Contains Nonbinding Recommendations
Acceptance and Filing Reviews for 
Premarket Approval Applications 
(PMAs)
Guidance for Industry and Food and 
Drug Administration Staff
Document issued on December 16, 2019.
Document originally issued on May 1, 2003.
This document supersedes Acceptance and Filing Reviews for Premarket 
Approval Applications (PMAs), dated February 21, 2019.
For questions about this document regarding CDRH-regulated devices, contact the Office of 
Regulatory Programs at 301-796-5640. For questions about this document regarding CBER-
regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 
1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
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-0524. 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 
1792 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 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov, or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.
2 Contains Nonbinding Recommendations
Acceptance and Filing Reviews for 
Premarket Approval Applications 
(PMAs)
Guidance for Industry and Food and 
Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
the Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You may use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction 
As discussed in more detail below, the PMA regulation (21 CFR 814.42(e)) identifies the criteria 
that, if not met, may serve as a basis for refusing to file a PMA.  This guidance is intended to be 
used by FDA staff and the device industry to help elucidate the broad preclinical and clinical 
issues that need to be addressed in a PMA and the key decisions to be made during the filing 
process.
Focusing the Agencys review resources on complete applications 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 2017,1 FDA agreed to performance goals based on the timeliness of reviews.  
Acceptance review therefore takes on additional importance in both encouraging quality 
applications from PMA applicants and allowing the Agency to appropriately concentrate 
resources on complete applications. 
Therefore, we have modified the PMA filing guidance and checklist.  We have separated the 
criteria for PMA filing into 1) acceptance criteria and 2) filing criteria.  Acceptance review 
involves assessment of the completeness of the application, and informing the applicant in a 
1See Title II of the FDA Reauthorization Act of 2017 (Public Law 115-52)
3 Contains Nonbinding Recommendations
written response within the first 15 calendar days of receipt2 of the application by the document 
control center (DCC) whether any elements are missing, and if so, identifying the missing 
element(s).  In order to enhance the consistency of our acceptance and filing decisions and to 
help applicants better understand the types of information FDA needs to conduct a substantive 
review of a PMA, this guidance and associated checklist clarify the necessary elements and 
contents of a complete PMA application.  The process we outline is applicable to all devices 
reviewed in a PMA application and has been compiled into a checklist for use by FDA review 
staff.
FDA staff and industry should note that this guidance is not significantly different from the 
previous PMA filing checklist and guidance document, as the PMA filing criteria defined in the 
regulation have not changed.  The preliminary questions remain the same and the filing 
review questions have been separated into acceptance decision questions (i.e., whether the 
file is administratively complete) and filing decision questions (i.e., determine the basic 
adequacy of the technical elements of the PMA).  In the 2003 PMA Filing Guidance, we stated 
that delayed submission of the manufacturing section would not preclude filing a PMA, and, if 
this section was not included in the original PMA application, recommended submitting this 
section within 90 days.  However, delayed submission of the manufacturing section has rarely 
occurred in recent years, and in many cases this section is submitted prior to other sections of the 
PMA, as part of a modular PMA application.  Therefore, we are now including the 
manufacturing section in the checklist for a complete PMA application for an original PMA or a 
panel-track supplement (with a new manufacturing site or substantially different manufacturing 
procedures).
FDA requires all applicants to provide one electronic copy (eCopy) of the PMA application. The 
eCopy must be accompanied by a single paper copy of your signed cover letter.  FDA has issued 
guidance3 to implement Section 745A(b) of the FD&C Act, added by section 1136 of FDASIA, 
which provides statutory authority to require an eCopy for most submissions, including original 
PMAs and PMA supplements.  With the implementation of this provision, a valid eCopy is 
required in order for a PMA or PMA supplement to be processed and for the acceptance review 
to begin. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidance documents means that something is 
suggested or recommended, but not required.
2There are three (3) criteria for not processing a PMA that has been received: i) the application is not submitted with 
the required user fee and user fee payment identification (ID) number (provided on the MDUFA User Fee Cover 
Sheet (Form 3601), the application cover letter, or the CDRH Premarket Review Submission Cover Sheet (Form 
3514) per the Medical Device User Fee Amendments of 2012, ii) the application is not signed or countersigned by a 
U.S. representative per 21 CFR 814.20(a), and iii) the firm did not submit the correct number of copies per 
814.20(b)(2). Since any PMA not meeting these three criteria will not be processed by the CDRH Document Mail 
Center or CBER Regulatory Project Manager, they are not included in the checklist.
3See the guidance eCopy Program for Medical Device Submissions, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.  .  
4 Contains Nonbinding Recommendations
II. Purpose 
The purpose of the PMA acceptance and filing reviews is to make a threshold determination 
about whether an application is administratively complete for the Agency to undertake a 
substantive review.  The PMA regulation (21 CFR 814.42(e)) states that FDA may refuse to file 
a PMA if any of the following applies:
(1) The PMA is incomplete because it does not on its face contain all the information required 
under section 515(c)(1)(A)-(G) of the FD&C Act.
(2) The PMA does not contain each of the items required under section 814.20 and justification 
for omission of any item is inadequate.
(3) The applicant has a pending premarket notification under section 510(k) of the FD&C Act 
with respect to the same device, and FDA has not determined whether the device falls within the 
scope of section 814.1(c).
(4) The PMA contains a false statement of material fact.
(5) The PMA is not accompanied by a statement of either certification or disclosure as required 
by 21 CFR Part 54.
Section 814.20 of the regulation further specifies that PMAs must include, among other things, 
technical sections which shall contain data and information in sufficient detail to permit FDA to 
determine whether to approve or deny approval of the application (21 CFR 814.20(b)(6)).  
FDA staff has frequently expressed the need for more specific guidance in applying this 
regulatory standard to the PMA application filing decision-making process.
The goal of this document is to clarify the criteria for accepting and filing a PMA, thereby 
enhancing the consistency of our acceptance and filing decisions.  The decision-making process 
presented in this document is captured in Checklists for Acceptance and Filing of PMAs, (see 
Appendix A). FDA staff will use these checklists during the acceptance and filing review 
processes.
III. Scope 
The information presented in this document is intended to provide FDA staff with a clear, 
consistent approach to making acceptance and filing decisions on original PMA applications4
and panel-track PMA supplements.  FDAs decision to accept and/or file a PMA does not imply 
4An acceptance and filing review will be conducted on modular PMAs at the time of receipt of the final clinical 
module, which completes the PMA application, and will be an assessment of all information in all modules received 
to date. Please refer to the guidance document entitled Premarket Approval Application Modular Review, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-approval-
application-modular-, for additional information regarding Modular PMAs.
5 Contains Nonbinding Recommendations
that the data provided in the PMA demonstrate reasonable assurance of the safety and 
effectiveness of your device or assure approval of the PMA.
In addition, it should be noted that this document is focused on the regulatory and scientific 
criteria for making an Accept or Refuse to Accept (RTA) decision as well as File or Not 
File decision for a PMA.  It specifically does not alter the following administrative aspects of 
the PMA filing process:  the time frame for the filing review phase (i.e., 45 days which includes 
the time spent conducting the acceptance review); the processes for document tracking, 
distribution, and handling; and the procedures for assembling the review team and setting up the 
filing meeting.
This document does not discuss the statutory criteria for Breakthrough Device designation.5
Information pertaining to this designation can be found in the guidance Breakthrough Devices 
Program6 published on December 18, 2018.
  
