download).
Comments:
4. Submission contains a 510(k) Summary or 510(k) Statement.
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of 
510(k) Summary and Statement, respectively. Adequacy of the 
content will be assessed during substantive review.
Comments:
24 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
5. Submission contains a Truthful and Accuracy Statement per 21 
CFR 807.87(l). 
See recommended format (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-notification-
truthful-and-accurate-statement). 
Comments:
6. Submission is a class III 510(k) Device.
Select N/A only if submission is not a class III 510(k).
a. Contains class III Summary and Certification per 21 CFR 
807.87(k).
See recommended content (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-
notification-class-iii-certification-and-summary). Select 
N/A only if submission is not a class III 510(k).
Comments:
7. Submission contains clinical data. 
Select N/A if the submission does not contain clinical data. If 
N/A is selected, parts a, b, and c below are omitted from the 
checklist.
a. Submission includes completed Financial Certification 
(FDA Form 3454, available at 
https://www.fda.gov/media/70465/download) or Disclosure 
(FDA Form 3455, available at 
https://www.fda.gov/media/69872/download) information 
for each covered clinical study included in the submission. 
Select N/A if the submitted clinical data is not a 
covered clinical study as defined in the guidance entitled 
Financial Disclosures by Clinical Investigators, 
available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/financial-
disclosure-clinical-investigators.
25 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
b. Submission includes completed Certification of 
Compliance with requirements of ClinicalTrials.gov Data 
Bank (see FDA Form 3674 which can be obtained at 
https://www.fda.gov/about-fda/reports-manuals-
forms/forms) (42 U.S.C. 282(j)(5)(B)) for each applicable 
device clinical trial included in the submission.
Select N/A if the submitted clinical data is not an 
applicable device clinical trial as defined in Title VIII of 
FDAAA, Sec. 801(j).
c. Statements of Compliance for Clinical Investigations
Select N/A if the submission does not contain any 
clinical data from investigations (as defined in 21 CFR 
812.3(h)) to demonstrate substantial equivalence.
For multicenter clinical investigations involving both 
United States (US) and outside United States (OUS) sites, 
part (i) should be addressed for the US sites and part (ii) 
should be addressed for the OUS sites. 21 CFR 812.28 
applies to all OUS clinical investigations that enroll the 
first subject on or after February 21, 2019.
Please refer to the guidance document entitled 
Acceptance of Clinical Data to Support Medical Device 
Applications and Submissions - Frequently Asked 
Questions, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/acceptance-
clinical-data-support-medical-device-applications-and-
submissions-frequently-asked for more information.
26 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
i. For each clinical investigation conducted in the US, 
the submission includes a statement that the 
investigation was conducted in compliance with 21 
CFR parts 50, 56, and 812 (or, with respect to part 56, 
that it was not subject to the regulations under 21 CFR 
56.104 or 56.105). 
OR 
The submission includes a brief statement of the 
reason for noncompliance with 21 CFR parts 50, 56, 
and/or 812.
Select N/A if the clinical investigations were 
conducted solely OUS.
ii. For each clinical investigation conducted OUS, the 
submission includes a statement that the clinical 
investigations were conducted in accordance with 
good clinical practice (GCP) as described in 21 CFR 
812.28(a)(1). 
OR
The submission includes a waiver request in 
accordance with 21 CFR 812.28(c). 
OR 
The submission includes a brief statement of the 
reason for not conducting the investigation in 
accordance with GCP and a description of steps taken 
to ensure that the data and results are credible and 
accurate and that the rights, safety, and well-being of 
subjects have been adequately protected.
Select N/A if the clinical investigations were 
conducted solely inside the US.
Comments:
27 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
8. The submission identifies prior submissions for the same device 
included in the current submission (e.g., submission numbers for 
a prior not substantially equivalent [NSE] determination, prior 
deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject 
device.
Prior submissions (or no prior submissions) for this device 
should be included in Section F (prior related submissions) of 
the CDRH Premarket Review Submission Cover Sheet form 
(Form 3514, available at 
https://www.fda.gov/media/72421/download). This information 
may also be included in the Cover Letter (i.e., as a statement that 
there were no prior submissions for the device or a listing of the 
number(s) of the prior submissions).
a. If there were prior submissions, the submitter has identified 
where in the current submission any issues related to a 
determination of substantial equivalence from prior 
submissions for this device are addressed. 
To address this criterion, it is recommended that the 
submission include a separate section with the prior 
submission number(s), a copy of the FDA feedback (e.g., 
letter, meeting minutes), and a statement of how or where 
in the submission this prior feedback was addressed. Note 
that adequacy of how the feedback was addressed will be 
assessed during the substantive review.
Select N/A if the submitter states there were no prior 
submissions.
Comments:
9. The submission utilizes voluntary consensus standard(s) (See 
section 514(c) of the FD&C Act). This includes both FDA-
recognized and non-recognized consensus standards. Select 
N/A if the submission does not utilize voluntary consensus 
standards.
a. The submission cites FDA-recognized voluntary consensus 
standard(s).
28 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
i. The submission includes a Declaration of Conformity 
(DOC) as outlined in FDAs guidance 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.
OR
If citing general use of a standard as noted in FDAs 
guidance Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical 
Devices, the basis of such use is included along with 
the underlying information or data that supports how 
the standard was used.
b. The submission cites non-FDA-recognized voluntary 
consensus standard(s).
i. The basis of use is included along with the underlying 
information or data that supports how the standard 
was used.
Comments:
Combination Product Provisions  Per 503(g) of the FD&C Act. 
Select N/A if the product is not a combination product. 21 CFR 
3.2(e). The remaining criteria in this section will be omitted from the 
checklist if "N/A" is selected. If you are unsure if the product is a 
combination product, consult with the CDRH Product Jurisdiction 
Officer or CBER Product Jurisdiction Officer.
10. Submission identifies the product as a combination product.
11. The combination product contains as a constituent part an 
approved drug as defined in section 503(g)(5)(B) of the FD&C 
Act. Select N/A if the combination product does not contain as 
a constituent part an approved drug. Please also select N/A if a 
right of reference or use for the drug constituent part(s) is 
included with the submission. If N/A is selected, part a below 
is omitted from the checklist.
29 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. The submission includes appropriate patent statement or 
certification and a statement that the submitter will give 
notice, as applicable. See section 503(g)(5)(A)&(C) of the 
FD&C Act.
Comments:
B. Device Description
12. The device has a device-specific guidance document, special 
controls, and/or requirements in a device-specific classification 
regulation regarding the device description that is applicable to 
the subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses device description 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of 
how recommendations in a device-specific guidance, etc., 
have been addressed should be assessed during the 
substantive review.
30 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
b. The submission includes device description information 
that addresses relevant mitigation measures set forth in the 
special controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
13. Descriptive information is present and consistent within the 
submission (e.g., the device description section is consistent with 
the device description in the labeling).
Comments:
14. The submission includes descriptive information for the device, 
including the following:
a. A description of the principle of operation or mechanism of 
action for achieving the intended effect.
b. A description of proposed conditions of use, such as 
surgical technique for implants; anatomical location of use; 
user interface; how the device interacts with other devices; 
and/or how the device interacts with the patient.
c. A list and description of each device for which clearance is 
requested.
Select N/A if there is only one device or model. 
Device may refer to models, part numbers, various sizes, 
etc.
31 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
d. Submission contains representative engineering drawing(s), 
schematics, illustrations, photos and/or figures of the 
device.
OR
Submission includes a statement that engineering drawings, 
schematics, etc. are not applicable to the device (e.g., 
device is a reagent and figures are not pertinent to describe 
the device).
In lieu of engineering drawings, schematics, etc. of each 
device to be marketed, representative drawings, etc. may 
be provided, where representative is intended to mean 
that the drawings, etc. provided capture the differences in 
design, size, and other important characteristics of the 
various models, sizes, or versions of the device(s) to be 
marketed.
Comments:
15. Device is intended to be marketed with accessories and/or as part 
of a system.
Select N/A if the device is not intended to be marketed with 
accessories and/or as part of a system. If N/A is selected, 
parts a-c below are omitted from the checklist.
a. Submission includes a list of all accessories to be marketed 
with the subject device.
b. Submission includes a description (as detailed in item 
14a., 14b., and 14d. above) of each accessory.
Select N/A if the accessory(ies) has been previously 
cleared, or is exempt, and the proposed indications for use 
are consistent with the cleared indications.
c. A 510(k) number is provided for each accessory that 
received a prior 510(k) clearance.
AND
A statement is provided that identifies accessories that have 
not received prior 510(k) clearance.
Comments:
32 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
C. Substantial Equivalence Discussion
16. Submitter has identified a predicate device(s), including the 
following information:
a. Predicate device identifier provided (e.g., 510(k) number, 
De Novo number, reclassified PMA number, classification 
regulation reference, if exempt (e.g., 21 CFR 872.3710), or 
statement that the predicate is a preamendment device).
For predicates that are preamendments devices, 
information is provided to document preamendments 
status.
Information regarding documenting preamendment status 
is available online (https://www.fda.gov/medical-
devices/quality-and-compliance-medical-
devices/preamendment-status).
b. The identified predicate(s) is consistent throughout the 
submission (e.g., the predicate(s) identified in the 
Substantial Equivalence section is the same as that listed in 
the 510(k) Summary (if applicable) and that used in 
comparative performance testing.
 
Comments:
17. Submission includes a comparison of the following for the 
predicate(s) and subject device and a discussion why any 
differences between the subject and predicate(s) do not impact 
safety and effectiveness [see section 513(i)(1)(A) of the FD&C 
Act and 21 CFR 807.87(f)].
See the FDA guidance document 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 
for more information on comparing intended use and 
technological characteristics.
33 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. Indications for use
If there are no differences between the subject device and 
the predicate(s) with respect to indications and intended 
use, this should be explicitly stated.
b. Technology, including technical specifications, features, 
materials, and principles of operation
Examples of technological characteristics include, but are 
not limited to design, features, materials, energy source, 
and principle of operation.
FDA recommends a tabular format for comparing 
technological characteristics. Any characteristic that is the 
same as the predicate(s) should be explicitly stated. 
Differences in technological characteristics should be 
identified and a rationale provided why they do not raise 
different questions of safety and effectiveness.
