Draft Guidance for Industry and 

FDA Staff 

Annual Reports for Approved 

Premarket Approval Applications 

(PMA) 

DRAFT GUIDANCE 

This guidance document is being distributed for comment purposes only. 

Document issued on: October 26, 2006

Comments and suggestions regarding this draft document should be submitted within 90 days 

of publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit written comments to the Division of Dockets Management (HFA-305), 

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 

Alternatively, electronic comments may be submitted to 

http://www.fda.gov/dockets/ecomments. All comments should be identified with the docket 

number listed in the notice of availability that publishes in the Federal Register. 

For questions regarding this document contact Laura Byrd at 240-276-4040 or 

Laura.Byrd@fda.hhs.gov. For questions regarding the application of this guidance to devices 

regulated by the Center for Biologics Evaluation and Research (CBER), contact Leonard Wilson at 

301-827-0373 or by email at leonard.wilson@fda.hhs.gov. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Devices and Radiological Health 

Center for Biologics Evaluation and Research 
Contains Nonbinding Recommendations 

Draft - Not for Implementation

Preface 

Additional Copies 

Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ode/1585.pdf, 

or to receive this document via your fax machine, call the CDRH Facts-On-Demand system 

at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. 

At the second voice prompt, press 1 to order a document. Enter the document number (1585) 

followed by the pound sign (#). Follow the remaining voice prompts to complete your 

request. 
Contains Nonbinding Recommendations 

Draft - Not for Implementation

Table of Contents 

1. Introduction........................................................................................... 1

2. Background............................................................................................ 3

3. Post-Approval Study Reports.............................................................. 4

4. Contents of an Annual Report............................................................. 4

5. FDA’s Review of Your Annual Report............................................... 8 

6. FDA’s Recommendations..................................................................... 9
Contains Nonbinding Recommendations 

Draft - Not for Implementation

Draft Guidance for Industry and FDA Staff 

Annual Reports for Approved Premarket 

Approval Applications (PMA) 

This draft guidance, when finalized, will represent the Food and Drug Administration's 

(FDA's) current thinking on this topic. It does not create or confer any rights for or on 

any person and does not operate to bind FDA or the public. You can use an alternative 

approach if the approach satisfies the requirements of the applicable statutes and 

regulations. If you want to discuss an alternative approach, contact the FDA staff 

responsible for implementing this guidance. If you cannot identify the appropriate FDA 

staff, call the appropriate number listed on the title page of this guidance. 

1. Introduction 

Devices subject to premarket approval under section 515 of the Federal Food, Drug, and 

Cosmetic Act (the act) are also subject to periodic reports imposed by the PMA approval 

order (21 CFR 814.82(a), 21 CFR 814.84(b)). We typically specify that you submit a report 

one 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. Although this guidance 

addresses “annual reports,” there may be circumstances where FDA specifies more frequent 

periodic reports. We believe this guidance will also be relevant to the more frequent reports. 

This guidance document describes the information required by 21 CFR 814.84(b), additional 

information requirements that may be imposed by approval order under 21 CFR 814.82, and 

our recommendations for the level of detail you should provide in your annual report. It also 

identifies the steps FDA staff generally takes when reviewing annual reports, the resources 

available to assist staff in their reviews, and the actions they may recommend in their 

conclusions. This guidance document is intended to help ensure your annual reports are 

complete and that the actions of CDRH and CBER staff are consistent. 

In our efforts to bring safe and effective products to market as quickly as possible, CDRH 

needs to be able to rely on a variety of postmarket controls that will assure continuing safety 

and effectiveness after a medical device is widely distributed. We believe that data and 

information gathered in the postmarket setting is critical to our continued confidence in the 

1
Contains Nonbinding Recommendations 

Draft - Not for Implementation

safety and effectiveness of the marketed device. Annual reports are one of the important 

tools that FDA relies upon to gather information about the device in its post-approval setting. 

Annual reports currently 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 a way that will be most useful to both the company 

and the FDA. For example, the guidance recommends that you describe in detail the 

rationale for changes made to your device, including whether the changes were the result of 

product complaints and adverse events. This will give us a more complete picture of the 

post-market safety profile of the device. The guidance also recommends that you include a 

summary of all changes that were made to your device during the reporting period, including 

those that were the subject of a PMA supplement. Having the information submitted in this 

way will help ensure that limited agency resources are devoted to assessing meaningful 

information rather than sifting through vast amounts of data that has not been systematically 

reviewed by the firm. 

FDA believes that the types of information that we are requesting in this guidance and the 

types of review, summary, and analysis we are recommending are already part of the quality 

system practices of companies that comply with GMP regulations. For example, design 

controls already require the type of look back and assessment that we are suggesting be part 

of the annual report. 

