Contains Nonbinding Recommendations 
 
 
 
Postmarket Surveillance Under 
Section 522 of the Federal Food, Drug, 
and Cosmetic Act 
 
Guidance for Industry and  
Food and Drug Administration Staff 
 
Document issued October 7, 2022. 
 
The draft of this document was issued on May 27, 2021. 
   
This document supersedes Postmarket Surveillance Under Section 522 of the 
Federal Food, Drug, and Cosmetic Act, issued on May 16, 2016. 
 
For questions about this document, contact OPEQ: Office of Product Evaluation and Quality / 
OCEA: Office of Clinical Evidence and Analysis / Division of Clinical Science and Quality via 
email at MandatedStudiesPrograms@fda.hhs.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   
     
  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-2011-D-0514. 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 19042 and complete title of the guidance in the request.
2 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
I.  Introduction ......................................................................................................................... 4 
II.  Pre-522 Postmarket Surveillance Process ........................................................................ 5 
A. Legal Background ............................................................................................................ 5 
B. Identification of Issue ....................................................................................................... 6 
C. Team Review of Issue ...................................................................................................... 6 
D. Considerations Regarding Pediatric Population Provisions ............................................. 7 
E. Issuance of 522 Order ...................................................................................................... 8 
III. Postmarket Surveillance Plans .......................................................................................... 9 
A. General Information ......................................................................................................... 9 
B. Elements to Include in a Postmarket Surveillance Plan ................................................... 9 
C. FDA and Manufacturer Agreement on Surveillance Plan ............................................. 11 
D. Changes to an Approved Postmarket Surveillance Plan ................................................ 13 
E. Types of Postmarket Surveillance .................................................................................. 14 
IV. When and How to Submit Postmarket Surveillance Reports ....................................... 16 
V.  Content and Format of Postmarket Surveillance Reports ............................................ 17 
A. General Information ....................................................................................................... 17 
B. Postmarket Surveillance Enrollment Reports ................................................................ 18 
C. Interim Postmarket Surveillance Status Report ............................................................. 19 
D. Final Postmarket Surveillance Reports .......................................................................... 20 
VI. Evaluation of Interim Postmarket Surveillance Reports .............................................. 20 
VII.  Evaluation of Postmarket Surveillance Final Reports and Possible FDA Actions 
After 522 Order Completion ............................................................................................ 21 
VIII.  Manufacturers Reporting Status ........................................................................... 22 
IX. Postmarket Surveillance Status ....................................................................................... 23 
X.  Failure to Comply with Postmarket Surveillance Requirements under Section 522 of 
the FD&C Act .................................................................................................................... 25 
XI. Public Disclosure of Postmarket Surveillance Plan Information and Reports ........... 26 
A. FDA Website .................................................................................................................. 26 
APPENDIX 1: Section 522 Administrative Checklist Review (Per 21 CFR 822.9 & 
822.10) ................................................................................................................................ 29 
3 
  Contains Nonbinding Recommendations 
 
 
Postmarket Surveillance Under 
Section 522 of the Federal Food, Drug, 
and Cosmetic Act 
 
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 
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and 
Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket 
surveillance at the time of approval or clearance or at any time thereafter of certain class II or 
class III devices. Postmarket surveillance is the active, systematic, scientifically valid 
collection, analysis, and interpretation of data or other information about a marketed device.1 
The data collected under a surveillance order help to address important public health questions 
on the safety and effectiveness of a device.  
  
This guidance document will assist manufacturers of devices subject to section 522 
postmarket surveillance orders (522 orders) by providing: 
  an overview of section 522 of the FD&C Act; 
  information on how to fulfill section 522 obligations,2 including: 
  when postmarket surveillance should be considered commenced; 
o
  recommendations for achieving an approved postmarket surveillance plan in a 
o
timely manner; and 
  recommendations for enrollment schedules to help achieve timely completion 
o
of postmarket surveillance;  
 
1 21 CFR 822.3(i).  
2 See 21 CFR Part 822 for the full set of procedures and requirements for postmarket surveillance under section 522 
of the FD&C Act.  
4 
  Contains Nonbinding Recommendations 
 
 
  recommendations on the format, content, and review of postmarket surveillance plan 
and report submissions, including revised FDA review times for postmarket 
surveillance-related submissions; and 
  updated surveillance status categories to better reflect progress.  
 