Comments:
D. Proposed Labeling (see also 21 CFR parts 801 and 809 as 
applicable)
18. Submission includes proposed package labels and labeling (e.g., 
instructions for use, package insert, operators manual).
a. Indications for use are stated in labeling and are identical to 
Indications for Use form and 510(k) Summary (if 510(k) 
Summary provided).
b. Labeling includes:
-  Statements of conditions, purposes or uses for which 
the device is intended (e.g., hazards, warnings, 
precautions, contraindications) (21 CFR 801.5) 
AND
-  Includes adequate directions for use (see 21 CFR 
801.5) 
OR
-  Submission states that device qualifies for exemption 
per 21 CFR 801 Subpart D
34 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Comments:
19. Labeling includes name and place of business of the 
manufacturer, packer, or distributor (21 CFR 801.1).
Comments:
20. Labeling includes the prescription statement (see 21 CFR 
801.109(b)(1)) or Rx Only symbol (see also Section 502(a) of 
the FD&C Act and FDAs final rule, Use of Symbols in 
Labeling (81 FR 38911), available at 
https://www.federalregister.gov/documents/2016/06/15/2016-
13989/use-of-symbols-in-labeling).
Select N/A if not indicated for prescription use.
Comments:
21. The device has a device-specific guidance document, special 
controls, and/or requirements in a device-specific classification 
regulation regarding labeling that is applicable to the subject 
device. 
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses labeling recommendations 
outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of 
how recommendations in a device-specific guidance, etc., 
have been addressed should be assessed during the 
substantive review.
35 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
b. The submission includes labeling information that 
addresses relevant mitigation measures set forth in the 
special controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
22. If the device is an in vitro diagnostic device, provided labeling 
includes all applicable information required per 21 CFR 809.10.
Select N/A if not an in vitro diagnostic device.
Comment:
E. Sterilization
If an in vitro diagnostic (IVD) device and sterilization is not applicable, 
select N/A. The criteria in this section will be omitted from the 
checklist if N/A is selected.
36 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Submission states that the device and/or accessories, if applicable, are: (one of 
the below must be checked) 
Provided sterile, intended to be single-use 
Requires processing during its use-life
Non-sterile when used (and no processing required) 
Information regarding the sterility status of the device is not provided (if this 
box is checked, please also check one of the two boxes below) 
Sterility status not needed for this device (e.g., software-only device)
Sterility status needed or need unclear 
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If non-sterile when used or not provided and not needed is selected, the 
sterility-related criteria below are omitted from the checklist. 
If information on sterility status is not provided, and it is needed or the need for 
this information is unclear, select No.
The Requires processing during its use-life option refers to devices falling 
into one of the four categories below:
 Supplied sterile and requires reprocessing prior to subsequent patient 
use
 Supplied non-sterile and requires user to process the device for initial 
use, as well as to reprocess the device after each use
 Reusable medical device (single-user) reprocessed between each use
 Single-use medical devices initially supplied as non-sterile to the user, 
and requiring the user to process the device prior to its use
Please refer to the FDA guidance document Reprocessing Medical Devices in 
Health Care Settings: Validation Methods and Labeling, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/reprocessing-medical-devices-health-care-settings-validation-
methods-and-labeling, for additional information.
Comments:
23. Assessment of the need for cleaning and subsequent disinfection 
or sterilization information.
37 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. Identification of device and/or accessories, if applicable, 
that are provided sterile.
Select N/A if no part of the device or accessories are 
provided sterile.
b. Identification of device and/or accessories, if applicable, 
that are end user sterilized or disinfected.
Select N/A if no part of the device are accessories are 
end user sterilized or disinfected.
c. Identification of device and/or accessories, if applicable, 
that are reusable.
Select N/A if no part of the device or accessories, are 
reusable.
Comments:
24. If the device and/or accessories, if applicable, are provided 
sterile:
Select N/A if no part of the device or accessories are provided 
sterile, otherwise complete a-f below.
a. Sterilization method is stated for each device (including 
dose for radiation sterilization)
b. A description of method to validate the sterilization 
parameters is provided for each proposed sterilization 
method (e.g., half-cycle method and full citation of FDA-
recognized standard, including date). 
Note: the sterilization validation report is not required.
c. For devices sterilized using chemical sterilants such as 
ethylene oxide (EO) and hydrogen peroxide, submission 
states maximum levels of sterilant residuals remaining on 
the device and sterilant residual limits.
Select N/A if not sterilized using chemical sterilants.
d. Sterility Assurance Level (SAL) stated
e. Submission includes description of packaging
38 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
f. For products labeled non-pyrogenic, a description of the 
method used to make the determination stated (e.g., limulus 
amebocyte lysate [LAL]). 
Select N/A if not labeled non-pyrogenic.
Comments: 
25. If the device and/or accessory, if applicable, is reusable or end 
user sterilized or disinfected: 
Select N/A if no part of the device or accessories are reusable 
or end user sterilized or disinfected, otherwise complete a-d 
below.
a. Cleaning method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not reusable and does not need cleaning 
prior to disinfection or sterilization.
b. Disinfection method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not disinfected (i.e., undergoes terminal 
sterilization) prior to use.
c. Sterilization method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not sterilized (i.e., undergoes disinfection) 
prior to use.
39 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
d. Device types in this submission are listed in the Federal 
Register (FR) Notice entitled Validated Instructions for 
Use and Validation Data Requirements for Certain 
Reusable Medical Devices in Premarket Notifications 
(Reprocessing FR Notice, available at 
https://www.federalregister.gov/documents/2017/06/09/201
7-12007/medical-devices-validated-instructions-for-use-
and-validation-data-requirements-for-certain-reusable).
Device types identified in the Reprocessing FR Notice 
represent devices posing a greater likelihood of microbial 
transmission and represent a high risk of infection. Select 
N/A if the device type in the submission is not included in 
the Reprocessing FR Notice.
i. If device types in this submission are 
included in the Reprocessing FR Notice, the 
submission includes protocols and test 
reports for validating the reprocessing 
instructions.
Select N/A if the device type in the 
submission is not included in the 
Reprocessing FR Notice.
Comments:
26. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding sterility and/or reprocessing that is 
applicable to the subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
40 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. The submission addresses sterility and/or reprocessing 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
b. The submission includes sterility and/or reprocessing 
information that addresses relevant mitigation measures set 
forth in the special controls or device-specific classification 
regulation applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
F. Shelf-Life
27. Proposed shelf life/ expiration date stated
OR
Statement that shelf-life is not applicable because of low 
likelihood of time-dependent product degradation.
41 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Comments:
28. For a sterile device, submission includes summary of methods 
used to establish that device packaging will maintain a sterile 
barrier for the entirety of the proposed shelf-life. 
Select N/A if the device is not provided sterile.
Comments:
29. Submission includes summary of methods used to establish that 
device performance is maintained for the entirety of the proposed 
shelf-life (e.g., mechanical properties, coating integrity, pH, 
osmolality, etc.).
OR
Statement why performance data is not needed to establish 
maintenance of device performance characteristics over the 
shelf-life period.
Comments:
G. Biocompatibility
If an in vitro diagnostic (IVD) device, select N/A. The criteria in this 
section will be omitted from the checklist if N/A is selected.
42 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Submission states that there: (one of the below must be checked) 
Are direct or indirect tissue-contacting components
Are no direct or indirect tissue-contacting components 
Information regarding tissue contact status of the device is not provided (if 
this box checked, please also check one of the two boxes below) 
Tissue contact information not needed for this device (e.g., software-
only device)
Tissue contact information is needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If are no or not provided and not needed is selected, the biocompatibility-
related criteria below are omitted from the checklist. If information on the 
tissue-contact status is not provided, and contact information is needed or its 
contact status is unclear, select No.
An example of a direct tissue-contacting device would be an implant that has 
direct contact with tissues during use. An example of an indirect tissue-
contacting device would be fluid entering the body following passing through 
device/device components not in direct contact with the tissue.
Comments:
30. Submission includes a list identifying each tissue-contacting 
device component (e.g., implant, delivery catheter) and 
associated materials of construction for each component, 
including identification of color additives, if present.
Comments:
31. Submission identifies contact classification (e.g., surface-
contacting, less than 24 hour duration) for each tissue-contacting 
device component (e.g., implant, delivery catheter).
Comments:
43 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
32. For a biocompatibility assessment of tissue-contacting 
components, submission includes:
 Each relevant endpoint for the device (as identified in device-
specific guidance, or Attachment A of the FDA guidance 
document entitled Use of International Standard ISO 10993-
1, Biological evaluation of medical devices - Part 1: 
Evaluation and testing within a risk management process, 
available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/use-
international-standard-iso-10993-1-biological-evaluation-
medical-devices-part-1-evaluation-and), has been addressed.
 For any testing performed, test protocol (including 
identification and description of test article including whether 
the test article is the device in its final finished form using the 
recommended approach in Attachment F of Use of 
International Standard ISO 10993-1, Biological evaluation 
of medical devices - Part 1: Evaluation and testing within a 
risk management process, methods, and pass/fail criteria), 
and analysis of results (including tables with data points and 
statistical analyses, where appropriate), as described in 
Attachment E of the guidance document entitled Use of 
International Standard ISO 10993-1, Biological evaluation 
of medical devices - Part 1: Evaluation and testing within a 
risk management process provided for each completed test.  
OR 
A statement that biocompatibility testing is not needed with a 
rationale that considers all relevant endpoints (e.g., materials and 
manufacturing/processing are identical to the predicate).
Comments:
H. Software
44 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Submission states that the device: (one of the below must be checked) 
Does contain software/firmware 
Does not contain software/firmware 
Information on whether device contains software/firmware is not provided 
(if this box checked, please also check one of the two boxes below) 
Software/firmware information not needed for this device (e.g., surgical 
suture, condom)
Software/firmware information is needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not contain or not provided and not needed is selected, the 
software-related criteria below are omitted from the checklist. If information 
on software is not provided, and this information is needed or the need is 
unclear, select No.