Annual reports that contain well developed and meaningful information will be an important 

tool for the agency and the industry to assure postmarket safety and protect the public. When 

manufacturers prepare the type of analysis this guidance describes and provide this 

information to FDA in annual reports, industry and FDA will be better positioned to 

recognize and address possible safety signals. 

The Least Burdensome Approach 

This draft guidance document reflects our careful review of what we believe are the relevant 

issues related to annual reports and what we believe would be the least burdensome way of 

addressing these issues. If you have comments on whether there is a less burdensome 

approach, however, please submit your comments as indicated on the cover of this document. 

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 guidances means that 

something is suggested or recommended, but not required. 

2
Contains Nonbinding Recommendations 

Draft - Not for Implementation

2. Background 

In the PMA approval order, FDA requires that PMA sponsors submit post-approval periodic 

reports, i.e., annual reports to FDA, in accordance with 21 CFR 814.82(a)(7) and 814.84(b). 

Section 21 CFR 814.84(b) describes the information required: 

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). 

2. Contain a summary and bibliography of the following information not previously 

submitted as part of the PMA: 

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. 

You are primarily responsible for determining whether changes to your device, labeling, or 

manufacturing processes impact safety or effectiveness and, thus, require a PMA Supplement 

or 30-Day Notice.1 This guidance is not intended to define when you should submit a new 

original PMA or any type of PMA Supplement. 

In accordance with 21 CFR 814.84(a), you must also comply with Medical Device Reporting

(MDR) requirements, 21 CFR Part 803, and any requirements made applicable by other 

regulations or by order approving the device, including: 

• Post Approval Study Reports, if FDA has imposed continuing evaluation (postapproval study) requirements on your device in the PMA approval order, 21 CFR 

814.82(a)(2) 

• Adverse Reaction Reports and Device Defect Reports, if imposed in the PMA 

approval order, 21 CFR 814.82(a)(9), but only to the extent such reports do not 

duplicate MDR reporting requirements. 

 

1

We recommend that you carefully assess whether a change requires a PMA Supplement, 21 

CFR 814.39(a) or 30-Day Notice, 21 CFR 814.39(e). The list of examples in 21 CFR 

814.39(a) illustrates the kind of changes that require a PMA Supplement; however, it is not 

an exhaustive list. 

3
Contains Nonbinding Recommendations 

Draft - Not for Implementation

3. Post-Approval Study Reports 

As provided by 21 CFR 814.82(a)(2), FDA may require continuing evaluation (post-approval 

study) and periodic reporting on the safety, effectiveness, and reliability of your device (postapproval study report), in addition to requiring annual reports under 21 CFR 814.82(a)(7). 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. 

We recommend that you submit your annual report and post-approval study report 

separately, even if they are due at the same time. This will facilitate FDA’s review because 

different Offices in CDRH review the post-approval study report and the annual report.2

 If 

you choose to provide a separate report as recommended, please include the date that you 

submitted your post-approval study report in your annual report. 

If you choose to include your post-approval study report along with your annual report, we 

recommend that you create a separate section of the annual report for the post-approval study 

report. 

4. Contents of an Annual Report 

A complete annual report should include all of the information described below. If your 

annual report is complete, we can review your annual report more efficiently and it is more 

likely that we will not request additional information from you. 

Cover Letter for an Annual Report 

We recommend that you include a cover letter to your PMA annual report. Your cover 

letter should include: 

PMA Number 

Device Name (including any model names and numbers) 

Company Name 

Date of Report 

Reporting Period (i.e., the dates the reporting period begins and ends) 

 

2

See the draft guidance, Procedures for Handling Post-Approval Studies Imposed by 

PMA Order, issued for comment on September 15, 2005 at 

http://www.fda.gov/cdrh/osb/guidance/1561.html. (When final, the internet address will 

link to the guidance issued for implementation.) 

4
Contains Nonbinding Recommendations 

Draft - Not for Implementation

Approval Date (dates original PMA and any PMA Supplements were approved) 

Manufacturing, Design, and Labeling Changes 

To facilitate our review of your annual report, we recommend dividing your report into 

separate sections for manufacturing, design, and labeling changes. 

As described below, each of the three sections should identify all changes made during 

the reporting period3, including those that were submitted in a PMA supplement or 30-

Day Notice and those changes that you have not already reported in a PMA Supplement 

or 30-Day Notice.4

 

Identification of the Changes 

For each change in your summary, we recommend you identify: 

• the change made; 

• the rationale for making the change; 

• a listing of any validation or other testing that was performed, including a 

description of the method and acceptance criteria (but not the data itself); and 

• the implementation date. 