This guidance document also aims to increase transparency to stakeholders on FDAs 
approach to the issuance and tracking of 522 orders, and expectations for timely study 
completion. Our initiative to increase transparency includes posting the manufacturers 
progress on addressing 522 orders on FDAs website.3  
 
In general, FDAs guidance documents 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 guidance means that something is suggested or 
recommended, but not required.  
 
II.  Pre-522 Postmarket Surveillance Process 
 
 
When FDA identifies a potential issue with a device that could warrant postmarket 
surveillance (such as those described in Section II.B below), the associated review team may 
assess whether a 522 order is appropriate and falls within the statutory criteria.  
 
Section 522 of the FD&C Act, 21 U.S.C.  360l, authorizes FDA to require postmarket 
surveillance in the following instances: 
 
  a class II or class III device for which failure of the device would be reasonably likely 
to have a serious adverse health consequence (section 522(a)(1)(A)(i) of the FD&C 
Act); 
 
  a class II or class III device expected to have significant use in pediatric populations 
(section 522(a)(1)(A)(ii) of the FD&C Act); 
 
  a class II or class III device that is intended to be implanted in the human body for more 
than one year (section 522(a)(1)(A)(iii)(I) of the FD&C Act); or 
 
  a class II or class III device that is intended to be a life-sustaining or life-supporting 
device used outside of a device user facility (section 522(a)(1)(A)(iii)(II) of the FD&C 
Act). 
 
 
 
3522 Postmarket Surveillance Studies Database webpage: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm. 
5 
  Contains Nonbinding Recommendations 
 
 
 
FDA may identify device issues that are appropriate for postmarket surveillance at any point 
during the life cycle of a class II or III device, which meets statutory criteria identified in 
section 522(a)(1)(A) of the FD&C Act. Such issues may be identified through a variety of 
sources including analysis of adverse event reports, a recall or corrective action, post-approval 
data, review of premarket data, reports from other governmental authorities, or review of 
scientific literature. 
 
Examples of situations that may raise postmarket questions, during both the premarket and 
postmarket periods, are listed below. FDA may order postmarket surveillance to: 
 
  better understand the nature, severity, or frequency of suspected problems reported in 
adverse event reports or in the published literature. 
 
  obtain more information on device performance associated with real-world clinical 
practice. 
 
  address long term or infrequent safety and effectiveness issues for implantable and 
other devices for which the premarket testing provided more limited information. For 
example, premarket evaluation of a device may have been based on surrogate markers. 
Once the device is actually marketed, postmarket surveillance may be appropriate to 
assess the effectiveness of the device in detecting or treating the disease or condition, 
rather than the surrogate. Data collected through postmarket surveillance may include 
rates of malfunction or failure of a device intended for long-term use or incidents of 
latent sequelae resulting from device use. 
 
  better define the association between problems and devices when unexpected or 
unexplained serious adverse events occur after a device is marketed, if there is a change 
in the nature of serious adverse events (e.g., severity), or if there is an increase in the 
frequency of serious adverse events. 
 
In assessing the appropriateness of issuing a 522 order, multiple elements are considered, as 
indicated below, with the goal of making a determination as to whether or not postmarket 
surveillance for a class II or class III device should be ordered. In addition, FDA may also 
engage external stakeholders prior to the issuance of a 522 order, when appropriate. 
 
Some of the elements considered by FDA in deciding whether to issue a 522 order include: 
 
  Are the statutory criteria of section 522 of the FD&C Act met? 
 
  What is the public health question? The delineation of the public health question is the 
most important element discussed by the team. 
 