Comments:
33. Submission includes a statement of software level of concern and 
rationale for the software level of concern
Comments:
34. All applicable software documentation provided based on level 
of concern identified by the submitter, as described in Guidance 
for the Content of Premarket Submissions for Software 
Contained in Medical Devices, available at 
https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-content-premarket-submissions-
software-contained-medical-devices, or the submission includes 
information to establish that the submitter has otherwise met the 
applicable statutory or regulatory criteria through an alternative 
approach (i.e., the submitter has identified an alternate approach 
with a rationale). 
Note: This element is also applicable to non-internally generated 
or off-the-shelf (OTS) software used in the device.
45 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Comments:
I. Cybersecurity
Submission states that the device: (one of the below must be checked) 
Does contain any external wired and/or wireless communication interfaces 
(Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, 
inductive, Cloud, etc.)
Does not contain external interfaces as described above 
Information on whether device has external interfaces is not provided (if this 
box is checked, please also check one of the two boxes below)
Cybersecurity information not needed for this device (e.g., surgical 
suture, condom)
Cybersecurity information is needed or need unclear 
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not contain or not provided and not needed is selected, the 
cybersecurity criteria below are omitted from the checklist. If information on 
cybersecurity is not provided, and this information is needed or the need is 
unclear, select No.
35. All applicable documentation identified by the submitter, as 
described in Guidance for the Content of Premarket 
Submissions for Management of Cybersecurity in Medical 
Devices, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/content-premarket-
submissions-management-cybersecurity-medical-devices-0. 
OR
Submission includes information to establish that the submitter 
has otherwise met the applicable statutory or regulatory criteria 
through an alternative approach (i.e., the submitter has identified 
an alternate approach with a rationale).
Comments:
J.  Electrical Safety and EMC
46 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Electrical Safety:
Submission states that the device: (one of the below must be checked) 
Does require electrical safety evaluation 
Does not require electrical safety evaluation 
Information on whether device requires electrical safety evaluation is not 
provided (if this box checked, please also check one of the two boxes below) 
Electrical safety information not needed for this device (e.g., surgical 
suture, condom)
Electrical safety information needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not require or not provided and not needed is selected, the 
electrical safety criteria below are omitted from the checklist. If information on 
electrical safety is not provided, and it is needed or the need for this 
information is unclear, select No.
36. Submission includes evaluation of electrical safety (e.g., per IEC 
60601-1, or equivalent FDA-recognized standard, and if 
applicable, a device-specific standard). 
OR 
Submission includes electrical safety evaluation using methods or 
standards that are not FDA-recognized and submission includes 
information to establish that the submitter has otherwise met the 
applicable statutory or regulatory criteria through this alternative 
approach (i.e., the submitter has identified alternate methods or 
standards with a rationale).
Comments:
47 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
EMC:
Submission states that the device: (one of the below must be checked) 
Does require EMC evaluation 
Does not require EMC evaluation 
Information on whether device requires EMC evaluation not provided (if this 
box checked, please also check one of the two boxes below)
EMC information not needed for this device (e.g., surgical suture, 
condom)
EMC information needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not require or not provided and not needed is selected, the EMC 
criteria below are omitted from the checklist. If information on EMC is not 
provided, and it is needed or the need for this information is unclear, select 
No.
Comments:
37. Submission includes evaluation of electromagnetic 
compatibility (e.g., per IEC 60601-1-2 or equivalent FDA-
recognized standard and if applicable, a device-specific 
standard).
OR
Submission includes electromagnetic compatibility evaluation 
using methods or standards that are not FDA-recognized and 
submission includes information to establish that the submitter 
has otherwise met the applicable statutory or regulatory criteria 
through this alternative approach (i.e., the submitter has 
identified alternate methods or standards with a rationale).
Comments:
48 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
K. Performance Data General
If an in vitro diagnostic (IVD) device, select N/A. The criteria in this 
section will be omitted from the checklist if N/A is selected. 
Performance data criteria relating to IVD devices is addressed in 
Section L.
Comments:
38. Summaries of the non-clinical laboratory studies and full test 
reports* are provided.
*Summary and full test report content recommendations can be 
found in FDAs guidance Recommended Content and Format 
of Non-Clinical Bench Performance Testing Information in 
Premarket Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/recommended-content-and-format-non-
clinical-bench-performance-testing-information-premarket. 
If a submitter chooses to declare conformity to a voluntary 
consensus standard that FDA has recognized, submission of a 
full test report may not be necessary. Refer to 9a. See FDAs 
guidance 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.
Select N/A if the submission appropriately does not include 
performance data or there are no completed tests without a 
Declaration of Conformity.
a. Submission includes an explanation of how the data 
generated from each test supports a finding of substantial 
equivalence (e.g., comparison to predicate device testing, 
dimensional analysis, etc.).
Select N/A if the submission does not include 
performance data.
Comments:
49 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
39. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding performance data that is applicable to the 
subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses performance data 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of 
how recommendations in a device-specific guidance, etc., 
have been addressed should be assessed during the 
substantive review.
b. The submission includes performance data that addresses 
relevant mitigation measures set forth in the special 
controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific regulation. Select No if the submission 
does not include a rationale for any omitted information or 
any alternative approach as outlined above. Note that the 
adequacy of how such mitigation measures have been 
addressed should be assessed during the substantive 
review.
Comments:
50 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
40. If literature is referenced in the submission, submission 
includes:
Select N/A if the submission does not reference literature. If 
N/A is selected, parts a and b below are omitted from the 
checklist.
Note that the applicability of the referenced article to support a 
substantial equivalence finding should be assessed during the 
substantive review; only the presence of a discussion is required 
to support acceptance.
a. Legible reprints or a summary of each article.
b. Discussion of how each article is applicable to support the 
substantial equivalence of the subject device to the 
predicate.
Comments:
41. For each completed animal study, the submission provides the 
following:
Select N/A if no animal study was conducted. If N/A is 
selected, parts a-c below are omitted from the checklist. Note 
that this section does not address biocompatibility evaluations, 
which are assessed in Section G of the checklist.
a. Submission includes a study protocol which includes all 
elements as outlined in 21 CFR 58.120
b. Submission includes final study report which includes all 
elements outlined in 21 CFR 58.185
c. Submission contains a statement that the study was 
conducted in compliance with applicable requirements in 
the GLP regulation (21 CFR Part 58), OR, if the study was 
not conducted in compliance with the GLP regulation, the 
submission explains why the noncompliance would not 
impact the validity of the study data provided to support a 
substantial equivalence determination.
Comments:
51 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
L. Performance Characteristics  In Vitro Diagnostic Devices Only 
(see also 21 CFR 809.10(b)(12))
Submission indicates that device: (one of the below must be checked) 
Is an in vitro diagnostic device
Is not an in vitro diagnostic device
If is not is selected, the performance data-related criteria below are 
omitted from the checklist.
42. Submission includes the following studies, as appropriate for the 
device type, including associated protocol descriptions, study 
results and line data:
a. Precision/reproducibility
b. Accuracy (includes as appropriate linearity; calibrator or 
assay traceability; calibrator and/or assay stability protocol 
and acceptance criteria; assay cut-off; method comparison 
or comparison to clinical outcome; matrix comparison; and 
clinical reference range or cutoff).
c. Sensitivity (detection limits, LoB, LoD, LoQ where 
relevant for the device type).
d. Analytical specificity
Comments:
43. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding performance data that is applicable to the 
subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
52 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information is located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. The submission addresses performance data 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of 
how recommendations in a device-specific guidance, etc., 
have been addressed should be assessed during the 
substantive review.
b. The submission includes performance data that addresses 
relevant mitigation measures set forth in the special 
controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
53 Contains Nonbinding Recommendations
Digital Signature Concurrence Table
Reviewer Sign-Off
Management Sign-Off
(digital signature 
optional)*
*Management review of checklist and concurrence with decision required. 
54 Contains Nonbinding Recommendations
Appendix B. Acceptance Checklist for Abbreviated 
510(k)s 
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:  Date Received by DCC:
510(k) Lead Reviewer: 
Center: Office: Division:
Decision: Accept_____ Refuse to Accept_____
If Accept, notify the submitter
If Refuse to Accept, notify submitter electronically and include a copy of this checklist.
Is an Addendum attached?: Yes No 
Note: If an element is left blank on the checklist, it does not mean the checklist is incomplete; 
it means the reviewer did not assess the element during the RTA review and that the element 
will be assessed during substantive review.
Preliminary Questions
Answers in the shaded blocks indicate consultation with an identified Center 
advisor is needed. (Boxes checked in this section represent FDAs preliminary 
Yes No N/A
assessment of these questions at the time of administrative review.)
1.  Is the product a device (per section 201(h) of the FD&C Act) or a combination 
product (per 21 CFR 3.2(e)) with a device constituent part subject to review in 
a 510(k)?
If it appears not to be a device (per section 201(h) of the FD&C Act) or such a 
combination product (per 21 CFR 3.2(e)), or you are unsure, consult with the 
CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction Officer to 
determine the appropriate action, and inform management. Provide a summary of 
the Product Jurisdiction Officers determination/recommendation/action in the 
comment section below. 
If the product does not appear to be a device or such a combination product, mark 
55 Contains Nonbinding Recommendations
No.
Comments:
2.  Is the submission with the appropriate Center?
If the product is a device or a combination product with a device constituent part, is 
it subject to review by the Center in which the submission was received? If you 
believe the submission is not with the appropriate Center or you are unsure, consult 
with the CDRH Product Jurisdiction or the CBER Product Jurisdiction Officer to 
determine the appropriate action and inform your management. Provide a summary 
of the Product Jurisdiction Officers determination/recommendation/action in the 
comment section below. 
If submission should not be reviewed by your Center mark No.
Comments:
3.  If a Request for Designation (RFD) was submitted for the device or 
combination product with a device constituent part and assigned to your 
center, identify the RFD # and confirm the following:
(a) Is the device or combination product the same (e.g., design, 
formulation) as that presented in the RFD submission?
(b) Are the indications for use for the device or combination product 
identified in the 510(k) the same as those identified in the RFD 
submission?
If you believe the product or the indications presented in the 510(k) have changed 
from the RFD, or you are unsure, consult with the CDRH Product Jurisdiction 
Officer or the CBER Product Jurisdiction Officer to determine the appropriate 
action and inform your management. Provide summary of Product Jurisdiction 
Officers determination/recommendation/action in the comment section below.