For changes that are the subject of an approved or pending PMA Supplement or 30-Day 

Notice, we recommend that you also identify the document number assigned by FDA 

and, if approved, the approval date. 

We recommend that you provide separate tables for manufacturing changes, design 

changes, and labeling changes. An example of a design changes table is provided below. 

We recommend that you include similar tables for manufacturing changes and labeling 

changes. 

Design Changes Table 

 

3

 Please note that simple changes related to the device documentation or manufacturing 

process documentation, such as rewording or expanding for clarification, translating from 

one language to another, correcting typographical errors, and moving component 

characteristics from an engineering drawing note to a different document, such as an SOP, do 

not need to be reported in the annual report. In general, such changes do not affect the 

design, performance, labeling or processing of the device, only how the characteristics are 

documented. 

4

 In accordance with 21 CFR 814.39(b), you may change your approved device without 

submitting a PMA Supplement, if the change does not affect the device’s safety or 

effectiveness and you report the change to FDA in your annual report. 

5
Contains Nonbinding Recommendations 

Draft - Not for Implementation

Change Rationale 

for Change 

Summary of 

Validation 

Activities 

Implementation 

Date 

PMA 

Supplement 

Type & Number 

Assigned by 

FDA, if 

applicable 

Approval 

Date, if 

applicable 

Examples of rationales for device changes we recommend you specify include whether 

the change was: 

• made as a result of a problem that resulted in an MDR (if so, we recommend that 

you provide the applicable MDR number(s)); 

• made as a result of an adverse event, device defect, or failure reported to you or 

identified in the literature; 

• associated with any recall or corrective action (see also 21 CFR 820.100); 

• in response to any customer complaint, request, or suggestion; 

• related to any public disclosure or communication on your part, i.e., “Dear 

Doctor” or “Dear Patient” letters or Technical bulletins; 

• related to an FDA Safety Alert, Public Health Notification or warning letter. 

If any change that you have made is associated with any written communications to 

practitioners or patients, we recommend you include a copy of the communication in 

your annual report. 

Detailed Description of Changes Not Reported in Existing Supplements 

For changes not reported in a PMA Supplement or a 30-Day Notice, we recommend that 

you describe the changes and the scientific and/or regulatory rationale basis for 

concluding that the change had no impact on safety or effectiveness. The description and 

rationale should provide sufficient detail to allow FDA to determine that the changes did 

not require a PMA Supplement or 30-Day Notice. It may be helpful to link together the 

summary data in the Tables with the detailed data by some means such as unique 

enumeration. That is, you may wish to number the items in the Tables and then refer to 

those numbers in the detailed descriptions. 

As part of your rationale for the changes you are reporting, we also recommend that you 

include a brief summary of the risk analysis performed to assess the effect of the changes 

6
Contains Nonbinding Recommendations 

Draft - Not for Implementation

made during the reporting period that were not already described in PMA supplements or 

30-Day Notices. If you did not conduct system-level testing of the cumulative changes, 

your risk analysis should also assess whether incremental testing was adequate to assure 

continued safety and effectiveness of your device in the absence of system level testing. 

If you performed the risk analysis in conformance to any consensus standards, these 

should be identified. 

If any changes to the design, manufacturing, or labeling you have made during the 

reporting period (that did not require submission of a PMA supplement or 30 Day notice) 

are associated with MDRs, failures or recalls of any kind, corrective actions (21 CFR 

820.100), complaints, or in response to FDA warning letters or inspection findings 

(“FDA Form 483”), we recommend you: 

• describe your investigation of the cause or source of the problem 

• explain your decision to change your device design, labeling or manufacturing 

process by describing how the changes have corrected the problem and mitigated 

harm5

Summary and Bibliography of Reports of Scientific Investigations and 

Literature 

You are required to provide a summary and bibliography of reports in the scientific 

literature that are known, or that reasonably should be known to you, and that were not 

previously submitted as part of your PMA application (21 CFR 814.84(b)(2)(ii)). If there 

are reports or scientific literature on clinical or nonclinical studies of similar devices, we 

recommend that you include them in your summary and bibliography. 

The summary and bibliography must also include unpublished reports of data from any 

clinical investigations or nonclinical laboratory studies involving your device or related 

devices that are known, or that reasonably should be known to you (21 CFR 

814.84(b)(2)(i)). 

Your 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 your 

device. If, as a result of reviewing the reports and literature, you determine that changes 

to your device or its labeling are necessary, we recommend that you inform us of your 

plan for submitting a PMA supplement or 30-Day Notice for these changes or explain 

why you believe such a submission is not appropriate. 