This document does not address the monetary aspects or the MDUFA goals associated with 
PMAs.  For information pertaining to the fees and payment procedures for submission of a PMA, 
please refer to theMedical Device User Fees webpage.7
IV. Q-Submission Interaction 
Prior to interacting with review staff, applicants should consult CDRHs Division of Industry and 
Consumer Education (DICE) or CBERs Manufacturers Assistance and Technical Training 
Branch for general information regarding the PMA regulations.  Before submitting a PMA, we 
encourage applicants to interact with FDA review staff.  Such Q-submission interaction is an 
important way of improving the quality and completeness of a PMA.  A face to face meeting 
with FDA staff may be useful for applicants prior to preparing the PMA to discuss issues related 
to their specific device and PMA.  For additional information regarding the Q-Submission 
Program, please refer to the guidance Requests for Feedback on Medical Device Submissions: 
The Q-Submission Program.8
In addition, CDRHs Device Advice,9 as well as other applicable CDRH device-specific and 
cross-cutting guidance documents,10 provide valuable information for preparing PMAs.
5See section 515B of the FD&C Act
6Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-
program. 
7Available at https://www.fda.gov/medical-devices/premarket-submissions/medical-device-user-fees.
8Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program. 
9Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance.
10Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-
documents-medical-devices-and-radiation-emitting-. 
6 Contains Nonbinding Recommendations
V. Basic Review Policies and Procedures 
Review policies for acceptance
To facilitate a more efficient review process, FDA staff will conduct an acceptance review of all 
original PMAs and panel-track PMA supplements11 based on objective criteria using the 
Checklist for Acceptance Review (see Appendix A) to ensure that the PMA is administratively 
complete.  In order for the application to be accepted, all organizational and administrative 
elements should be present or a rationale should be provided for those elements determined by 
the applicant to be not applicable.  The acceptance review should be conducted and completed 
within 15 calendar days of the Agency receiving the PMA application.  An acceptance review 
will only begin for PMAs for which the appropriate user fee has been paid and a validated eCopy 
has been received.12
If the application contains all of the information outlined in the checklist, FDA staff should 
notify the applicant electronically that it has been Accepted and proceed to the filing review.  
Should FDA fail to complete the acceptance review within 15 calendar days, the application 
should be considered accepted, the applicant should be notified electronically, and FDA should 
commence with the filing review. In the case of a government closure during the 15-day review 
period, the review period may be extended by a comparable number of business days that the 
FDA buildings are closed.  If the applicant receives an automated notice that the acceptance 
review was not completed because the acceptance review period has exceeded 15 days, FDA 
may send a correction notice to the applicant. In such cases, if the application is accepted and 
filed, the extended acceptance review period would not otherwise impact the performance goal 
for a MDUFA decision on the application.
If one or more of the items on the Inventory of Organizational and Administrative Elements 
within the Acceptance Checklist are not present, the lead reviewer conducting the acceptance 
review should obtain division concurrence that the application should be designated RTA and 
notify the designated PMA contact person electronically that the application has not been 
accepted.  FDA staff should also provide the applicant with a copy of the completed acceptance 
checklist indicating which item(s) are the bases for the RTA designation.
The PMA applicant may respond to the RTA notification by providing the missing information 
identified in the checklist.  The applicant should submit this information to be included in the file 
(i.e., as an amendment) under the originally assigned PMA number.  A new application and new 
user fee are not necessary.  Nor should the applicant re-send the entire PMA application, unless 
FDA determines otherwise (e.g., because the majority of the application was not in English, or 
the application pages were not numbered).  It is sufficient to submit and address only the 
information requested per the acceptance checklist.  
11Available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-
subject-premarket-approval-pma-pma-supplement-decision-making-process. 
12For additional information, please see the guidance FDA and Industry Actions on Premarket Approval 
Applications (PMAs): Effect on FDA Review Clock and Goals available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-
fda-review-clock-and-. 
7 Contains Nonbinding Recommendations
Upon receipt of the newly submitted information, FDA staff should conduct the acceptance 
screening again following the same procedure within 15 calendar days of receipt.  If the 
application is still found to be incomplete, FDA staff should notify the contact person and 
provide the new checklist indicating the missing item(s).  This cycle will continue until the PMA 
is found to be administratively complete.
Review policies for filing
Once the application is found to be administratively complete, FDA staff should notify the 
applicant that the PMA has been accepted and begin the filing review according to the Checklist 
for Filing Review.  The objective of the filing review is to determine the basic adequacy of the 
technical elements of the PMA.  In order for the application to be filed, the application should be 
sufficiently complete to permit a substantive review.  Once the filing review is complete, staff 
will notify the applicant electronically within 45 calendar days of receipt whether the PMA has 
been Filed or Not Filed.  See 21 CFR 814.42(a).  If the PMA has been Filed, the agency 
will identify the date of receipt of the PMA or of the amendment to the PMA that enabled FDA 
to file the PMA.
The PMA applicant may respond to the Not Filed notification by providing the missing 
information identified in the letter.  The applicant should submit this information to be included 
in the file (i.e., as an amendment) under the originally assigned PMA number.  Upon receipt of 
the newly submitted information, FDA staff should conduct the filing review again following the 
same procedure within 45 calendar days of receipt.  
During the filing review, review staff may ask for any information that should have resulted in 
an RTA designation during the acceptance review.  Likewise, once the application has been 
filed, FDA may ask for any information during the substantive review that may have been 
unintentionally overlooked during the acceptance or filing reviews.  
FDA Review Clock
As explained in section VIII.D. of the commitment letter for MDUFA IV referenced in Title II of 
FDASIA, Public Law 112-114, 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).13  Since the PMA acceptance criteria are a subset of the PMA filing criteria under 21 
CFR 814.42, an application that is Not Accepted is not one that enables the application to be 
filed.  Thus, the FDA review clock does not start when an application is placed on eCopy or user 
fee hold or is designated Not Accepted or Not Filed.  Once FDA has both Accepted and 
Filed an application, the FDA review clock begins as of the date of receipt of the most recent 
application or amendment that made the PMA complete and on which the FDA based its 
Accepted and Filed decisions.  This date will not change even if FDA later requests 
information it should have requested during acceptance or filing review.  
13See 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
8 Contains Nonbinding Recommendations
VI. Combination Product Administrative Items 
 