If the answer to either question above is no, mark No. If there was no RFD, mark 
N/A.
Comments:
4.  Is the submission for a combination product that contains as a constituent 
part a drug that has the same active moiety as an approved drug with 
exclusivity as described in section 503(g)(5)(C)(ii)-(v) of the FD&C Act?
If Yes, then contact the CDRH Product Jurisdiction Officer or CBER Product 
Jurisdiction Officer to determine the appropriate action and inform your 
management. Provide the summary of the Product Jurisdiction Officers 
determination/recommendation/action in the comment section below. 
56 Contains Nonbinding Recommendations
Comments:
5.  Is this device type eligible for a 510(k) submission? 
If a 510(k) does not appear to be appropriate (e.g., class III type and PMA required, 
or class I or II type and 510(k)-exempt), consult with the appropriate CDRH or 
CBER staff during the acceptance review, provide a summary of the discussion 
with them, and indicate their recommendation/action in the comment section 
below. If 510(k) is not the appropriate regulatory submission, mark No.
Comments:
6.  Is there a pending PMA for the same device with the same indications for use?
If Yes, consult your management and CDRH Office of Product Evaluation and 
Quality/Office of Regulatory Programs/Division of Regulatory Programs 1 
(Submission Support) (OPEQ/ORP/DRP1) or appropriate CBER staff to determine 
the appropriate action.
Comments:
7.  If clinical studies have been submitted, is the submitter the subject of an 
Application Integrity Policy (AIP)?
If Yes, consult with the CDRH Office of Product Evaluation and Quality/Office 
of Clinical Evidence and Analysis/Division of Clinical Science and Quality 
(OPEQ/OCEA/DCEA1) or CBER Office of Compliance and Biologics 
Quality/Division of Inspections and Surveillance/Bioresearch Monitoring Branch 
(OCBQ/DIS/BMB) to determine the appropriate action, provide a summary of the 
discussion with them, and indicate their recommendation/action. 
If no clinical studies have been submitted, mark N/A. Check on the AIP list at 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/application-integrity-policy/application-integrity-policy-list. 
Comments:
 If the answer to 1 or 2 appears to be No, then stop review of the 510(k) and 
contact the CDRH Product Jurisdiction Officer or CBER Product Jurisdiction 
Officer.
 If the answer to 3a or 3b appears to be No, then stop the review and contact 
the CDRH Product Jurisdiction Officer or CBER Product Jurisdiction Officer. 
 If the answer to 4 is Yes, then contact the CDRH Product Jurisdiction Officer 
or CBER Product Jurisdiction Officer, provide a summary of the discussion with 
them, and indicate their recommendation/action.
 If the answer to 5 is No, the lead reviewer should consult division management 
and other Center resources to determine the appropriate action. Note that, for a 
device which is clearly ineligible for a 510(k) submission (such as a device type 
which is class III requiring PMA or class I/II and 510(k) exempt), this may be 
57 Contains Nonbinding Recommendations
considered a basis for a refusal to accept the submission. A 510(k) submitted for 
a class I/II, 510(k)-exempt device that trips the limitations of the exemption 
would not be refused on this basis.
 If the answer to 6 is Yes, then stop review of the 510(k), contact 
CDRH/OPEQ/ORP/DRP1, or appropriate CBER staff.
 If the answer to 7 is Yes, then contact CDRH/OPEQ/OCEA/DCEA1 or 
CBER/OCBQ/DIS/BMB, provide a summary of the discussion with DCEA1 or 
BMB Staff, and indicate their recommendation/action. 
Abbreviated 510(k) Criteria
(See The Abbreviated 510(k) Program, available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/abbreviated-510k-program and 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)
 
In order to qualify for review as an Abbreviated 510(k), one of the following criteria (1 or 2 or 3) should be 
met. Submission should be converted and reviewed as a Traditional 510(k) if one of these criteria is not 
met. Complete the Refuse to Accept Checklist for a Traditional 510(k) if submission is converted.
Yes No N/A
1.  Submission relies on a guidance document and a summary report is provided 
that:
Select N/A if submission does not rely on any guidance document(s). If Yes, 
address parts a and b below.
a. Includes the device description, the manufacturers device design 
requirements, risk management information, and a description of test 
methods used to address performance characteristics.
b. Includes a description of how the guidance document was used to satisfy the 
requirements of 21 CFR 807.87 (e.g., data to support substantial 
equivalence) and lists any deviations, that is any alternative methods used to 
demonstrate substantial equivalence that is not described in the guidance.
Select No if the sponsor does not address whether there were deviations.
Comments:
2.  Submission relies on special control(s) to demonstrate substantial equivalence 
and a summary report is provided that:
Select N/A if submission does not rely on any special controls. If Yes, address 
parts a-d below.
58 Contains Nonbinding Recommendations
a. Includes the device description, the manufacturers device design 
requirements, risk management information, and a description of test 
methods used to address performance characteristics.
b. Includes a description of how the special control(s) was satisfied. 
Comments:
3.  Submission relies on voluntary consensus standard(s) (See section 514(c) of the 
FD&C Act). This includes both FDA-recognized and non-recognized consensus 
standards.
Select N/A if submission does not rely on any voluntary consensus standard(s). If 
Yes, address part a below.
a. The submission cites FDA-recognized voluntary consensus standard(s).
i. The submission includes a Declaration of Conformity (DOC) as 
outlined in FDAs guidance 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.
OR
If citing general use of a standard as noted in FDAs guidance 
Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices, the basis of such use is included 
along with the underlying information or data that supports how the 
standard was used.
b. The submission cites non-FDA-recognized voluntary consensus 
standard(s).
i. The basis of use is included along with the underlying information or 
data that supports how the standard was used.
Comments:
Does the submission meet one of the criteria above?
Yes, submission meets criteria for an Abbreviated 510(k). Continue with the 
remainder of this checklist below.
No, submission does not meet criteria for an Abbreviated 510(k). Discontinue this 
RTA checklist, convert to a Traditional and apply the Traditional checklist.
59 Contains Nonbinding Recommendations
Organizational Elements
Failure to include these items should not result in an RTA designation.
*Submitters including the checklist with their submission should identify the 
page numbers where requested information is located. Use the comments 
section for an element if additional space is needed to identify the location of 
supporting information.  Yes No *Page #
1. Submission contains a Table of Contents.
2. Each section is labeled (e.g., headings or tabs designating Device Description 
section, Labeling section, etc.).
3. All pages of the submission are numbered.
All pages should be numbered in such a manner that information can be 
referenced by page number. This may be done either by consecutively 
numbering the entire submission, or numbering the pages within a section 
(e.g., 12-1, 12-2...).
4. Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).
Comments:
Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed
 Any No answer will result in a Refuse to Accept decision; however, FDA staff has discretion to 
determine whether missing items are needed to ensure that the submission is administratively 
complete to allow the submission to be accepted or to request missing checklist items interactively 
from submitters during the RTA review.
 Each element on the checklist should be addressed within the submission. The submitter may 
provide a rationale for omission for any criteria that are deemed not applicable. If a rationale is 
provided, the criterion is considered present (Yes). An assessment of the rationale will be considered 
during the review of the submission.
60 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
A. Administrative
1. All content used to support the submission is written in English 
(including translations of test reports, literature articles, etc.). 
Comments:
2. Submission identifies the following (FDA recommends use of 
the CDRH Premarket Review Submission Cover Sheet form 
(Form 3514, available at 
https://www.fda.gov/media/72421/download)):
a. Device trade/proprietary name
b. Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale 
for that conclusion
Comments:
3. Submission contains an Indications for Use Statement with Rx 
and/or OTC designated (see also 21 CFR 801.109, and FDAs 
final rule, Use of Symbols in Labeling (81 FR 38911), 
available at 
https://www.federalregister.gov/documents/2016/06/15/2016-
13989/use-of-symbols-in-labeling). 
See recommended format 
(https://www.fda.gov/media/86323/download).
Comments:
4. Submission contains a 510(k) Summary or 510(k) Statement.
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of 
510(k) Summary and Statement, respectively. Adequacy of the 
content will be assessed during substantive review.
Comments:
61 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
5. Submission contains a Truthful and Accuracy Statement per 21 
CFR 807.87(l). 
See recommended format (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-notification-
truthful-and-accurate-statement). 
Comments:
6. Submission is a class III 510(k) Device.
Select N/A only if submission is not a class III 510(k).
a. Contains Class III Summary and Certification per 21 CFR 
807.87(k).
See recommended content (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-
notification-class-iii-certification-and-summary). Select 
N/A only if submission is not a Class III 510(k).
Comments:
7. Submission contains clinical data. 
Select N/A if the submission does not contain clinical data. If 
N/A is selected, parts a, b, and c below are omitted from the 
checklist.
a. Submission includes completed Financial Certification 
(FDA Form 3454, available at 
https://www.fda.gov/media/70465/download) or Disclosure 
(FDA Form 3455, available at 
https://www.fda.gov/media/69872/download) information 
for each covered clinical study included in the submission. 
Select N/A if the submitted clinical data is not a 
covered clinical study as defined in the guidance entitled 
Financial Disclosures by Clinical Investigators, 
available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/financial-
disclosure-clinical-investigators.
62 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
b. Submission includes completed Certification of 
Compliance with requirements of ClinicalTrials.gov Data 
Bank (see FDA Form 3674 which can be obtained at 
https://www.fda.gov/about-fda/reports-manuals-
forms/forms) (42 U.S.C. 282(j)(5)(B)) for each applicable 
device clinical trial included in the submission.
Select N/A if the submitted clinical data is not an 
applicable device clinical trial as defined in Title VIII of 
FDAAA, Sec. 801(j) 
c. Statements of Compliance for Clinical Investigations
Select N/A if the submission does not contain any 
clinical data from investigations (as defined in 21 CFR 
812.3(h)) to demonstrate substantial equivalence.
For multicenter clinical investigations involving both 
United States (US) and outside United States (OUS) sites, 
part (i) should be addressed for the US sites and part (ii) 
should be addressed for the OUS sites. 21 CFR 812.28 
applies to all OUS clinical investigations that enroll the 
first subject on or after February 21, 2019.