 

5

 Please note, any information supplied in this report related to corrective actions will be 

evaluated with the purpose of understanding the reason for the change to your device design, 

labeling or manufacturing process. The information will not be evaluated for adequacy with 

respect to compliance with 21 CFR 820.100. 

7
Contains Nonbinding Recommendations 

Draft - Not for Implementation

If, after reviewing your annual report, we conclude that we need an actual copy of a 

published or unpublished report, we will notify you. You must submit a copy in 

response, as required by 21 CFR 814.84(b)(2)(ii). However, if you anticipate that we 

will need a copy of any of these reports, you may, on your own initiative, provide it in 

your annual report. 

Information on Devices Shipped or Sold 

To help FDA assess the public health impact of the previously requested information, we 

are also asking that you provide us with 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. 

Posting of Reports and Option to Submit a Redacted Copy 

The confidentiality of information in a PMA file, which includes information in annual 

reports, is governed by 21 CFR § 814.9. Consistent with this regulation and with 21 CFR 

Part 20, we intend to publicly post a redacted copy of your annual report on our website. 

FDA will not make public any confidential commercial or financial information or trade 

secrets6

 or any information the disclosure of which might cause an unwarranted invasion 

of personal privacy.7 You may, on your own initiative, include a redacted copy of your 

annual report for this purpose. 

5. FDA’s Review of Your Annual Report 

FDA's review of annual reports will allow the agency to assess several important issues 

related to post-market safety of approved devices. These issues include the nature and 

adequacy of reported modifications and the adequacy of report documentation. If, after 

reviewing your annual report, we need additional information, or if we believe the device 

modifications you have reported require a PMA Supplement or a 30-Day Notice, we will 

notify you in writing. 

Several FDA offices may work in partnership in reviewing your annual report. In CDRH, 

the Office of Device Evaluation (ODE) or the Office of In Vitro Diagnostics (OIVD), 

 

6 See 21 CFR 20.61. 

7

 See, for example, 21 C.F.R. 20.63(a), “The names or other information which would 

identify patients or research subjects in any medical or similar report, test, study or other 

research project shall be deleted before the record is made available for public disclosure.”

8
Contains Nonbinding Recommendations 

Draft - Not for Implementation

depending on the device type, has the primary responsibility for reviewing the scientific 

information, including design and labeling changes. Generally, The Office of Compliance 

(OC) and ODE or OIVD review the manufacturing information. As necessary, the Office of 

Surveillance and Biometrics (OSB) may also perform a search of the MAUDE database to 

further evaluate MDRs submitted during the reporting period. The review memo will 

include the findings from each Office. 

FDA intends to review most annual reports within 90 days of receipt. In general, our review 

memos follow the format described below. 

Reported Changes and Rationale for the Changes 

Our review memo will summarize the changes described in the annual report and our 

evaluation of those changes. Our review memo will also describe our understanding of 

your rationale for the changes and our assessment of your rationale. The memo will 

clearly indicate whether we believe the changes you described are appropriate for an 

annual report or should have been described in a PMA Supplement or a 30-Day Notice. 

Device Change Information 

ODE or OIVD, in consultation with other Offices within CDRH, as appropriate, will 

evaluate your summary of the changes made to your device. As appropriate, we also plan 

to search the MAUDE database and review other FDA records to assess the post-market 

safety profile of your device.

We will evaluate the information on the changes made to the device and the rationale for 

the changes, along with information you submitted from published and unpublished 

reports, and literature to determine if the safety and effectiveness profile of your device 

has changed. We can then determine whether any action (e.g., labeling change) is 

necessary to ensure the continued safety and effectiveness of your device. 

6. FDA’s Recommendations 

Generally, our review memo will conclude with one of the following recommendations 

described below. 

Acknowledgement of Complete Annual Report 

If we determine that the annual report fulfills the requirements of 21 CFR 814.84, we will 

issue a letter or send an e-mail to inform you that the annual report is complete. 

Request Additional Information 

If you have not provided all the information required for an annual report, or we find that 

the information provided is not sufficient to allow a complete review, we plan to request 

9
Contains Nonbinding Recommendations 

Draft - Not for Implementation

additional information by letter or e-mail. If we only need clarification of an issue, we 

will either telephone or email you, whichever we believe will be the most expeditious. 

Changes Not Appropriate for an Annual Report 

If we determine that a change made to the device required a PMA Supplement or 30-Day 

Notice under 21 CFR 814.39, and you did not meet this requirement, we will notify you 

in writing. In general, we will issue a letter notifying you that a PMA Supplement or 30-

Day Notice is required for the change and requesting that you provide the appropriate 

submission within a specified timeframe. However, there may also be instances when 

OC will review to determine if any additional regulatory actions are warranted. 

10