Contains Nonbinding Recommendations 
 
Annual Reports for Approved 
Premarket Approval Applications 
(PMA) 
 
Guidance for Industry and Food 
   and Drug Administration Staff    
 
 
 
Document issued on December 16, 2019. 
 
Document originally issued on February 10, 2014.    
 
 
 
For questions regarding the use or interpretation of this guidance document in the review of annual 
reports for premarket approval applications (PMA), please contact ORP:  Office of Regulatory 
Programs/Division of Regulatory Programs 1: Submission Support at 301-796-5640.   
 
For questions regarding the application of this guidance to devices regulated by the Center for 
Biologics Evaluation and Research (CBER), contact CBERs 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 http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), 
Rockville, MD 20852.  Identify all comments with the docket number FDA-2006-D-0039. 
Comments may not be acted upon by the Agency until the document is next revised or 
updated. 
 
Additional Copies 
 
CDRH 
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 1585 and complete title of the guidance in the request. 
 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research 
(CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New 
Hampshire Ave., 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.    Contains Nonbinding Recommendations 
 
 
 
 
Table of Contents 
 
I.  Introduction ............................................................................................. 1 
II.  Background .............................................................................................. 2 
III.  Scope ......................................................................................................... 3 
IV.  Contents of an Annual Report ............................................................... 4 
VI.  FDAs Recommendations ....................................................................... 7 
VII. Other Reports - Post-Approval Study Reports .................................... 8 
    Contains Nonbinding Recommendations 
 
 
 
 
Annual Reports for Approved 
Premarket Approval 
Applications (PMA) 
 
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.  Introduction 
 
Devices subject to premarket approval (PMA) under section 515 of the Federal Food, Drug, and 
Cosmetic Act (the Act) are subject to periodic reporting requirements set forth in the PMA 
approval order (21 CFR 814.82(a), 21 CFR 814.84(b)). This guidance document describes the 
information required to be submitted in annual reports under 21 CFR 814.84(b), additional 
information requirements that may be imposed by approval order under 21 CFR 814.82(a), and 
FDAs recommendations for the level of detail the applicant should provide in the annual report.  
It also identifies the steps FDA staff generally take when reviewing annual reports, the resources 
available to assist staff in their reviews, and the actions they may recommend after reviewing 
annual reports.  This guidance document is intended to help ensure that annual reports are 
complete and that the actions of CDRH and CBER staff are consistent. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
  1    Contains Nonbinding Recommendations 
 
 
 
II.  Background 
 
A.  General Background 
 
FDA needs to be able to rely on a variety of postmarket controls to assure the continuing 
safety and effectiveness of a medical device after it is distributed. FDA believes that data and 
information gathered in the postmarket setting are critical to our continued confidence in the 
safety and effectiveness of the marketed device.  Annual reports are one of the important tools 
that FDA relies on to gather information about the device in its post-approval setting. 
 
Annual reports contain a variety of information, including information about manufacturing 
changes, design changes, and labeling changes that were made during the preceding year for 
the PMA product. This guidance recommends that this and other information be analyzed and 
presented in annual reports in a way that will be most useful to both the applicant and FDA.  
For example, the guidance recommends that the applicant describe in detail the rationale for 
changes made to the device, including, for example, whether the changes were the result of 
device improvement/enhancement, product complaints, or adverse events.  This explanation 
will give FDA a more complete picture of the post-market safety profile of the device.  The 
guidance also recommends that the applicant include a summary of all changes that were 
made to the device during the reporting period, including listing all supplements submitted 
during the reporting period and, if approved, their approval date. Having the information 
submitted in this way will help ensure that limited Agency resources are devoted to assessing 
meaningful information rather than requiring FDA to sift through vast amounts of data that 
have not been systematically reviewed by the firm. 
 
Annual reports that contain clear descriptions and meaningful information are an important 
tool for the Agency and the industry to assure postmarket safety and protect the public.  
When applicants prepare and provide to FDA in annual reports the type of analysis this 
guidance describes, industry and FDA are better positioned to recognize and address possible 
safety issues. 
 