Please refer to the guidance document entitled Acceptance 
of Clinical Data to Support Medical Device Applications 
and Submissions - Frequently Asked Questions, available 
at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/acceptance-clinical-data-support-
medical-device-applications-and-submissions-frequently-
asked, for more information.
63 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
i. For each clinical investigation conducted in the US, the 
submission includes a statement that the investigation 
was conducted in compliance with 21 CFR parts 50, 
56, and 812 (or, with respect to part 56, that it was not 
subject to the regulations under 21 CFR 56.104 or 
56.105). 
OR 
The submission includes a brief statement of the 
reason for noncompliance with 21 CFR parts 50,56 
and/or 812.
Select N/A if the clinical investigations were 
conducted solely OUS.
ii. For each clinical investigation conducted OUS, the 
submission includes a statement that the clinical 
investigations were conducted in accordance with good 
clinical practice (GCP) as described in 21 CFR 
812.28(a)(1). 
OR
The submission includes a waiver request in 
accordance with 21 CFR 812.28(c). 
OR 
The submission includes a brief statement of the 
reason for not conducting the investigation in 
accordance with GCP and a description of steps taken 
to ensure that the data and results are credible and 
accurate and that the rights, safety, and well-being of 
subjects have been adequately protected.
Select N/A if the clinical investigations were 
conducted solely inside the US.
Comments:
64 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
8. The submission identifies prior submissions for the same device 
included in the current submission (e.g., submission numbers for 
a prior not substantially equivalent [NSE] determination, prior 
deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject 
device.
Prior submissions (or no prior submissions) for this device 
should be included in Section F (prior related submissions) of 
the CDRH Premarket Review Submission Cover Sheet form 
(Form 3514, available at 
https://www.fda.gov/media/72421/download). This information 
may also be included in the Cover Letter (i.e., as a statement 
that there were no prior submissions for the device or a listing 
of the number(s) of the prior submissions).
a. If there were prior submissions, the submitter has identified 
where in the current submission any issues related to a 
determination of substantial equivalence from prior 
submissions for this device are addressed. 
To address this criterion, it is recommended that the 
submission include a separate section with the prior 
submission number(s), a copy of the FDA feedback (e.g., 
letter, meeting minutes), and a statement of how or where in 
the submission this prior feedback was addressed. Note that 
adequacy of how the feedback was addressed will be 
assessed during the substantive review.
Select N/A if the submitter states there were no prior 
submissions.
Comments:
Combination Product Provisions  Per 503(g) of the FD&C Act. 
Select N/A if the product is not a combination product. 21 CFR 
3.2(e). The remaining criteria in this section will be omitted from the 
checklist if "N/A" is selected. If you are unsure if the product is a 
combination product, consult with the CDRH Product Jurisdiction 
Officer or CBER Product Jurisdiction Officer.
65 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
9. Submission identifies the product as a combination product.
10. The combination product contains as a constituent part an 
approved drug as defined in section 503(g)(5)(B) of the FD&C 
Act. Select N/A if the combination product does not contain 
as a constituent part an approved drug. Please also select N/A 
if a right of reference or use for the drug constituent part(s) is 
included with the submission. If N/A is selected, part a below 
is omitted from the checklist.
a. The submission includes appropriate patent statement or 
certification and a statement that the submitter will give 
notice, as applicable. See section 503(g)(5)(A)&(C) of the 
FD&C Act.
Comments:
B. Device Description
11. The device has a device-specific guidance document, special 
controls, and/or requirements in a device-specific classification 
regulation regarding the device description that is applicable to 
the subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses device description 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
66 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
b. The submission includes device description information 
that addresses relevant mitigation measures set forth in the 
special controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
12. Descriptive information is present and consistent within the 
submission (e.g., the device description section is consistent 
with the device description in the labeling).
Comments:
13. The submission includes descriptive information for the device, 
including the following:
a. A description of the principle of operation or mechanism of 
action for achieving the intended effect.
b. A description of proposed conditions of use, such as 
surgical technique for implants; anatomical location of use; 
user interface; how the device interacts with other devices; 
and/or how the device interacts with the patient.
c. A list and description of each device for which clearance is 
requested.
Select N/A if there is only one device or model. Device 
may refer to models, part numbers, various sizes, etc.
67 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
d. Submission contains representative engineering drawing(s), 
schematics, illustrations, photos and/or figures of the 
device.
OR
Submission includes a statement that engineering drawings, 
schematics, etc. are not applicable to the device (e.g., 
device is a reagent and figures are not pertinent to describe 
the device).
In lieu of engineering drawings, schematics, etc. of each 
device to be marketed, representative drawings, etc. may 
be provided, where representative is intended to mean 
that the drawings, etc. provided capture the differences in 
design, size, and other important characteristics of the 
various models, sizes, or versions of the device(s) to be 
marketed.
Comments:
14. Device is intended to be marketed with accessories and/or as 
part of a system.
Select N/A if the device is not intended to be marketed with 
accessories, and/or as part of a system. If N/A is selected, 
parts a-c below are omitted from the checklist.
a. Submission includes a list of all accessories to be marketed 
with the subject device.
b. Submission includes a description (as detailed in item 
13a., 13b., and 13d. above) of each accessory.
Select N/A if the accessory(ies) has been previously 
cleared, or is exempt, and the proposed indications for use 
are consistent with the cleared indications.
c. A 510(k) number is provided for each accessory that 
received a prior 510(k) clearance
AND
A statement is provided that identifies accessories that have 
not received prior 510(k) clearance.
Comments:
68 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
C. Substantial Equivalence Discussion
15. Submitter has identified a predicate device(s), including the 
following information:
a. Predicate device identifier provided (e.g., 510(k) number, 
De Novo number, reclassified PMA number, classification 
regulation reference, if exempt (e.g., 21 CFR 872.3710), or 
statement that the predicate is a preamendment device).
For predicates that are preamendments devices, information 
is provided to document preamendments status.
Information regarding documenting preamendment status 
is available online (https://www.fda.gov/medical-
devices/quality-and-compliance-medical-
devices/preamendment-status).
b. The identified predicate(s) is consistent throughout the 
submission (e.g., the predicate(s) identified in the 
Substantial Equivalence section is the same as that listed in 
the 510(k) Summary (if applicable) and that used in 
comparative performance testing.
 
Comments:
16. Submission includes a comparison of the following for the 
predicate(s) and subject device and a discussion why any 
differences between the subject and predicate(s) do not impact 
safety and effectiveness [see section 513(i)(1)(A) of the FD&C 
Act and 21 CFR 807.87(f)].
See The 510(k) Program: Evaluating Substantial Equivalence 
in Premarket Notifications [510(k)] guidance document, 
available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k for more information 
on comparing intended use and technological characteristics.
a. Indications for use
If there are no differences between the subject device and 
the predicate(s) with respect to indications and intended 
use, this should be explicitly stated.
69 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
b. Technology, including technical specifications, features, 
materials, and principles of operation
Examples of technological characteristics include, but are 
not limited to design, features, materials, energy source, 
and principle of operation.
FDA recommends a tabular format for comparing 
technological characteristics. Any characteristic that is the 
same as the predicate(s) should be explicitly stated. 
Differences in technological characteristics should be 
identified and a rationale provided why they do not raise 
different questions of safety and effectiveness.
Comments:
D. Proposed Labeling (see also 21 CFR parts 801 and 809 as 
applicable)
17. Submission includes proposed package labels and labeling (e.g., 
instructions for use, package insert, operators manual).
a. Indications for use are stated in labeling and are identical to 
Indications for Use form and 510(k) Summary (if 510(k) 
Summary provided).
b. Labeling includes:
-  Statements of conditions, purposes or uses for which 
the device is intended (e.g., hazards, warnings, 
precautions, contraindications) (21 CFR 801.5) 
AND
-  Includes adequate directions for use (see 21 CFR 
801.5) 
OR
-  Submission states that device qualifies for exemption 
per 21 CFR 801 Subpart D
Comments:
18. Labeling includes name and place of business of the 
manufacturer, packer, or distributor (21 CFR 801.1).
70 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Comments:
19. Labeling includes the prescription statement (see 21 CFR 
801.109(b)(1)) or Rx Only symbol (see also Section 502(a) of 
the FD&C Act and FDAs final rule, Use of Symbols in 
Labeling (81 FR 38911), available at 
https://www.federalregister.gov/documents/2016/06/15/2016-
13989/use-of-symbols-in-labeling).
Select N/A if not indicated for prescription use.
Comments:
20. The device has a device-specific guidance document, special 
controls, and/or requirements in a device-specific classification 
regulation regarding labeling that is applicable to the subject 
device. 
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses labeling recommendations 
outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
71 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
b. The submission includes labeling information that 
addresses relevant mitigation measures set forth in the 
special controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
21. If the device is an in vitro diagnostic device, provided labeling 
includes all applicable information required per 21 CFR 809.10.
Select N/A if not an in vitro diagnostic device.
Comment:
E. Sterilization
If an in vitro diagnostic (IVD) device and sterilization is not 
applicable, select N/A. The criteria in this section will be omitted 
from the checklist if N/A is selected.
72 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Submission states that the device and/or accessories, if applicable, are: (one of 
the below must be checked) 
Provided sterile, intended to be single-use 
Requires processing during its use-life
Non-sterile when used (and no processing required) 
Information regarding the sterility status of the device is not provided (if 
this box is checked, please also check one of the two boxes below) 
Sterility status not needed for this device (e.g., software-only device)
Sterility status needed or need unclear 
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If non-sterile when used or not provided and not needed is selected, the 
sterility-related criteria below are omitted from the checklist. 
If information on sterility status is not provided, and it is needed or the need 
for this information is unclear, select No.
The Requires processing during its use-life option refers to devices falling 
into one of the four categories below:
 Supplied sterile and requires reprocessing prior to subsequent patient 
use
 Supplied non-sterile and requires user to process the device for initial 
use, as well as to reprocess the device after each use
 Reusable medical device (single-user) reprocessed between each use
 Single-use medical devices initially supplied as non-sterile to the user, 
and requiring the user to process the device prior to its use
Please refer to the guidance document titled Reprocessing Medical Devices 
in Health Care Settings: Validation Methods and Labeling, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/reprocessing-medical-devices-health-care-settings-validation-
methods-and-labeling, for additional information.