The 21st Century Cures Act, which amended section 503(g) of the FD&C Act, requires 
applicants seeking action on a combination product to identify the product as such [ 
503(g)(8)(C)(v)]. Additionally, per the amended section 503(g)(5), applications 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).  Applicants 
of products that are not combination products, as defined in 21 CFR 3.2(e), should mark N/A to 
question 14 of the acceptance checklist and omit this section pertaining to combination products.
Applicants 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), applicants of device-led, device-drug combination products should mark 
N/A for question 14b.
Applicants of Combination Products That Contain as a Constituent Part an Approved Drug
Applicants of combination products containing as a constituent part an approved drug should 
address question 14 by including patent information.  For each relevant patent, the applicant 
should include certification to one of the following certifications:
i. That such patent information has not been filed (505(b)(2)(A)(i)).
ii. That such patent has expired (505(b)(2)(A)(ii)).
iii. The date on which the patent will expire (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 application is made (505(b)(2)(A)(iv)). 
However, for a method of use patent which does not claim a use for which the applicant is 
seeking approval, the applicant should include a statement per section 505(b)(2)(B) that the 
method of use patent does not claim such a use. 
Applicants including a certification under paragraph iv (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.  Applicants should submit to FDA documentation of the 
date of receipt of notice by holder of the approved application and patent(s) owner.  
VII. Acceptance and Filing Review Principles 
In order to use this guidance appropriately, FDA staff should review the following basic 
principles in bold followed by a description of FDAs review policies and procedures.  These 
principles, and the objective criteria outlined in the Acceptance and Filing Checklists, inform 
FDAs PMA acceptance and filing decisions.
9 Contains Nonbinding Recommendations
The contents of the PMA should allow the substantive review to proceed
The PMA must contain the basic administrative and scientific elements listed in 21 CFR 814.20.
The specific questions in the acceptance and filing checklists are intended to help FDA ensure 
that the PMA contents are not so disorganized or incomplete so as to prevent the review team 
from proceeding with a substantive review of the application.
The acceptance decision and filing decision should not be based on a substantive review of 
the data and information in the PMA
The acceptance review and filing review are conducted to ensure that the PMA is 
administratively complete and to determine the basic adequacy of the technical elements of the 
PMA, respectively.  Notably, in determining whether a PMA should be accepted and filed, the 
submitted information should not be evaluated to determine whether there is a reasonable 
assurance of safety and effectiveness.  The checklist is a tool to ensure that the application 
contains the necessary information in order to conduct a substantive review (i.e., FDA should not 
designate an application Refuse to Accept or refuse to file a PMA because we have reviewed 
the data and believe that the application is ultimately not approvable).  Subsequently, the 
substantive review of the PMA will evaluate the quality of the content and lead to a decision 
regarding the safety and effectiveness of the PMA product.
Concerns identified by the Agency during the acceptance or filing review regarding results and 
outcomes of nonclinical and clinical studies would not preclude acceptance or filing.  
Examples of information that would typically fall into this category include:
  demographic information for the study population
  conclusions regarding statistical analyses
  report or assessment of protocol deviations
  reports of device failures or malfunctions.
Staff should determine whether the applicant provided a justification for any alternative 
approach
If the applicant believes any criteria in the checklist are not applicable, it should explain its 
rationale. Likewise, the applicant should provide a rationale for any deviation from a device-
specific or cross-cutting guidance document or FDA-recognized standard. It is FDAs 
expectation that any item in the checklist that is missing will be addressed with a rationale 
explaining why it is not applicable and that any deviations will be explained. 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 
10 Contains Nonbinding Recommendations
application.  A given criterion in the checklist will be considered Not Present if the application 
fails to include either the information requested or a rationale for omission. See Acceptance 
Review section below for further explanation.
PMA acceptance and filing reviews
The decision to Accept an application or designate it Refuse to Accept should be made by 
the lead reviewer with concurrence from the immediate supervisor or designee.  The decision to 
File or Not File a PMA should be made at the division level in collaboration with the PMA 
review team (e.g., the medical officer and statistician) and the appropriate managers in the 
reviewing division(s).  
VIII. The Checklist  Preliminary Questions 
Within 15 calendar days of receipt of the PMA by DCC and prior to the filing review, the PMA 
lead reviewer should answer the preliminary questions below, and complete the Inventory of 
Organizational and Administrative Elements within the Administrative Checklist to make an 
Acceptance Decision. 
 