B.  Regulatory Background 
 
In PMA approval orders, FDA requires that PMA applicants submit post-approval periodic 
reports (e.g., annual reports at intervals of 1 year (unless otherwise specified) from the date 
of approval of the original PMA) to FDA in accordance with 21 CFR 814.82(a)(7) and 
814.84(b).  Section 814.84(b) describes the information required to be included in periodic 
reports. 
 
Unless FDA specifies otherwise, a periodic report must: 
 
1.  Identify changes described in 21 CFR 814.39(a) and changes required to be 
reported to FDA under 21 CFR 814.39(b); and 
 
2.  Contain a summary and bibliography of the following information not previously 
submitted as part of the PMA: 
  2    Contains Nonbinding Recommendations 
 
 
 
i.  Unpublished reports of data from any clinical investigations or nonclinical 
laboratory studies involving the device or related devices and known to or that 
reasonably should be known to the applicant. 
 
ii.  Reports in the scientific literature concerning the device and known to or that 
reasonably should be known to the applicant. 
 
If, after reviewing the summary and bibliography, FDA concludes that the Agency 
needs a copy of the unpublished or published reports, FDA will notify the applicant 
that copies of such reports shall be submitted. 
 
The PMA applicant is primarily responsible for determining whether changes to the device 
design, labeling, or manufacturing processes impact safety or effectiveness and, thus, require a 
PMA Supplement or 30-Day Notice.  This guidance is not intended to define when a PMA 
applicant should submit a new original PMA or any type of PMA Supplement. For that type 
of guidance, please refer to the FDA guidance, Modifications to Devices Subject to 
Premarket Approval (PMA)  The PMA Supplement Decision-Making Process.1   
 
PMA applicants are also subject to other reporting requirements.  In accordance with 21 CFR 
814.84(a), the applicant must comply with Medical Device Reporting (MDR) requirements, 
21 CFR Part 803, and any applicable requirements in other regulations or by order approving 
the device, including Post-Approval Study Reports if FDA has imposed continuing evaluation 
(post-approval study) requirements on the device in the PMA approval order, 21 CFR 
814.82(a)(2). 
 
FDA believes that the types of information described in this guidance and the types of review, 
summary, and analyses we are recommending should be readily available to applicants 
because they currently collect this information and conduct these analyses as part of their 
compliance with the quality system regulations (21 CFR Part 820). For example, design 
controls already require the type of look back and assessment that we are suggesting be part 
of the annual report (21 CFR 820.30). 
 
III. Scope 
 
In the PMA approval orders, we typically specify that PMA applicants submit a report one (1) 
year from the date of approval of the original PMA and annually thereafter. Therefore, the 
periodic report is usually referred to as an annual report.  There may be circumstances, 
however, where FDA specifies more frequent periodic reports that provide all of the same 
information that is reported annually.  This guidance addresses FDAs expectations concerning 
annual and other periodic reports.  This guidance addresses but does not describe in detail Post-
Approval Study reports (see Section VI). 
 
                                                           
1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-
premarket-approval-pma-pma-supplement-decision-making-process  
  3    Contains Nonbinding Recommendations 
 
 
IV.  Contents of an Annual Report 
2 
A complete annual report (in an acceptable eCopy format) should include all of the 
information described below. The eCopy must be accompanied by a single paper copy of your 
signed cover letter. 
 
Cover Letter for an Annual Report 
 
FDA recommends that the applicant include a cover letter for the PMA annual report. The 
cover letter should include: 
 
  PMA Number 
  Device Name (including device family name or model names and numbers)  
  Company Name 
  Date of Report 
  Reporting Period (i.e., the dates the reporting period begins and ends) 
 
Identification of the Changes Made During the Reporting Period 
 
For changes that are the subject of an approved or pending PMA Supplement or 30-Day 
Notice submitted in the reporting year, we recommend that the applicant identify the 
document number assigned by FDA and status of the document (e.g., approved with approval 
date, or pending). 
 
Certain changes related to the device documentation or manufacturing process documentation, 
such as rewording for clarification, translating from one language to another, correcting 
typographical errors, and moving component characteristics from a notation in an engineering 
drawing to a different document, such as an Standard Operating Procedure, generally do not 
need to be reported in the annual report (21 CFR 814.39(b)).  In general, such changes do not 
affect the design, performance, labeling, or processing of the device, and affect only how the 
characteristics are documented.  These types of changes have been commonly referred to as 
document to file by industry and should be kept in your design history file. 
 