Comments:
22. Assessment of the need for cleaning and subsequent disinfection 
or sterilization information.
73 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
a. Identification of device and/or accessories, if applicable, 
that are provided sterile.
Select N/A if no part of the device or accessories are 
provided sterile.
b. Identification of device and/or accessories, if applicable, 
that are end user sterilized or disinfected.
Select N/A if no part of the device or accessories are end 
user sterilized or disinfected.
c. Identification of device and/or accessories, if applicable, 
that are reusable.
Select N/A if no part of the device or accessories are 
reusable.
Comments:
23. If the device and/or accessories, if applicable, are provided 
sterile:
Select N/A if no part of the device or accessories are provided 
sterile, otherwise complete a-f below.
a. Sterilization method is stated for each device (including 
dose for radiation sterilization)
b. A description of method to validate the sterilization 
parameters is provided for each proposed sterilization 
method (e.g., half-cycle method and full citation of FDA-
recognized standard, including date). 
Note: the sterilization validation report is not required.
c. For devices sterilized using chemical sterilants such as 
ethylene oxide (EO) and hydrogen peroxide, submission 
states maximum levels of sterilant residuals remaining on 
the device and sterilant residual limits.
Select N/A if not sterilized using chemical sterilants.
d. Sterility Assurance Level (SAL) stated
e. Submission includes description of packaging
74 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
f. For products labeled non-pyrogenic, a description of the 
method used to make the determination stated (e.g., limulus 
amebocyte lysate [LAL]). 
Select N/A if not labeled non-pyrogenic.
Comments: 
24. If the device and/or accessory, if applicable, is reusable or end 
user sterilized or disinfected: 
Select N/A if no part of the device or accessories are reusable 
or end user sterilized or disinfected, otherwise complete a-d 
below.
a. Cleaning method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not reusable and does not need cleaning 
prior to disinfection or sterilization.
b. Disinfection method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not disinfected (i.e., undergoes terminal 
sterilization) prior to use.
c. Sterilization method is provided in labeling for each device 
and/or accessory, if applicable. 
Select N/A if not sterilized (i.e., undergoes disinfection) 
prior to use.
75 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
d. Device types in this submission are listed in the Federal 
Register Notice entitled Validated Instructions for Use and 
Validation Data Requirements for Certain Reusable 
Medical Devices in Premarket Notifications (Reprocessing 
FR Notice, available at 
https://www.federalregister.gov/documents/2017/06/09/201
7-12007/medical-devices-validated-instructions-for-use-
and-validation-data-requirements-for-certain-reusable).
Device types identified in the Reprocessing FR Notice 
devices posing a greater likelihood of microbial 
transmission and represent a high risk of infection. Select 
N/A if the device type in the submission is not included in 
the Reprocessing FR Notice.
i. If device types in this submission are included in the 
Reprocessing FR Notice, the submission includes 
protocols and test reports for validating the 
reprocessing instructions.
Select N/A if the device type in the submission is not 
included in the Reprocessing FR Notice.
Comments:
25. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding sterility and/or reprocessing that is 
applicable to the subject device
If N/A is selected, parts a and b below are omitted from the 
checklist.
76 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
a. The submission addresses sterility and/or reprocessing 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
b. The submission includes sterility and/or reprocessing 
information that addresses relevant mitigation measures set 
forth in the special controls or device-specific classification 
regulation applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
F. Shelf-Life
26. Proposed shelf-life/expiration date stated
OR
Statement that shelf-life is not applicable because of low 
likelihood of time-dependent product degradation
77 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Comments:
27. For a sterile device, submission includes summary of methods 
used to establish that device packaging will maintain a sterile 
barrier for the entirety of the proposed shelf-life. 
Select N/A if the device is not provided sterile.
Comments:
28. Submission includes summary of methods used to establish that 
device performance is maintained for the entirety of the 
proposed shelf-life (e.g., mechanical properties, coating 
integrity, pH, osmolality, etc.).
OR
Statement why performance data is not needed to establish 
maintenance of device performance characteristics over the 
shelf-life period.
Comments:
G. Biocompatibility
If an in vitro diagnostic (IVD) device, select N/A. The criteria in this 
section will be omitted from the checklist if N/A is selected.
78 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Submission states that there: (one of the below must be checked) 
Are direct or indirect tissue-contacting components
Are no direct or indirect tissue-contacting components 
Information regarding tissue contact status of the device is not provided (if 
this box checked, please also check one of the two boxes below) 
Tissue contact information not needed for this device (e.g., software-
only device)
Tissue contact information is needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If are no or not provided and not needed is selected, the 
biocompatibility-related criteria below are omitted from the checklist. If 
information on the tissue-contact status is not provided, and contact 
information is needed or its contact status is unclear, select No.
An example of a direct tissue-contacting device would be an implant that has 
direct contact with tissues during use. An example of an indirect tissue-
contacting device would be fluid entering the body following passing through 
device/device components not in direct contact with the tissue.
Comments:
29. Submission includes a list identifying each tissue-contacting 
device component (e.g., implant, delivery catheter) and 
associated materials of construction for each component, 
including identification of color additives, if present.
Comments:
30. Submission identifies contact classification (e.g., surface-
contacting, less than 24 hour duration) for each tissue-contacting 
device component (e.g., implant, delivery catheter).
Comments:
79 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
31. For a biocompatibility assessment of tissue-contacting 
components, submission includes:
 Each relevant endpoint for the device (as identified in 
device-specific guidance, or Attachment A of the FDA 
guidance document entitled Use of International Standard 
ISO 10993-1, Biological evaluation of medical devices - 
Part 1: Evaluation and testing within a risk management 
process, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/use-
international-standard-iso-10993-1-biological-evaluation-
medical-devices-part-1-evaluation-and), has been addressed.
 For any testing performed, test protocol (including 
identification and description of test article including 
whether the test article is the device in its final finished form 
using the recommended approach in Attachment F of Use 
of International Standard ISO 10993-1, Biological 
evaluation of medical devices - Part 1: Evaluation and 
testing within a risk management process, methods, and 
pass/fail criteria), and analysis of results (including tables 
with data points and statistical analyses, where appropriate), 
as described in Attachment E of the guidance document 
entitled Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices - Part 1: 
Evaluation and testing within a risk management process 
provided for each completed test. 
OR 
A statement that biocompatibility testing is not needed with a 
rationale that considers all relevant endpoints (e.g., materials and 
manufacturing/processing are identical to the predicate).
Comments:
H. Software
80 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Submission states that the device: (one of the below must be checked) 
Does contain software/firmware 
Does not contain software/firmware 
Information on whether device contains software/firmware is not provided 
(if this box checked, please also check one of the two boxes below) 
Software/firmware information not needed for this device (e.g., 
surgical suture, condom)
Software/firmware information is needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not contain or not provided and not needed is selected, the 
software-related criteria below are omitted from the checklist. If information 
on software is not provided, and this information is needed or the need is 
unclear, select No.
Comments:
32. Submission includes a statement of software level of concern 
and rationale for the software level of concern.
Comments:
33. All applicable software documentation provided based on level 
of concern identified by the submitter, as described in Guidance 
for the Content of Premarket Submissions for Software 
Contained in Medical Devices, available at 
https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-content-premarket-submissions-
software-contained-medical-devices, or the submission includes 
information to establish that the submitter has otherwise met the 
applicable statutory or regulatory criteria through an alternative 
approach (i.e., the submitter has identified an alternate approach 
with a rationale). 
Note: This element is also applicable to non-internally 
generated or off-the-shelf (OTS) software used in the device.
81 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Comments:
I. Cybersecurity
Submission states that the device: (one of the below must be checked) 
Does contain any external wired and/or wireless communication interfaces 
(Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, 
inductive, Cloud, etc.)
Does not contain external interfaces as described above 
Information on whether device has external interfaces in not provided (if 
this box is checked, please also check one of the two boxes below) 
Cybersecurity information not needed for this device (e.g., surgical 
suture, condom)
Cybersecurity information is needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not contain or not provided and not needed is selected, the 
cybersecurity criteria below are omitted from the checklist. If information on 
cybersecurity is not provided, and this information is needed or the need is 
unclear, select No.
34. All applicable documentation identified by the submitter, as 
described in Guidance for the Content of Premarket 
Submissions for Management of Cybersecurity in Medical 
Devices, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/content-premarket-
submissions-management-cybersecurity-medical-devices-0. 
OR
Submission includes information to establish that the submitter 
has otherwise met the applicable statutory or regulatory criteria 
through an alternative approach (i.e., the submitter has identified 
an alternate approach with a rationale).
Comments:
J. Electrical Safety and EMC
82 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Electrical Safety:
Submission states that the device: (one of the below must be checked) 
Does require electrical safety evaluation 
Does not require electrical safety evaluation 
Information on whether device requires electrical safety evaluation not 
provided (if this box checked, please also check one of the two boxes 
below) 
Electrical safety information not needed for this device (e.g., surgical 
suture, condom)
Electrical safety information needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not require or not provided and not needed is selected, the 
electrical safety criteria below are omitted from the checklist. If information 
on electrical safety is not provided, and it is needed or the need for this 
information is unclear, select No.
Comments:
35. Submission includes evaluation of electrical safety (e.g., per IEC 
60601-1, or equivalent FDA-recognized standard, and if 
applicable, a device-specific standard). 
OR 
Submission includes electrical safety evaluation using methods 
or standards that are not FDA-recognized and submission 
includes information to establish that the submitter has 
otherwise met the applicable statutory or regulatory criteria 
through this alternative approach (i.e., the submitter has 
identified alternate methods or standards with a rationale).
Comments:
83 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
EMC:
Submission states that the device: (one of the below must be checked) 
Does require EMC evaluation 
Does not require EMC evaluation 
Information on whether device requires EMC evaluation not provided (if 
this box checked, please also check one of the two boxes below)
EMC information not needed for this device (e.g., surgical suture, 
condom)
EMC information needed or need unclear
This information will determine whether and what type of additional 
information may be necessary for a substantial equivalence determination.
If does not require or not provided and not needed is selected, the EMC 
criteria below are omitted from the checklist. If information on EMC is not 
provided, and it is needed or the need for this information is unclear, select 
No.