The preliminary questions are included on the first page of the Checklists for Accepting and 
Filing PMAs and are intended to be answered by the lead reviewer as an initial screening of the 
application.  FDA does not intend for the applicant to have addressed these items in their 
application.  Depending upon the answers to these preliminary questions, the remainder of the 
acceptance and filing reviews may or may not be necessary.  If the lead reviewers responses to 
the preliminary questions and subsequent consultation with the Center personnel identified 
below indicate that the PMA acceptance and filing reviews should not continue, the lead 
reviewer should promptly:
  inform the PMA review team (including consulting reviewers); and
   notify the applicant 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 under PMA?
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 
subject to review under PMA, then the lead reviewer should consult with the CDRH Product 
Jurisdiction Officer or the CBER Product Jurisdiction Officer to determine the appropriate 
action, and inform division management.  If they agree that the product does not appear to be 
a device or a combination product with a device constituent part subject to review under 
PMA, the PMA review team should stop the review and notify the applicant.
11 Contains Nonbinding Recommendations
2.  Is the application with the appropriate Center?
If the application 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 lead reviewer should consult with the CDRH Product Jurisdiction 
Officer or the CBER Product Jurisdiction Officer to determine the appropriate action and 
inform division management.  If the PMA is submitted to CDRH and CDRH staff determines 
that the application is not subject to CDRH review, or the PMA is submitted to CBER and 
CBER staff determines that the application is not subject to CBER review, the PMA review 
team should stop the review and notify the applicant electronically.
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:
 Is the device or combination product the same (e.g., design, formulation) as 
that presented in the RFD submission?
 Are the indications for use for the device or combination product identified in 
the PMA 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 lead reviewer should 
consult with the CDRH Product Jurisdiction Officer or the CBER Product Jurisdiction 
Officer to determine the appropriate action and inform division management.    
4.  Is the application 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 21 USC 503(g)(5)(C)(ii)-(v) (section 503(g)(5)(C)(ii)-(v) of the FD&C 
Act)?
If the application 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 21 USC 
503(g)(5)(C)(ii)-(v), the lead reviewer should contact the CDRH Product Jurisdiction 
Officer or CBER Product Jurisdiction Officer to determine the appropriate action and 
inform division management. 
5.  Is class III/PMA review required for the device?
Our goal is to apply the appropriate level of regulation to provide a reasonable assurance of 
safety and effectiveness.  Therefore, early in the filing review process, FDA should consider 
the regulatory burden and the available mechanisms to apply the proper degree of regulation.  
In making this determination, staff should consider how similar devices are being regulated.
12 Contains Nonbinding Recommendations
Class III devices are those that cannot be classified as Class I or Class II devices because 
insufficient information exists to determine that general and special controls are sufficient to 
provide reasonable assurance of the safety and effectiveness of the device, and either (1) are 
purported to be for a use in supporting or sustaining human life or for a use which is of 
substantial importance in preventing impairment of human health; or (2) present a potential 
unreasonable risk of illness or injury.  See section 513(a)(1)(C) of the FD&C Act.  Devices 
may also automatically be classified in class III under section 513(f)(1) of the FD&C Act. 
Generally, PMA review is required if the device is:
  a transitional device that has not been reclassified (see section 520(l) of the FD&C 
Act),
  the subject of a final call for PMA under section 515(b) of the FD&C Act, or
   automatically classified into Class III under section 513(f) of the FD&C Act, including 
devices found to be Not Substantially Equivalent (NSE) in response to a 510(k) 
premarket notification and/or for which a request for reclassification under 513(f)(2) 
has been denied by FDA. 
 
If regulation under PMA does not appear to be required, the PMA lead reviewer should 
consult division management and other Center resources to determine the appropriate action.  
If the review division agrees that review in a different type of marketing application may be 
an option, the PMA review team should notify the applicant to discuss the most appropriate 
path forward.
6.  Is there a pending 510(k) for the same device with the same indications for use?
FDA may decide not to file a PMA if the applicant has a 510(k) for the same device with the 
same indications for use pending (21 CFR 814.42(e)(3)).  If there is a pending 510(k), the 
review team should stop the review.  The lead reviewer should consult division management 
and other Center resources to determine which premarket review pathway applies to the 
device and the appropriate processes for addressing the situation.  Staff should also consult 
division management and other Center resources if a 510(k) and PMA have been submitted 
for the same device type by different applicants.  
7.  Is the applicant the subject of the Application Integrity Policy (AIP)14?
The lead reviewer should refer to the AIP list.15  If the applicant is on the list, the reviewer 
should consult the CDRH Office of Product Evaluation and Quality/Office of Clinical 
14When data in a pending application has 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).
15Available athttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/application-
integrity-policy/application-integrity-policy-list. 
13 Contains Nonbinding Recommendations
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.
IX. The Checklist  Acceptance Review 
If the answers to the above preliminary questions indicate that PMA review should continue, the 
acceptance review should proceed by answering questions in the Acceptance Review section 
of the checklist.  This section of the checklist collects information regarding the completeness of 
the PMA (i.e., Inventory of Organizational and Administrative Elements) and guides FDA 
staff through the process necessary to arrive at a decision to Accept a PMA or designate it 
Refuse to Accept. 
  
The specific issues that are critical to the PMA acceptance decision-making process (i.e., the 
Acceptance Decision Questions) are individually discussed below.  The numbering scheme 
used for these decision questions corresponds to the checklist.  Each Acceptance Decision 
Question should be answered.  Only if all questions are answered Yes can the PMA 
application be accepted for filing review.
Acceptance Decision 1:  Is the PMA administratively complete?
The questions in Section A of the checklist are intended to outline each of the 
administrative elements required by 21 CFR 814.20 that are necessary for substantive 
review of the PMA.  If, on its face, the PMA is missing one or more required elements or 
sections as described by the questions in Section A (including manufacturing information 
as discussed above), the answer to the above question is No and the lead reviewer should 
note the specific omission(s) on the checklist.  A section will be considered missing if it is 
not in English or  not accompanied by an English translation.  If such omissions exist, the 
FDA should not accept the PMA.
Acceptance Decision 2:  From only an administrative review, does the PMA include data 
that appears to constitute valid scientific evidence?
The answer to this question is No if it is clear that the only information provided in the 
PMA is information that is not regarded as valid scientific evidence under 21 CFR 860.7 
(i.e., isolated case reports, random experience, reports lacking sufficient details to permit 
scientific evaluation, and unsubstantiated opinions).  If none of the data, on their face, 
constitute valid scientific evidence, the PMA should not be accepted.  
Acceptance Decision 3:  Does the PMA address the key nonclinical and clinical issues 
identified by FDA prior to submission of the PMA application, OR 
has the applicant provided a scientific or clinical justification for 
an alternative approach?
14 Contains Nonbinding Recommendations
Section B of the checklist outlines questions intended to identify when the FDA has 
previously provided specific guidance to the applicant about the content of the PMA 
through one or more mechanisms, such as a prior PMA application, a prior Not 
Substantially Equivalent decision on a 510(k), Investigational Device Exemption (IDE) 
letters, Q-Submission feedback, a Determination or Agreement meeting(s), or other 
substantive communication with FDA, or through a published guidance document.  If such 
information has been communicated to the applicant through one or more of these 
mechanisms, and the PMA application addresses each of the key nonclinical and clinical 
issues identified by FDA, the answer to the above question is Yes.  Furthermore, if some 
of these key issues previously identified by FDA are not addressed, but the PMA 
application contains a scientific or clinical justification for the omission or deviation, the 
answer to the above question is Yes.  If the PMA application contains a statement that 
there were no prior submissions for the device, the answer to the above question is Yes.   
These cases do not preclude the review division from accepting the PMA.
In this context, the term key issues is meant to refer to issues that are central to our 
review of device safety and effectiveness under section 515(c) and (d) of the FD&C Act.  
Examples of key issues include:  need for long-term nonclinical studies (e.g., 
biocompatibility, carcinogenicity, or other animal studies), and certain clinical trial 
parameters (e.g., sample size, patient population, statistical hypothesis, study design, and 
endpoints).  These key issues typically are device-specific.  As a result, the decision of the 
review division to Refuse to Accept a PMA application based on this criterion can only 
be made after carefully considering the following questions:
Are the types of necessary nonclinical and clinical studies well-known in the scientific and 
medical communities for the particular device?
For an established device type, the types of nonclinical and clinical studies that we would 
expect in a PMA are likely to be well-known both within FDA and in the scientific and 
medical communities and, as such, are often included as part of an FDA guidance 
document and/or consensus standard.  If citing voluntary consensus standards, the applicant 
should consider FDAs guidance Appropriate Use of Voluntary Consensus Standards in 
Premarket Submissions for Medical Devices.16
Were the issues conveyed to the applicant as part of a documented regulatory process?
Examples of a documented regulatory process include:
 Q-submission interaction, 
 