  What is the public health question based on? It should be based on FDAs evaluation of 
6 
  Contains Nonbinding Recommendations 
 
 
currently available data. Examples include but are not limited to scientific/medical 
concern from the review of a premarket submission and/or observed issues from the 
premarket data, a recall, medical device reports (MDRs), case studies, literature, or 
another source. 
 
  Is the public health issue device-specific or device type-specific? 
 
  For a device for which a condition of clearance or approval is being considered, can and 
should the public health question be addressed premarket rather than as part of a 522 
order? 
 
  Is there any other source of data (e.g., MDR review, published literature, real-world 
data (RWD) sources) or action (e.g., revised labeling, public health notice, recall), or a 
combination thereof, that may be used to address the public health question, instead of a 
522 order? 
 
  Does another ongoing study (e.g., premarket approval application (PMA) post-approval 
study as described in 21 CFR 814.82(a)(2) and 21 CFR 814.82(a)(9)) address the public 
health question? 
 
  What type(s) of 522 postmarket surveillance design(s) should be recommended? 
Feasibility and timeliness of the different types of postmarket surveillance should be 
considered. 
 
  What combination of efforts should be considered to address the public health question? 
In addition, when applicable, what changes, if any, are being made with regard to the 
premarket review? 
 
As noted above, the statute authorizes postmarket surveillance for class II and III devices that 
are expected to have a significant use in pediatric populations and also authorizes the 
Agency to order postmarket surveillance as a condition of clearance or approval for devices 
expected to have significant use in pediatric populations.4,5 These provisions are not limited to 
devices labeled for pediatric uses, and therefore specific consideration is given to devices with 
anticipated pediatric use. 
 
Note that section 402(j)(1)(A)(ii) of the Public Health Service Act (PHS Act) (42 U.S.C.  
282(j)(1)(A)(ii)) also states that any pediatric postmarket surveillance required under section 
 
4 Sections 522(a)(1)(A)(ii) and 522(a)(1)(B) 
5 Since pediatric populations is not defined in section 522 of the FD&C Act, for the purposes of 522 orders, FDA 
interprets pediatric populations to mean patients who are 21 years of age or younger at the time of diagnosis or 
treatment, that is, from birth through the twenty-first year of life, up to, but not including the patients twenty-second 
birthday. This definition is consistent with the definition of pediatric patients under section 520(m)(6)(E)(i) of the 
FD&C Act, which was added to the FD&C Act at the same time as the pediatric use criterion in section 522. 
7 
  Contains Nonbinding Recommendations 
 
 
522 is considered to be an applicable device clinical trial. As such, the pediatric postmarket 
surveillance must be in compliance with the registration and results submission requirements 
of section 402(j) of the PHS Act (42 U.S.C.  282(j)). Additional information on these 
requirements can be found at https://clinicaltrials.gov/. 
 
FDA intends to work with the manufacturer to help FDA determine the appropriate timeframe 
for a pediatric 522 postmarket surveillance study.              
 
The 522 order will specify the device(s) subject to the surveillance order and the reason that 
we are requiring postmarket surveillance (i.e., the public health question(s)).6 The order will 
also typically include any general or specific guidance that is available to assist the 
manufacturer subject to the 522 order in preparing the postmarket surveillance plan.7 FDA 
intends to identify the premarket submission involved (i.e., premarket notification [510(k)], 
PMA, humanitarian device exemption (HDE) application, or De Novo request) in the 522 
order. A 522 order could also include timelines for certain surveillance plan milestones such 
as subject enrollment, data accrual, and submission of the final report, depending on the plan 
and timing of the order. If a manufacturer disagrees with any order or condition requiring 
postmarket surveillance under section 522 of the FD&C Act, a manufacturer may request 
review under section 562 of the FD&C Act (see section 522(c) of the FD&C Act) and other 
options are further described in 21 CFR 822.7. 
 