For each change that was identified as an annual reportable change that did not require a PMA 
Supplement or 30-Day Notice under 21 CFR 814.39(b), we recommend you identify the 
following, as applicable: 
 
  description of the change made, including a comparison to the previously approved 
version; 
 
  rationale for making the change, including identification of event(s) related to the 
rationale/reason for the change (e.g., MDR number(s), recall number); 
 
  listing/grouping of associated changes that were made to address the same issue; and 
                                                           
2 Please refer to the FDA guidance, eCopy Program for Medical Device Submissions 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions), for additional information on the eCopy program. 
  4    Contains Nonbinding Recommendations 
 
 
 
  scientific and/or regulatory basis for concluding that the change had no impact on safety 
or effectiveness in order to allow FDA to understand how the applicant determined the 
change did not require a PMA Supplement or 30-Day Notice. 
 
FDA recommends that the applicant provide separate tables for manufacturing changes, design 
changes, and labeling changes, and that the applicant identify changes that are associated with 
each other so it is clear which changes are linked.  For example, certain changes might be 
linked to each other because they are intended to improve or correct the same aspect of the 
device.  See below for the recommended format for the Changes Tables. 
 
 
Design [or Manufacturing or Labeling] Changes Table 
Change  Type of Change  Description  Rationale for Change  Related  Why 
Order  (design,  of Change  (including  Changes  Change 
Number  labeling,  identification of  Does Not 
or  manufacturing)  event(s)  Impact 
unique  linked/leading to  S&E* 
way to  reason for change) 
identify 
change 
           
* Verification and Validation data should not be submitted by an applicant in an 
annual report (or reviewed by FDA in a report). 
 
Below are examples of rationales for device changes.  FDA recommends the applicant specify 
all of the relevant reasons that apply to the change, including but not limited to those we have 
listed here, as this list is not exhaustive of all possible reasons for making device changes: 
 
  made as a result of a device improvement or enhancement; 
 
  made as a result of an adverse event, device defect, or failure reported to the applicant or 
identified in the literature (if the event resulted in an MDR, FDA recommends that the 
applicant provide the applicable MDR number(s)); 
 
  made in response to a customer complaint, request, or suggestion; 
 
  made in association with any recall or corrective action, see also 21 CFR 820.100 (FDA 
recommends that the applicant list the recall number or identify if considered a class III 
recall); 
 
  5    Contains Nonbinding Recommendations 
 
 
  related to an FDA Safety Alert, Public Health Notification, or warning letter; 
 
  related to any public disclosure or communication on the applicants part (e.g., Dear 
Doctor or Dear Patient letters, Technical Bulletins, or other written communication to 
practitioners, patients, or sales staff).  FDA recommends that the applicant include a copy 
of the communication in the annual report. 
 
Summary and Bibliography of Reports of Scientific Investigations and 
Literature 
 
The applicant is required to provide a summary and bibliography of reports in the scientific 
literature concerning the device that are known, or that reasonably should be known to the 
applicant, and that were not previously submitted as part of the PMA application (21 CFR 
814.84(b)(2)(ii)). The summary must also include unpublished reports of data from any 
clinical investigations or nonclinical laboratory studies involving the device or related devices 
that are known or that reasonably should be known to the applicant (21 CFR 814.84(b)(2)(i)). 
 
The summary should include a discussion of how the results and conclusions in the reports 
and literature could impact the known safety and effectiveness profile of the device as well as 
a description of your plans for assessing the potential impact.  If after reviewing the literature, 
no issues are identified regarding safety and effectiveness, please clearly state this in the 
annual report. 
 
If, after reviewing your annual report, FDA concludes that we need an actual copy of a 
published or unpublished report, FDA will notify the applicant, who must submit a copy in 
response, as required by 21 CFR 814.84(b)(2)(ii).  However, if the applicant anticipates that 
FDA will need a copy of any of these reports, applicants may provide a copy in the annual 
report on their own initiative. 
 