 prior PMA application, 
 
 prior Not Substantially Equivalent decision on a 510(k), 
 
16Available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
15 Contains Nonbinding Recommendations
  IDE letters, or
  letter(s) issued as a result of Determination or Agreement meetings.
Staff should only designate a PMA Refuse to Accept based on a No response to 
Acceptance Decision 3 in instances where the key issues were identified by staff as part 
of a documented regulatory process.
X. The Checklist  Filing Review 
If the answers to the above preliminary questions and acceptance decision questions indicate that 
PMA review should continue, the formal filing review should proceed by answering questions in 
the Filing Review section of the checklist.  This section of the checklist assesses the basic 
adequacy of the technical elements (i.e., Filing Assessment of Technical Elements) and guides 
FDA staff through the process necessary to arrive at a decision to File or Not File a PMA. 
 
The specific issues that are critical to the PMA filing decision-making process (i.e., the Filing 
Decision Questions) are individually discussed below.  The numbering scheme used for these 
decision questions corresponds to that of the checklist.  Each Filing Decision Question should be 
answered.  Only if all questions are answered Yes can the PMA application be filed.
We do not anticipate that a single member of the PMA review team will be able to answer all of 
these questions.  Rather, we expect that the lead reviewer will complete this checklist in 
consultation with the team members, in particular the medical officer and statistician.
Filing Decision 1:  Were the clinical study data collected and analyzed per the protocol?
If the clinical data submitted in support of PMA approval appear, on an administrative 
review, to have been collected and analyzed consistent with the major elements of the 
clinical protocol (i.e., objectives, study population, endpoints, study design, hypothesis, 
sample size, and follow-up duration), or the applicant provides a scientific or clinical 
justification for the use of an alternative approach, the answer to the above question is 
Yes and the lead reviewer will note any specific deviations or justifications on the 
checklist.  In addition, if the sample size is smaller or the follow-up duration is shorter than 
specified in the clinical protocol, but such changes are supported by either: (i) the 
recommendation of a Data Monitoring Committee (DMC) or (ii) statistical plans that 
incorporate interim stopping rules, substantive review of the PMA may proceed.  That is, 
these cases do not preclude the FDA from filing the PMA.
If the study deviated from the clinical protocol with respect to the major elements identified 
in the paragraph above and the applicant provided no justification for doing so, the answer 
to the above question is No and the lead reviewer will note the specific deviation(s) on 
the checklist.  In these cases, the FDA should not file the PMA.
16 Contains Nonbinding Recommendations
As discussed above, occasionally, applicants have submitted PMAs with incomplete 
clinical data (i.e., the sample size is smaller or follow-up duration for the primary analysis 
is shorter than specified in the clinical protocol).  If no justification is provided and/or the 
applicant indicates they intend to update the PMA with necessary additional clinical data, 
we will consider such PMAs to be submitted prematurely and therefore incomplete.  If the 
PMA is viewed as a premature application, the answer to the above question is No.  In 
these cases, the FDA should not file the PMA.
Filing Decision 2:  Were the nonclinical and clinical data collected on the final design of 
the device (i.e., the device design intended to be marketed)?
If the nonclinical and pivotal clinical data submitted in support of PMA approval were 
collected on the final device design, or the differences between the study device and final 
device clearly do not affect safety or effectiveness of the device and/or clinical outcome, 
the answer to the above question is Yes and any device changes will be noted on the 
checklist.  Furthermore, if the clinical data were collected on an earlier design of the device 
and the applicant provides a scientific or clinical justification describing why the study 
results on the earlier device design apply to the proposed design, the answer to the above 
question is Yes and the justification will be noted on the checklist.  These cases do not 
preclude the FDA from filing the PMA.
If changes that could potentially impact safety and/or effectiveness were made to the device 
design either during or after the pivotal nonclinical and clinical studies, and no justification 
is provided as to why these data are applicable to the new design, the answer to the above 
question is No.  In this case, the lead reviewer will note the specific device change(s) on 
the checklist, and the FDA should not file the PMA.
Filing Decision 3:  Were the patient/study17 population and endpoints consistent with the 
proposed indications?
If, upon an administrative review, the patient population (as defined by the inclusion and 
exclusion criteria) in the pivotal study appears to match the devices proposed indications 
for use and the endpoints that were selected were agreed to by FDA and/or appear to be 
clinically relevant, the answer to the above question is Yes.  Additionally, if the patient 
population and/or endpoints are inconsistent with the proposed indications but the 
applicant provides a detailed scientific or clinical justification for this approach, the answer 
to the above question is Yes.  These cases do not preclude the FDA from filing the PMA.
If either the patient population or endpoints of the pivotal study, on their face, do not 
match the proposed indications for use and no justification is provided for this alternative 
approach, the answer to the above question is No.  In addition, if the pivotal study was 
conducted outside the U.S. and the applicant has not addressed how such data are adequate 
to support approval (including addressing how the local medical practice and/or patient 
population match those of the U.S. or why any differences would not impact the 
17Note that in the case of PMAs submitted to CBER, the study population may be blood donors rather than patients.
17 Contains Nonbinding Recommendations
applicability of the study results to the U.S. patient population), answer No to the above 
question.  In these cases, the PMA should not be filed.
18 Contains Nonbinding Recommendations
Appendix A. Checklists for Acceptance and Filing of PMAs
Checklist for Acceptance Review for PMAs
(should be completed within 15 days of DCC receipt)
PMA Number:  _____________   Date Received:  __________
Device:  _______________________________  Procode:  __________
Company Name/ Address:  ____________________________________________
Contact Name/Phone Numbers:  _____________________________________________
Lead Reviewer Name: ___________________________________________
 
Preliminary Questions
Answers in the shaded blocks indicate consultation with an identified Center advisor is  Yes No
needed, as described at the end of this table.  (Boxes checked in this section represent FDAs 
preliminary assessment of these questions at the time of administrative review.)
1. Is the product a device (per 201(h) of the FD&C Act) or a combination product with a device     
constituent part subject to review under PMA?  If it appears not to be a device or such a 
combination product, or you are unsure, consult with the CDRH Product Jurisdiction Officer 
or CBER Product Jurisdiction Officer to determine the appropriate action and inform your 
division management.  Provide summary of Product Jurisdiction Officers determination.   
 