Section 522(a)(1)(A) of the FD&C Act specifies that the Agency may issue a postmarket 
surveillance order at the time of device approval or clearance or any time thereafter. When a 
522 order is being considered for issuance at the time of market authorization, FDA may 
advise the manufacturer of the potential 522 order and the surveillance plan schedule, when 
appropriate. Pursuant to section 522(b)(1) each manufacturer must develop and submit for 
FDA approval a postmarket surveillance plan within 30 days8 of receiving the order (see also 
21 C.F.R. 822.9 and 822.10). Section 522(b)(1) of the FD&C Act provides that a 
manufacturer must commence postmarket surveillance not later than 15 months after the day 
the order is issued. FDA typically considers postmarket surveillance to have commenced 
when the first subject is enrolled as outlined in the approved surveillance plan. For plans that 
do not involve enrollment of subjects (e.g., non-clinical studies), FDA considers postmarket 
surveillance to have commenced when data accrual has started as outlined in the approved 
surveillance plan.9  
 
In FDAs experience, surveillance plans that require enrolling subjects in a prospectively-
targeted manner are more likely to achieve timely completion by following the recommended 
schedule below from the date of issuance of the 522 order.  
    
  Study commenced within 15 months  
 
6 21 CFR 822.5. 
7 Ibid 
8 Use of the term days or calendar days throughout this guidance is intended to refer to calendar days and 
distinguish calendar days from working days (as specified in 21 CFR 822.34). 
9 For non-clinical surveillance/studies data, accrual milestone reports may be used to track progress. 
8 
  Contains Nonbinding Recommendations 
 
 
  20% of subjects enrolled within 18 months 
  50% of subjects enrolled within 21 months 
  100% of subjects enrolled within 24 months 
 
III.  Postmarket Surveillance Plans 
FDA will assign a postmarket surveillance (PS) order number (i.e., PS######) to each 522 
order. Manufacturers should cite the assigned PS order number when submitting a proposed 
postmarket surveillance plan. Surveillance plans are reviewed under the assigned PS order 
number. If there are multiple postmarket surveillance questions in a 522 order that require 
different methodologies to address each question, then a separate postmarket surveillance plan 
should be submitted for each question, and it is tracked as an individual requirement under the 
PS order number. FDA will confirm receipt and identify each plan submission by a unique 
document number.10  
 
A manufacturer must submit a postmarket surveillance plan within 30 calendar days of receipt 
of the 522 order.11 Per Section 522(b)(1) of the FD&C Act and 21 CFR 822.17, FDA will 
review postmarket surveillance plans and respond within 60 calendar days of receipt. FDA 
intends to promptly review postmarket surveillance plans and work interactively with the 
manufacturer in order to issue a decision within 30 calendar days of receiving the plan. The 
manufacturer should prioritize resolution of any surveillance plan deficiencies identified by 
the Agency and work interactively with the FDA to facilitate that a full surveillance plan 
review can be achieved within 60 calendar days from the issuance of the 522 order date.  
 
 
The general content and format of a postmarket surveillance submission is outlined in 21 CFR 
822.9. See Appendix 1 for FDAs internal checklist for determining whether a submission is 
administratively complete in accordance with 21 CFR 822.9.  
 
 
As outlined in 21 CFR 822.10, the following sections must be included in your postmarket 
surveillance plan: 
  postmarket surveillance plan objectives addressing the surveillance question(s)12  
  postmarket surveillance approach (i.e., design) or methodology to be used13 (see 
Section III.E. of this guidance); we recommend including the hypothesis(es) and 
success criteria  
 
10 See 21 CFR 822.8. 
11 Section 522(b)(1) of the FD&C Act and 21 CFR 822.8. 
12 21 CFR 822.10(a) 
13 21 CFR 822.10(d) 
9 
  Contains Nonbinding Recommendations 
 