Information on Devices Shipped or Sold 
 
To help FDA assess the public health impact of the previously requested information, FDA has 
required in approval orders issued after August 1, 2009 that the applicant provide FDA with 
3   
data about the number of devices shipped or sold during the reporting period. For device 
implants, data regarding the number of devices actually implanted should be provided, if it is 
available. 
 
V.  FDAs Review of Annual Reports 
 
FDAs review of annual reports allows the Agency to assess several important issues related 
to postmarket safety and effectiveness of approved devices. These issues include the nature 
and adequacy of reported modifications and the adequacy of report documentation.  If, after 
reviewing the annual report, FDA needs additional information, or if we believe the device 
modifications that the applicant has reported require a PMA Supplement or a 30-Day Notice, 
                                                           
3 As provided in 21 CFR 814.82(a)(9), FDA may find this information to be necessary to provide a continued 
reasonable assurance of the safety and effectiveness of the device.   
  6    Contains Nonbinding Recommendations 
 
 
FDA will notify the applicant via letter or email.4   
 
FDA reviews most annual reports within 90 days of receipt.  In general, our review 
memoranda follow the format described below. 
 
Reported Changes and Rationale for the Changes 
 
FDAs review memorandum will summarize the changes described in the annual report and 
our evaluation of those changes.  The review memorandum will also describe FDAs 
understanding of the applicants rationale for the changes and our assessment of the rationale.  
The memorandum will clearly indicate whether FDA believes the changes described by the 
applicant are appropriate for an annual report or should have been described in a PMA 
Supplement or a 30-Day Notice.
 
 
Device Change and Bibliography Information 
 
FDA will evaluate your summary of the changes made to the device. As appropriate, FDA 
also plans to search the MAUDE database and review certain other FDA records to assess the 
post-market safety profile of your device. 
 
FDA will evaluate the information on the changes made to the device and the rationale for 
the changes, as well as the information the applicant submits from published and 
unpublished reports, and literature to determine if any of this information demonstrates that 
the safety and effectiveness profile of the device has changed.  FDA can then determine 
whether any action (e.g., a labeling change) is necessary to ensure the continued safety and 
effectiveness of the device. 
 
VI. FDAs Recommendations 
 
Generally, FDAs review will result in one of the following recommendations: 
 
Acknowledgement of Review of Annual Report 
 
When FDA reviews the annual report and has no further questions, we will issue a letter or 
send an e-mail to inform the applicant of this status and indicate that no additional 
information is needed. 
 
Request Additional Information 
 
If the applicant has not provided all the information required for an annual report, or FDA 
finds that the information provided is not sufficient to allow a complete review, we will 
request additional information by letter or email.  If FDA needs only clarification of an issue, 
we will work interactively with the applicant via telephone or e-mail, whichever FDA 
believes will be the most efficient. 
 
Changes Not Appropriate for an Annual Report 
 
If FDA determines that a change made to the device required a PMA Supplement or 30- Day 
                                                           
4 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. 
  7    Contains Nonbinding Recommendations 
 
 
Notice under 21 CFR 814.39, and one was not submitted, we will notify the applicant   by 
letter or email.4  In general, FDA will issue a letter notifying the applicant that a PMA 
Supplement or 30-Day Notice is required for the change and request that the appropriate 
submission be provided within a specified timeframe. However, there may also be instances 
when OC review is necessary to determine if any additional regulatory actions are warranted. 
 
VII. Other Reports - Post-Approval Study Reports 
 
As described in 21 CFR 814.82(a)(2), FDA may require continuing evaluation (post- 
approval studies) and periodic reporting on the safety, effectiveness, and reliability of the 
device for its intended use (post-approval study reports). If your approval order identifies 
post-approval studies you must conduct, the order will describe the purpose of the studies 
and how frequently you must submit post-approval study reports. 
 
Please submit your annual report and post-approval study report separately, even if they are 
due at the same time, and identify the date that you submitted your post-approval study 
report in your annual report.  This will facilitate FDAs review because the post-approval 
study report and the annual report are typically reviewed for different purposes.5  
 
                                                           
5 See the guidance, Procedures for Handling Post-Approval Studies Imposed by PMA Order, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-handling-post-
approval-studies-imposed-pma-order. 
 
  8