If the product does not appear to be a device or such a combination product, mark No. 
2. Ifthe product is a device or a combination product with a device constituent part, is it     
subject to review by the Center in which the application was received?  If you believe the 
application is not with the appropriate Center or you are unsure, consult with the CDRH 
Product Jurisdiction Officer or CBER Product Jurisdiction Officer to determine the 
appropriate action and inform your division management.  Provide a summary of the 
Product Jurisdiction Officers determination.   
 
If application should not be reviewed by your Center, mark No. 
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: 
  Is the device or combination product the same (e.g., design, formulation) as that 
presented in the RFD submission?
 Are the indications for use for the device or combination product identified in the 
PMA the same as those identified in the RFD submission?
If you believe the product or the indications presented in the PMA have changed from the 
RFD, or you are unsure, consult with the CDRH Product Jurisdiction Officer or appropriate 
CBER Product Jurisdiction Officer to determine the appropriate action and inform your 
division management.  Provide summary of Product Jurisdiction Officers determination.  
If the answer to either question above is no, mark No. 
19 Contains Nonbinding Recommendations
4. Is the application 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 21 USC 
503(g)(5)(C)(ii)-(v) (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, provide a 
summary of the discussion with them, and indicate their recommendation/action. 
5. Is class III/PMA review required for the device?   
 
         NOTE:  If you believe an application is for a new type of device for which we have never 
received a marketing application and is thus class III/PMA, you should (1) document why 
the device would be found NSE and (2) obtain concurrence from the 
CDRH/OPEQ/ORP/Division 1   or appropriate CBER staff prior to the accepting the original 
PMA.  Attach a copy of the 510(k) Staffs concurrence.
6. Is there a pending 510(k) for the same device with the same indications for use?  The     
regulations allow FDA to refuse to file a PMA if a 510(k) for the same device is pending (21 
CFR 814.42(e)(3)). 
7. Is the applicant 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.  Check on web 
at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/application-integrity-policy/application-integrity-policy- 
If the answer to 1 or 2 appears to be No, then stop review of the PMA and contact the CDRH Product Jurisdiction Officer 
or CBER Product Jurisdiction Officer.
If the answer to 3 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 PMA lead reviewer should consult division management and other Center resources to determine 
the appropriate action.  
If the answer to 6 is Yes, then stop review of the PMA, contact the CDRH/OPEQ/ORP/Division 1, or appropriate CBER staff.
If the answer to 7 is Yes, then contact CDRH Office of Product Evaluation and Quality/Office of Clinical Evidence and 
Analysis/Division of Clinical Science and Quality (OPEQ/OCEA/DCEA1) or CBER/OCBQ/DIS/BMB, provide a summary of 
the discussion with the BIMO Staff, and indicate BIMOs recommendation/action.
20 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
A. PMA Content
1. Are all required sections in English or accompanied with an English 
translation?   
2. Is there a table of contents? 
3. Is a bibliography provided? 
a. Have copies of key articles been provided and are English 
translations included, if appropriate?
Check N/A if applicant includes a statement that upon searching 
they found no literature related to their device
4. If a device sample has been requested by FDA, has it been provided or if 
impractical to submit, has the applicant offered alternatives to allow 
FDA staff to view or access the device? 
5. Is there a summary of the contents of the PMA?
6. Device Characteristics
a. Is a description of device included? 
i. Pictorial representations?
ii. Materials specifications?
 If there is a color additive present:
 has the color additive been identified by common 
name and chemical name, and
 has the amount of each color additive in the 
formulation by weight percent of the colored 
component and total amount (e.g., g, ppm) in the 
device been provided?
21 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
b. Is a description of the principles of operation of the device 
(including components) and properties relevant to clinical 
function present? 
7. Is the Device Manufacturing Section included? (see the guidance entitled 
Quality System Information for Certain Premarket Application 
Reviews, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/quality-system-information-
certain-premarket-application-reviews.
For original PMA or a panel-track supplement with a new manufacturing 
site or substantially different manufacturing procedures.
a. Has a description of the methods, facilities, and controls used in the 
manufacture, processing, packing, storage, and installation of the 
device been provided? 
8. Are summaries of the nonclinical laboratory studies and full test reports* 
provided? 
Note:  the applicant can reference data located in other submissions.  
Check Yes if nonclinical data is not provided in the current 
submission, but found in another submission.  State where the data were 
provided (e.g., modular submission, licensing PMA).
*Full test report includes objective of the test, description of test 
methods and procedures, study endpoint(s), pre-defined pass/fail criteria, 
results summary, discussion of conclusions)
a. Sterilization
b. Biological/Microbiological
c. Immunological
d. Toxicological/Biocompatibility
e. Engineering (stress, wear, etc.)
22 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
f. Chemistry/Analytical (typically for IVDs)
g. Shelf Life
h. Animal Studies
i. Other Essential Laboratory Testing
9. Is a summary of the clinical investigation(s) and results provided?
a. Are the final versions of the clinical protocols included? (If 
performed under IDE, these should be the final FDA-approved 
versions of the clinical protocols, incorporating any Notices of 
Changes.)
b. Is a description of study population demographics provided?
c. Is a description of adverse events (e.g., adverse reactions, 
complaints, discontinuations, failures, replacements) given?
d. Have report forms for patients who died or who did not complete 
the investigation been provided (i.e., to resolve potential bias)?  
Check N/A only if no patients died or were discontinued.
10. Are statistical analyses of the clinical investigations provided?
a. Are the results of all analyses identified in the protocol provided?
11. Has appropriate draft labeling been submitted? 
a. Physician Labeling
i. Are indications for use included?
ii. Are contraindications, warnings, and precautions included?
iii. Are instructions for use included?
23 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
b. Patient Labeling 
Check N/A only if CDRH has indicated that patient labeling is 
not necessary.  
c. Technical/Operators Manual
12. Statements/Certifications/Declarations of Conformity
a. Does the application utilize 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.
i. If the application cites FDA-recognized voluntary consensus 
standard(s), does the application include:
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-devicesOR
if citing general use of a standard, the basis of such use is 
included along with the underlying information or data that 
supports how the standard was used?
ii. If the application cites non-FDA-recognized voluntary 
consensus standard(s), does the application include the basis 
of use along with the underlying information or data that 
supports how the standard was used?
b. Has the applicant provided documentation to establish that it has 
followed the recommendations in applicable FDA guidance/
24 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements  
(21 CFR 814.20 unless otherwise indicated) 
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
guidelines or otherwise met applicable statutory or regulatory 
criteria? 
Check N/A only if no guidance/guidelines are used.   
    c.  Investigator Financial Disclosure        
For additional information refer to the guidance document       
Financial Disclosure by Clinical Investigators, available at       
https://www.fda.gov/regulatory-information/search-fda-guidance-       
documents/financial-disclosure-clinical-investigators.         
       