 
  the subject of the study,14 e.g., the patient population (may include subject inclusion 
and exclusion criteria and definition, source of comparator group, and targets for 
ensuring diversity with respect to sex,15 age, race, and ethnicity16, as appropriate) 
  the variables and endpoints for assessing the surveillance question(s),17 such as the 
primary and secondary endpoints; we recommend including definitions for endpoints, a 
list of expected adverse events/complications, an agreement to collect unexpected 
adverse events, and a plan to assess relatedness of endpoints with the device and/or the 
procedure 
  sample size;18 we recommend including sample size calculation that is statistically 
justified and based on study hypothesis, where applicable 
  description of the data source (e.g., hospital records, registry data);19 we recommend 
including description of the data source relevance (e.g., does it capture information to 
address the surveillance question(s) in the order?) and of its reliability (e.g., data 
quality) 
  description of data collection plan20 (such as procedures, including data management 
and quality control where applicable21) 
  data collection forms,22 informed consent forms,23 and Institutional Review Board 
(IRB) approval or IRB exemption documentation,24 where applicable  
  patient follow-up plan or schedule;25 we recommend including length of follow-up, a 
plan to minimize losses to follow-up assessments, estimated follow-up rate, as well as a 
description of baseline and follow-up assessments 
  all data analyses and statistical tests planned26 (such as statistical analysis plan) 
  investigators agreement, if applicable27 
 
14 21 CFR 822.10(b) 
15 See FDA guidance, Evaluation of Sex-Specific Data in Medical Device Clinical Studies (available at 
https://www.fda.gov/media/82005/download). 
16 See FDA guidance, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device 
Clinical Studies (available at https://www.fda.gov/media/98686/download). 
17 21 CFR 822.10(c) 
18 21 CFR 822.10(e) 
19 21 CFR 822.10(g) 
20 21 CFR 822.10(h) 
21 FDA notes that, where appropriate, it may be possible to meet a 522 order requirement through prospective or 
retrospective analysis of data from RWD sources, such as device registries and electronic health records. In addition, 
if RWD already exist that are of sufficient relevance and reliability and a prospective analysis will be timely 
performed by a device manufacturer, FDA may decide not to issue a 522 order. For additional information on the 
use of real-world evidence for medical devices, see FDA Guidance, Use of Real-World Evidence to Support 
Regulatory Decision-Making for Medical Devices, available at https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices. 
22 21 CFR 822.10(h) 
23 21 CFR 822.10(i) 
24 21 CFR 822.10(j) 
25 21 CFR 822.10(k) 
26 21 CFR 822.10(n) 
27 21 CFR 822.10(f) 
10 
  Contains Nonbinding Recommendations 
 
 
  procedures for monitoring conduct and progress of the surveillance,28 and estimate of 
the duration of the surveillance,29 such as plan milestones/timeline elements, we 
recommend including (where applicable): 
  expected monthly number of study sites with IRB approvals 
o
  expected dates for achieving enrollment milestones (e.g., first subject, 20%, 
o
50%, and 100%)  
  expected date to complete follow-up of all study participants, and 
o
  if applicable, information related to intermediate milestones (e.g., evaluation of 
o
surrogate endpoints in a study that also measures clinical benefits) 
 
FDA expects for manufacturers to meet elements set forth in and committed to in the 
postmarket surveillance plan.30 The milestones identified in the postmarket 
surveillance plan will be the milestones which FDA intends to use to assess study 
status (see Sections III.D., IV, V, IX, and X for additional details related to reports and 
postmarket surveillance status). 
 
  The content and timing of the Postmarket Surveillance Reports31 
 
In addition to the items above, FDA also recommends the postmarket surveillance plan 
include the following: 
  an interim data release plan (include frequency of interim analyses, type of analysis, 
data endpoints that will be assessed, content (i.e., endpoints to be posted), and 
proposed frequency of posting on the FDAs 522 Postmarket Surveillance Studies 
Database webpage). 
  a background section (e.g., a brief description of the device, the regulatory history, the 
indications for use), and enrollment and recruitment plan. 
 
In general, section 522(b)(1) of the FD&C Act authorizes FDA to order prospective 
postmarket surveillance for duration of up to 36 months unless the manufacturer and FDA 
agree to extend that timeframe or, if there is no agreement, after the completion of a dispute 
resolution as described in section 562 of the FD&C Act. Further, under section 522(b)(2) of 
the FD&C Act, FDA may by order require a prospective surveillance period of more than 36 
months with respect to a device that is expected to have significant use in pediatric 
populations, if such period is necessary in order to assess the impact of the device on growth 
and development, or the effects of growth, development, activity level, or other factors on the 
safety or efficacy of the device. FDA may work interactively with the manufacturer to help 
FDA determine the appropriate time frame for a pediatric 522 postmarket surveillance study. 
 