Comments:
36. Submission includes evaluation of electromagnetic 
compatibility (e.g., per IEC 60601-1-2 or equivalent FDA-
recognized standard and if applicable, a device-specific 
standard).
OR
Submission includes electromagnetic compatibility evaluation 
using methods or standards that are not FDA-recognized and 
submission includes information to establish that the submitter 
has otherwise met the applicable statutory or regulatory criteria 
through this alternative approach (i.e., the submitter has 
identified alternate methods or standards with a rationale). 
Comments:
84 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
K. Performance Data General
If an in vitro diagnostic (IVD) device, select N/A. The criteria in this 
section will be omitted from the checklist if N/A is selected. 
Performance data criteria relating to IVD devices is addressed in 
Section L.
Comments:
37. Summaries of the non-clinical laboratory studies and full test 
reports* are provided.
*Summary and full test report content recommendations can 
be found in FDAs guidance Recommended Content and 
Format of Non-Clinical Bench Performance Testing 
Information in Premarket Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/recommended-content-and-format-non-
clinical-bench-performance-testing-information-premarket. 
If a submitter chooses to declare conformity to a voluntary 
consensus standard that FDA has recognized, submission of a 
full test report may not be necessary. Refer to Abbreviated 
Criteria #3. See FDAs guidance 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.
Select N/A if the submission appropriately does not include 
performance data or there are no completed tests without a 
Declaration of Conformity.
a. Submission includes an explanation of how the data 
generated from each test supports a finding of substantial 
equivalence (e.g., comparison to predicate device testing, 
dimensional analysis, etc.).
Select N/A if the submission does not include 
performance data.
85 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Comments:
38. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding performance data that is applicable to the 
subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses performance data 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
b. The submission includes performance data that addresses 
relevant mitigation measures set forth in the special 
controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
86 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
Comments:
39. If literature is referenced in the submission, submission 
includes:
Select N/A if the submission does not reference literature. If 
N/A is selected, parts a and b below are omitted from the 
checklist.
Note that the applicability of the referenced article to support a 
substantial equivalence finding should be assessed during the 
substantive review; only the presence of a discussion is required 
to support acceptance.
a. Legible reprints or a summary of each article.
b. Discussion of how each article is applicable to support the 
substantial equivalence of the subject device to the 
predicate.
Comments:
40. For each completed animal study, the submission provides the 
following:
Select N/A if no animal study was conducted. If N/A is 
selected, parts a-c below are omitted from the checklist. Note 
that this section does not address biocompatibility evaluations, 
which are assessed in Section G of the checklist.
a. Submission includes a study protocol which includes all 
elements as outlined in 21 CFR 58.120
b. Submission includes final study report which includes all 
elements outlined in 21 CFR 58.185
c. Submission contains a statement that the study was 
conducted in compliance with applicable requirements in 
the GLP regulation (21 CFR Part 58), OR, if the study was 
not conducted in compliance with the GLP regulation, the 
submission explains why the noncompliance would not 
impact the validity of the study data provided to support a 
substantial equivalence determination.
Comments:
87 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
L. Performance Characteristics  In Vitro Diagnostic Devices Only 
(see also 21 CFR 809.10(b)(12))
Submission indicates that device: (one of the below must be checked) 
Is an in vitro diagnostic device
Is not an in vitro diagnostic device
If is not is selected, the performance data-related criteria below are 
omitted from the checklist.
41. Submission includes the following studies, as appropriate for the 
device type, including associated protocol descriptions, study 
results and line data:
a. Precision/reproducibility
b. Accuracy (includes as appropriate linearity; calibrator or 
assay traceability; calibrator and/or assay stability protocol 
and acceptance criteria; assay cut-off; method comparison 
or comparison to clinical outcome; matrix comparison; and 
clinical reference range or cutoff).
c. Sensitivity (detection limits, LoB, LoD, LoQ where 
relevant for the device type).
d. Analytical specificity
Comments:
42. The device has a device-specific guidance document, special 
controls, and/or requirement in a device-specific classification 
regulation regarding performance data that is applicable to the 
subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
88 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should 
identify the page numbers where requested information is located. Use 
the comments section for an element if additional space is needed to 
identify the location of supporting information. Yes No N/A *Page #
a. The submission addresses performance data 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended 
to address the applicable statutory and/or regulatory 
criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review.
b. The submission includes performance data that addresses 
relevant mitigation measures set forth in the special 
controls or device-specific classification regulation 
applicable to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted 
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures 
have been addressed should be assessed during the 
substantive review.
Comments:
Digital Signature Concurrence Table
Reviewer Sign-Off
89 Contains Nonbinding Recommendations
Management Sign-Off
(digital signature 
optional)*
*Management review of checklist and concurrence with decision required. 
90 Contains Nonbinding Recommendations
Appendix C. Acceptance Checklist for Special 510(k)s 
(Should be completed within 15 days of DCC receipt)
The following information is not intended to serve as a comprehensive review.
FDA recommends that the submitter include this completed checklist as part of the application.
510(k)#:  Date Received by DCC:
510(k) Lead Reviewer: 
Center: Office: Division:
Decision: Accept_____ Refuse to Accept_____
If Accept, notify the submitter.
If Refuse to Accept, notify submitter electronically and include a copy of this checklist.
Is an Addendum attached?: Yes No 
Note: If an element is left blank on the checklist, it does not mean the checklist is incomplete; 
it means the reviewer did not assess the element during the RTA review and that the element 
will be assessed during substantive review.
Special 510(k) Factors
(See The Special 510(k) Program, available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/special-510k-program)
Please complete the below questions to determine if the 510(k) is appropriate for review as a Special 
510(k). Complete the Refuse to Accept Checklist for a Traditional 510(k) if submission is converted.
Yes No
1. 510(k) is submitted to modify a legally marketed device (predicate) AND 
the Special 510(k) submission is submitted by the manufacturer legally 
authorized to market the predicate device.
Comments:
2. Performance data are needed to evaluate the change. If a manufacturer 
determines under their design control procedures that no additional 
verification or validation testing is necessary to evaluate a change, 
manufacturers may submit these changes as a Special 510(k) with a clear 
rationale supporting their conclusion that no performance data are necessary. 
When FDA does not agree with the manufacturer's assessment, FDA intends to
91 Contains Nonbinding Recommendations
continue with the additional Special 510(k) factors.
Comments:
3. There is a well-established method to evaluate the change. Well-established 
methods include those used in the previously cleared 510(k), an FDA-
recognized consensus standard or FDA guidance document, qualified medical 
device development tools (MDDTs), are widely available and accepted, or 
found acceptable through a different premarket submission by the same 
manufacturer of the predicate.
Comments:
4. The data be reviewed in a summary or risk analysis format. The results 
from verification and validation associated with design or labeling changes 
should be able to be placed in a summary or risk analysis format without losing 
information necessary to support SE. Complete test reports should not be 
submitted in a Special 510(k). If complete test reports are submitted, FDA 
intends to assess whether the information can be reviewed in a summary format 
before converting to a Traditional 510(k).
Comments:
Is the submission appropriate for review as a Special 510(k)? Answer Yes if the change 
was submitted by the manufacturer of the predicate, well-established methods are available 
for any performance data necessary, and performance data can be reviewed in a summary or 
risk analysis format.
Yes, submission is appropriate for a Special 510(k). Continue checklist below.
No, submission is not appropriate for a Special 510(k). Discontinue this RTA checklist, 
convert to a Traditional and apply the Traditional checklist.
Organizational Elements
Failure to include these items should not result in an RTA designation.
*Submitters including the checklist with their submission should identify the 
page numbers where requested information located. Use the comments 
section for an element if additional space is needed to identify the location of 
supporting information. Yes No *Page #
1. Submission contains a Table of Contents.
2. Each section is labeled (e.g., headings or tabs designating Device Description 
section, Labeling section, etc.).
3. All pages of the submission are numbered.
All pages should be numbered in such a manner that information can be 
referenced by page number. This may be done either by consecutively 
numbering the entire submission, or numbering the pages within a section 
92 Contains Nonbinding Recommendations
(e.g., 12-1, 12-2...).
4. Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).
Comments:
Elements of a Complete Submission (RTA Items)
(21 CFR 807.87 unless otherwise indicated)
Submission should be designated RTA if not addressed
 Any No answer will result in a Refuse to Accept decision; however, FDA staff has discretion to 
determine whether missing items are needed to ensure that the submission is administratively 
complete to allow the submission to be accepted or to request missing checklist items interactively 
from submitters during the RTA review.
 Each element on the checklist should be addressed within the submission. The submitter may 
provide a rationale for omission for any criteria that are deemed not applicable. If a rationale is 
provided, the criterion is considered present (Yes). An assessment of the rationale will be considered 
during the review of the submission.
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
A. Administrative
1. All content used to support the submission is written in English 
(including translations of test reports, literature articles, etc.). 
Comments:
2. Submission identifies the following (FDA recommends use of the 
CDRH Premarket Review Submission Cover Sheet form (Form 
3514, available at https://www.fda.gov/media/72421/download)):
a. Device trade/proprietary name
b. Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale for 
that conclusion
Comments:
3. Submission contains an Indications for Use Statement with Rx 
93 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed.  
 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
and/or OTC designated (see also 21 CFR 801.109, and FDAs final 
rule, Use of Symbols in Labeling (81 FR 38911), available at 
https://www.federalregister.gov/documents/2016/06/15/2016-
13989/use-of-symbols-in-labeling). 
See recommended format 
(https://www.fda.gov/media/86323/download). 
    Comments: 
  4.  Submission contains a 510(k) Summary or 510(k) Statement. 
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of 510(k) 
Summary and Statement, respectively. Adequacy of the content will 
be assessed during substantive review.
Comments:
5. Submission contains a Truthful and Accuracy Statement per 21 
CFR 807.87(l).
See recommended format (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-notification-
truthful-and-accurate-statement). 
Comments:
6. Submission is a Class III 510(k) Device.
Select N/A only if submission is not a Class III 510(k).
a. Contains Class III Summary and Certificationper 21 CFR 
807.87(k).
See recommended content (https://www.fda.gov/medical-
devices/premarket-notification-510k/premarket-notification-
class-iii-certification-and-summary). Select N/A only if 
submission is not a Class III 510(k).