As required by 21 CFR Part 54, has the applicant submitted either:       
1. A signed and dated Certification Form (3454) or       
       
2. A signed and dated Disclosure Form (3455)       
       
Note:  the signature should be from a responsible corporate official 
or representative of the applicant. 
i.  For a Certification Form (3454):  Is the required list of all       
investigators and subinvestigators attached to the Form?   
ii.  If box 3 is checked, does the Form include an attachment       
with the reason(s) why financial disclosure information could 
not be obtained?   
iii.  For a Disclosure Form (3455):  Does the application provide 
details of the financial arrangements and interests of the 
investigator(s) or subinvestigator(s), along with a description 
of anysteps taken to minimize potential bias?
d. Environmental Assessment under 21 CFR 25.20(n) ((d)(i) or (ii) 
i. If claiming a categorical exclusion, information to justify the 
exclusion, OR
25 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
ii. An environmental assessment (ONLY required for devices 
that present new environmental concerns)
e. Did the application include a completed FORM FDA 3674, 
Certification with Requirements of ClinicalTrials.gov Data Bank? 
(42 U.S.C. 282(j)(5)(B))
Note: Enter the NCT number(s) in CTS or other regulatory 
tracking database
Data from FORM FDA 3674 (mark Yes for the applicable one):
i. No clinical trials referenced in submission.
ii. Requirements are not applicable to referenced clinical trials.
iii. Requirements are applicable and have been met.
f. Statements of Compliance for Clinical Investigations
Select N/A if the application does not contain any clinical data 
from investigations (as defined in 21 CFR 812.3(h)) to demonstrate 
reasonable assurance of safety and effectiveness.
For multicenter clinical investigations involving both United States 
(US) and outside the 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-
26 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements  
(21 CFR 814.20 unless otherwise indicated) 
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed. 
    Any Not Present answer will result in a Refuse to Accept decision.  Present  Not 
  Each element on the checklist should be addressed within the    Present 
application. An applicant may provide a rationale for omission for any  (No) 
Yes  N/A 
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application.  
documents/acceptance-clinical-data-support-medical-device-
applications-and-submissions-frequently-asked, for more 
 
information.
      i.  For all clinical investigations conducted in the US, the       
application includes one of the following for each 
investigation (check all that apply):  
 A statement of compliance with 21 CFR parts 50, 56, and 
812.  
 A brief statement of the reason for noncompliance with 21 
CFR parts 50, 56, and 812. 
Select N/A if the clinical investigations were conducted 
solely OUS. 
      ii.  For all clinical investigations conducted OUS, the application 
includes one of the following for each investigation (check all 
that apply):  
 A statement that the clinical investigations were conducted 
in accordance with good clinical practice (GCP) as described 
in 21 CFR 812.28(a)(1).  
 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.  
 A waiver request in accordance with 21 CFR 812.28(c).
Select N/A if the clinical investigations were conducted 
solely inside the US.
13. Pediatric Use -Per 515A(a)(2) of the FD&C Act, did the application 
include: 
a. A description of any pediatric subpopulations that suffer from the 
disease or condition that the device is intended to treat, diagnose, 
27 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements  
(21 CFR 814.20 unless otherwise indicated) 
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed. 
    Any Not Present answer will result in a Refuse to Accept decision.  Present  Not 
  Each element on the checklist should be addressed within the    Present 
application. An applicant may provide a rationale for omission for any  (No) 
Yes  N/A 
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application.  
or cure, or statement that no pediatric subpopulation exists for the 
disease or condition for which the device is intended.  This 
statement does not mean the device is indicated for treating 
pediatric patients.   
    b.  The number of affected pediatric patients.       
  14.  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.  
    a.  Application identifies the product as a combination product.       
    b.  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 
application. If N/A is selected, part a below is omitted from the 
checklist. 
      i.  The application includes appropriate patent statement or 
certification and a statement that the applicant will give 
notice, as applicable.  See 503(g)(5)(A)&(C).   
B.  Issues Identified by FDA Prior to PMA Application - history of the applicant 
with this device
1. Does the applicant list prior submissions or state that there were no prior 
submissions?
(may be located in CDRH Coversheet Form 3514, Section F)
28 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements
(21 CFR 814.20 unless otherwise indicated)
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed.
 Any Not Present answer will result in a Refuse to Accept decision. Present Not 
 Each element on the checklist should be addressed within the  Present
application. An applicant may provide a rationale for omission for any  (No)
Yes N/A
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application. 
If the applicant lists prior submissions, address the applicable questions 
below:
a. 510(k) #______________________________________
i. If this device has been the subject of an NSE decision, does 
the PMA address any issues relating to safety or 
effectiveness?
b. IDE #_________________________________________
i. Have the data presented in the PMA taken into account any 
safety or effectiveness concerns (e.g., future 
considerations) previously communicated through IDE 
correspondence?
c. PMA #________________________________________
i. If a previously submitted PMA for this device been 
withdrawn, does the current PMA address any issues 
related to safety or effectiveness raised during review of the 
prior PMA?
d. Modular PMA #________________________________
i. If Yes, how many modules submitted? ____________
How many modules were closed? _______________
ii. If there are modules that are on hold, does the PMA address 
outstanding deficiencies?
2. Does the applicant list Q-Submission(s) regarding the device or this 
application in which FDA feedback regarding data or information related 
to safety and/or effectiveness in the PMA was provided by email or during 
29 Contains Nonbinding Recommendations
Inventory of Organizational and Administrative Elements  
(21 CFR 814.20 unless otherwise indicated) 
Check Yes if item is present, N/A if it is not needed and Not Present if it is not included but 
needed. 
    Any Not Present answer will result in a Refuse to Accept decision.  Present  Not 
  Each element on the checklist should be addressed within the    Present 
application. An applicant may provide a rationale for omission for any  (No) 
Yes  N/A 
criteria that are deemed not applicable. If a rationale is provided, the 
criteria is considered Present (Yes). An assessment of the rationale 
will be considered during the review of the application.  
a meeting (in person or by phone), or state that there were no prior Q-  
Submission interactions with the FDA regarding this application?
If the applicant lists Q-Submissions, address the applicable questions 
below: 
    a.  Q-Submission #____________________       
Meeting date(s), if applicable_____________________________ 
    b.  Copy of minutes from each meeting or other written feedback?       
    c.  Were all staff concerns or action items previously presented to the 
applicant in the Q-Submission minutes or feedback addressed in 
the PMA or has the applicant provided a detailed scientific or 
clinical justification for an alternative approach?
30 Contains Nonbinding Recommendations
Acceptance Decision Questions
A No answer will result in an RTA decision.
Yes No
Decision 1 Is the PMA complete?
If, on its face, the PMA is missing one or more required elements 
(identified above), answer No.
Decision 2 From only an administrative review, does the PMA include information 
that appears to constitute valid scientific evidence?
Only answer No if it is clear that the PMA is supported solely by 
information that 21 CFR 860.7 identifies as not constituting valid 
scientific evidence:
 isolated case reports
 random experience
 reports lacking sufficient details to permit scientific evaluation
 unsubstantiated opinions
Comments:
Decision 3
Does the PMA address the key nonclinical and clinical issues identified 
by FDA prior to submission of the PMA application? 
OR 
Has the applicant provided a detailed scientific or clinical justification 
for the alternate approach?
See the guidance document (Acceptance and Filing Review for 
Premarket Approval Applications (PMAs), pages 14-15) for 
interpretation of this criterion.
Decision:  Accept ___    Refuse to Accept ___
If Accept, notify applicant; if Refuse to Accept, notify applicant and include a copy of this 
checklist.
31 Contains Nonbinding Recommendations
Digital Signature Concurrence Table
Reviewer Sign-Off
Team Leader/Assistant 
Director Sign-Off
Division Sign-Off
Only proceed to the Filing Review section if the file is Accepted, indicating that review can 
continue.
32 Contains Nonbinding Recommendations
Checklist for Filing Review for PMAs
Filing Assessment of Technical Elements  Clinical Studies
Check Yes if the information submitted is considered adequate to permit substantive review, N/A if 
it is not needed and No if it is not included.
Present Not 
Present
Yes N/A
(No)
A. Consistency of study data: 1) with the protocol in the approved IDE (if one was required) or with the 
sponsors study protocol for a foreign study (i.e., conducted solely outside of the U.S.); 2) with 
recommendations from a Q-Submission interaction, if applicable; and/or 3) in accordance with a device-
specific guidance document, if applicable.    
1. Sample size/number of patients enrolled and completing the study ( i.e., 
the number of evaluable patients at the primary endpoint timeframe) 
2. Follow-up duration for the primary analysis
3. Follow-up evaluations for the primary analysis
4. Study Objectives
5. Study Population/Enrollment Criteria
6. Study Endpoints
7. Study Design
8. Hypothesis
9. Statistical Analysis
a. Effectiveness 
b. Safety Analyses 
B. Appropriateness of key aspects of the protocol
1. Does the patient/study population match the intended use?
2. Have clinically significant endpoints been selected?
3. If the primary study is based on foreign clinical data, does the applicant 
provide a justification with respect to how the data are applicable to the 
U.S. patient population (e.g., are the population and medical practices 
comparable to those in the U.S., or if not, has a justification been 
provided for why any differences would not impact the applicability of 
33 Contains Nonbinding Recommendations
Filing Assessment of Technical Elements  Clinical Studies 
Check Yes if the information submitted is considered adequate to permit substantive review, N/A if 
it is not needed and No if it is not included.
Present Not 
Present
Yes N/A
(No)
the study results to the U.S. patient population [21 CFR 814.15(a) and 
814.15(b)])? 
 
Filing Decision Questions 
The Filing Decision Questions are shaded and bolded.  Some Filing Decision Questions are 
preceded by introductory questions (denoted by suffixes a and b) to ensure that those 
Filing Decision Questions are answered appropriately. 
    Yes  No 
Decision  Was each study completed and analyzed per the protocol (answers to A1-9     
1a  under Filing Assessment of Technical Elements)? 
  If Yes, answer Yes to Decision 1 below. 
  If No, describe and continue on to Decision 1b. 
Comments: 
 
 
Decision  If any study was not completed per the protocol, did the applicant provide a 
1b  detailed scientific or clinical justification for this alternate approach, without 
the intention of updating the PMA with additional data?
 If Yes, describe and answer Yes to Decision 1 below.
 If No (i.e., no justification is provided, or a clinical update is 
intended), describe and answer No to Decision 1 below.
Comments:
Decision 1 Were the clinical study data collected and analyzed per the protocol?
Decision  Were the studies performed using the final device design (i.e., the device 
2a design intended to be marketed)?
 If Yes, answer Yes to Decision 2 below.
 If No, describe and continue on to Decision 2b.
Comments:
34 Contains Nonbinding Recommendations
Filing Decision Questions 
The Filing Decision Questions are shaded and bolded.  Some Filing Decision Questions are 
preceded by introductory questions (denoted by suffixes a and b) to ensure that those 
Filing Decision Questions are answered appropriately. 
    Yes  No 
Decision  If the studies were performed using an earlier device design, did the     
2b  applicant provide a detailed scientific or clinical justification for why the 
changes made do not impact safety AND effectiveness? 
 If Yes, describe and answer Yes to Decision 2 below. 
 If No (i.e., device changes were made that could impact safety OR 
effectiveness and no justification is provided), describe and answer 
No to Decision 2 below. 
Comments: 
 
 
Decision 2  Were the nonclinical and clinical data collected on the final design of the     
device (i.e., the device design intended to be marketed)? 
 
Decision  Does the patient/study population match the devices indication for use, are 
3a  the endpoints clinically relevant, and, if the pivotal study was conducted 
outside the U.S., does the applicant discuss why the data are adequate to 
support approval in that the foreign data/patient population and medical 
practice are applicable to those of the U.S. (answers to B1-3 under Filing 
Assessment of Technical Elements)?  
 If Yes, answer Yes to Decision 3 below.
 If No, describe and continue on to Decision 3b.
Comments:
Decision  If No to question 3a, did the applicant provide a detailed scientific or 
3b clinical justification?
 If Yes, describe and answer Yes to Decision 3 below.
 If No, describe and answer No to Decision 3 below.
Comments:
Decision 3 Were the patient/study population and endpoints selected 
appropriately?
Decision:  Review Team Recommendation: File___ Not File___
35 Contains Nonbinding Recommendations
Digital Signature Concurrence Table
Reviewer Sign-Off
Team Lead/Assistant 
Director Sign-Off
Division Sign-Off
Office Sign-Off
(for NOFI only)
36