Comments
7. The submission identifies prior submissions for the same device 
included in the current submission (e.g., submission numbers for a 
prior not substantially equivalent [NSE] determination, prior 
deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject device.
94 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed.  
 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Prior submissions (or no prior submissions) for this device should 
be included in Section F (prior related submissions) of the CDRH 
Premarket Review Submission Cover Sheet form (Form 3514, 
available at https://www.fda.gov/media/72421/download). This 
information may also be included in the Cover Letter (i.e., as a 
statement that there were no prior submissions for the device or a 
listing of the number(s) of the prior submissions). 
a. If there were prior submissions, the submitter has identified 
where in the current submission any issues related to a 
determination of substantial equivalence from prior 
submissions for this device are addressed. 
To address this criterion, it is recommended that the 
submission include a separate section with the prior 
submission number(s), a copy of the FDA feedback (e.g., letter, 
meeting minutes), and a statement of how or where in the 
submission this prior feedback was addressed. Note that 
adequacy of how the feedback was addressed will be assessed 
during the substantive review.
Select N/A if the submitter states there were no prior 
submissions.
Comments:
8. The submission utilizes voluntary consensus standard(s) (See 
section 514(c) of the FD&C Act). This includes both FDA-
recognized and non-recognized consensus standards. Select N/A 
if the submission does not utilize voluntary consensus standards.
a. The submission cites FDA-recognized voluntary consensus 
standard(s).
95 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
i. The submission includes a Declaration of Conformity 
(DOC) as outlined in FDAs guidance 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. 
OR
If citing general use of a standard as noted in FDAs 
guidance Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical 
Devices,the basis of such use is included along with 
the underlying information or data that supports how 
the standard was used. 
b. The submission cites non-FDA-recognized voluntary 
consensus standard(s).
i. The basis of use is included along with the underlying 
information or data that supports how the standard was 
used.
Comments:
Combination Product Provisions  Per 503(g) of the FD&C Act. 
Select N/A if the product is not a combination product. 21 CFR 3.2(e). 
The remaining criteria in this section will be omitted from the checklist if 
"N/A" is selected. If you are unsure if the product is a combination 
product, consult with the CDRH Product Jurisdiction Officer or CBER 
Product Jurisdiction Officer.
9. Submission identifies the product as a combination product.
10. The combination product contains as a constituent part an 
approved drug as defined in section 503(g)(5)(B) of the FD&C 
Act. Select N/A if the combination product does not contain as a 
constituent part an approved drug. Please also select N/A if a 
right of reference or use for the drug constituent part(s) is included 
with the submission. If N/A is selected, part a below is omitted 
from the checklist.
96 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
a. The submission includes appropriate patent statement or 
certification and a statement that the submitter will give 
notice, as applicable. See section 503(g)(5)(A)&(C) of the 
FD&C Act.
Comments:
B. Device Description
11. The device has a device-specific guidance document, special 
controls, and/or requirements in a device-specific classification 
regulation regarding the device description that is applicable to the 
subject device.
If N/A is selected, parts a and b below are omitted from the 
checklist.
a. The submission addresses device description 
recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended to 
address the applicable statutory and/or regulatory criteria.
Select N/A if there is no applicable device-specific 
guidance. Select No if the submission does not include a 
rationale for any omitted information or any alternative 
approach as outlined above. Note that the adequacy of how 
recommendations in a device-specific guidance, etc., have 
been addressed should be assessed during the substantive 
review. 
b. The submission includes device description information that 
addresses relevant mitigation measures set forth in the special 
controls or device-specific classification regulation applicable 
to the device.
OR
The submission uses alternative mitigation measures and 
provides rationale why the alternative measures provide an 
equivalent assurance of safety and effectiveness.
Select N/A if there are no applicable special controls or 
device-specific classification regulation. Select No if the 
submission does not include a rationale for any omitted
97 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed.  
 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
information or any alternative approach as outlined above. 
Note that the adequacy of how such mitigation measures have 
been addressed should be assessed during the substantive 
review.  
    Comments: 
  12.  Descriptive information is present and consistent within the         
submission (e.g., the device description section is consistent with 
the device description in the labeling). 
    Comments: 
  13.  The submission includes descriptive information for the device, 
including the following:
a. A description of the principle of operation ormechanism of 
action for achieving the intended effect.
b. A description of proposed conditions of use, such as surgical 
technique for implants; anatomical location of use; user 
interface; how the device interacts with other devices; and/or 
how the device interacts with the patient.
c. A list and description of each device for which clearance is 
requested.
Select N/A if there is only one device or model. Device 
may refer to models, part numbers, various sizes, etc.
d. Submission contains representative engineering drawing(s), 
schematics, illustrations, photos and/or figures of the device.
OR
Submission includes a statement that engineering drawings, 
schematics, etc. are not applicable to the device (e.g., device is 
a reagent and figures are not pertinent to describe the device).
In lieu of engineering drawings, schematics, etc. of each 
device to be marketed, representative drawings, etc. may be 
provided, where representative is intended to mean that the 
drawings, etc. provided capture the differences in design, size, 
and other important characteristics of the various models, 
sizes, or versions of the device(s) to be marketed.
98 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
Comments:
14. A detailed description of all device modification(s) including 
rationale for each modification. 
When labeling or specific technological characteristics (e.g., 
materials, dimensions) are unchanged in comparison to the 
predicate, the submission should clearly state that no changes were 
made.
Comments:
15. Device is intended to be marketed with accessories and/or as part 
of a system.
Select N/A if the device is not intended to be marketed with 
accessories and/or as part of a system. If N/A is selected, parts 
a-c below are omitted from the checklist.
a. Submission includes a list of all accessories to be marketed 
with the subject device.
b. Submission includes a description (as detailed in item 
13a., 13b., and 13d. above) of each accessory.
Select N/A if the accessory(ies) has been previously 
cleared, or is exempt, and the proposed indications for use are 
consistent with the cleared indications.
c. A 510(k) number is provided for each accessory that received 
a prior 510(k) clearance
AND
A statement is provided that identifies accessories that have 
not received prior 510(k) clearance.
Comments:
C. Substantial Equivalence Discussion
16. Submitter has identified a predicate device(s), including the 
following information:
a. Predicate device identifier provided (e.g., 510(k) number, De 
Novo number, reclassified PMA number, classification 
regulation reference, if exempt (e.g., 21 CFR 872.3710), or 
99 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed.  
 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
statement that the predicate is a preamendment device).
For predicates that are preamendments devices, information is 
provided to document preamendments status. 
Information regarding documenting preamendment status is 
available online (https://www.fda.gov/medical-
devices/quality-and-compliance-medical-
devices/preamendment-status).
b. The identified predicate(s) is consistent throughout the 
submission (e.g., the predicate(s) identified in the Substantial 
Equivalence section is the same as that listed in the 510(k) 
Summary (if applicable) and that used in comparative 
performance testing.
Comments:
17. Submission includes a comparison of the following for the 
predicate(s) and subject device and a discussion why any 
differences between the subject and predicate(s) do not impact 
safety and effectiveness [see section 513(i)(1)(A) of the FD&C Act 
and 21 CFR 807.87(f)]
See the FDA guidance document 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 
for more information on comparing intended use and technological 
characteristics.
a. Indications for use
If there are no differences between the subject device and the 
predicate(s) with respect to indications and intended use, this 
should be explicitly stated.
b. Technology, including technical specifications, features, 
materials, and principles of operation
Examples of technological characteristics include, but are not 
limited to design, features, materials, energy source, and 
principle of operation.
100 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed. 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
FDA recommends a tabular format for comparing 
technological characteristics. Any characteristic that is the 
same as the predicate(s) should be explicitly stated. 
Differences in technological characteristics should be 
identified and a rationale provided why they do not raise 
different questions of safety and effectiveness.
D. Design Control Activities
18. Design Control Activities Summary includes all of the following:
a. Identification of risk analysis method(s) used to assess the 
impact of the modification on the device AND the results of 
the analysis.
b. Identification of the device change(s).
c.  Identification of all risks associated with each device change, 
including identification of risks that are considered new 
because of the change; and
d.  Risk control measures to mitigate identified risks (e.g., 
labeling, verification).
e. Based on the Risk Analysis, an identification of the 
verification and/or validation activities required to comply 
with 21 CFR 820.30. This identification includes a summary 
of test methods (including any protocol deviations), 
acceptance criteria, results in a summary or risk analysis 
format (e.g., basic descriptive statistics, where appropriate), 
and why each is adequate to establish substantial equivalence. 
If unchanged from a previous premarket submission, the 
manufacturer references the location of protocols and 
acceptance criteria by providing a submission and section 
numbers.
i. For non-standardized test methods only:
  A reference to the protocol used for the existing 
device with an identification of any differences 
(e.g., protocol, test conditions, pre-defined 
acceptance criteria, sample size) from the 
previous 510(k). If protocol changes were 
101 Contains Nonbinding Recommendations
Check Yes if item is present, N/A if it is not needed and No if it is 
not included but needed.  
 
*Submitters including the checklist with their submission should identify 
the page numbers where requested information located. Use the 
comments section for an element if additional space is needed to identify 
the location of supporting information. Yes No N/A *Page #
made, the results summary describes why the 
test methods, acceptance criteria, and results 
support SE.
f. A signed statement by the manufacturers designated 
individual(s) responsible for design control activities. Both 
items below must be present to answer Yes.
i.  Statement that, as required by the risk analysis, all 
verification and validation activities were performed by 
designated individual(s) and the results demonstrated 
that the predetermined acceptance criteria were met.
ii. Statement that the submitter has complied and is not 
currently in violation of the design control procedure 
requirements as specified in 21 CFR 820.30 and the 
records are available for review, upon request.
Comments:
E. Proposed Labeling (see also 21 CFR parts 801 and 809 as applicable)
19. Submission includes proposed package labels and labeling (e.g., 
instructions for use, package insert, operators manual).
a. All changes in proposed labeling resulting from device 
modification(s) are highlighted or prominently identified.
FDA recommends clean and redlined copies be provided.
Comments:
Digital Signature Concurrence Table
Reviewer Sign-Off
Management Sign-Off
(digital signature 
optional)*
*Management review of checklist and concurrence with decision required.
102