 
FDA will evaluate the proposed surveillance plan to determine whether it is administratively 
 
28 21 CFR 822.10(l) 
29 21 CFR 822.10(m) 
30 21 CFR 822.20 
31 21 CFR 822.10(o) 
11 
  Contains Nonbinding Recommendations 
 
 
complete, whether the person designated to conduct the surveillance has appropriate 
qualifications and experience to undertake such surveillance, and if the plan will result in the 
collection of useful data that can reveal unforeseen adverse events or other information 
necessary to protect the public health and will answer the surveillance question(s).32 
Accordingly, FDA may issue one of the following letters:33  
 
  Not Acceptable Letter  This letter is issued when a submission is found to be 
administratively incomplete because it does not include the items required by 21 CFR 
822.9 and 822.10 to allow for a substantive review. See Appendix 1 for FDAs internal 
checklist for determining whether a submission is administratively complete. 
  Approval Letter  This letter indicates FDAs approval of the proposed surveillance 
plan as submitted, along with any specific requirements or recommendations related to 
the surveillance plan. 
 
  Major Deficiency Letter  This letter cites serious deficiencies relating to whether the 
plan will result in the collection of useful data that will answer the surveillance 
questions. The manufacturer must address these deficiencies and/or requests for 
specific information within the specified timeframe before the surveillance plan can be 
approved.34 
 
  Disapproval Letter  This letter indicates FDAs disapproval of the plan submitted 
because FDA has determined it is not likely to result in the collection of useful data that 
will address the postmarket surveillance questions in the 522 order. The letter directs 
the manufacturer to revise its surveillance plan by submitting an entirely new 
submission within the specified timeframe that proposes a new surveillance plan 
intended to address the postmarket surveillance questions in the 522 order. 
 
If a manufacturer disagrees with FDA about the content of the surveillance plan or if the 
surveillance plan is disapproved, possible recourse options are described in 21 CFR 822.22. 
These include seeking internal review of FDAs decision under 21 CFR 10.75; requesting an 
informal hearing under 21 CFR Part 16; or requesting review by the Medical Devices Dispute 
Resolution Panel of the Medical Devices Advisory Committee. A manufacturer may also 
request a meeting with the FDA employee that has signed the 522 order. During the pendency 
of such review, FDA does not intend to take enforcement action except as indicated in Section 
X. 
 
FDA developed this guidance document, in part, to help facilitate timely discussions with 
manufacturers on postmarket surveillance plans, issues and challenges. Early and ongoing 
 
32 See 522(b)(1) of the FD&C Act and 21 CFR 822.16. 
33 See 21 CFR 822.19. FDA plans to use similar decision letters for supplements submitted by 
manufacturers proposing changes to approved surveillance plans. 
34 Consistent with FDAs approach to least burdensome provisions as outlined in the guidance Developing and 
Responding to Deficiencies in Accordance with the Least Burdensome Provisions (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/developing-and-responding-deficiencies-accordance-least-burdensome-
provisions) if only minor deficiencies are identified, FDA intends to resolve such outstanding issues interactively.  
12 
  Contains Nonbinding Recommendations 
 
 
interactions with FDA should be the primary method to ensure the adequacy of 522 
surveillance plans and to resolve any issues. FDA intends to work with manufacturers on the 
development of their surveillance plans, including the timelines and expectations for 
commencing and progress of the postmarket surveillance, and plan for posting of any interim 
data that may be supplied on FDAs website. However, if FDA is unable to complete the 
review of the postmarket surveillance plan within 60 calendar days of issuance of a 522 order 
due to outstanding deficiencies that the manufacturer needs to address, we intend for the 
postmarket surveillance to be categorized as Plan Overdue on FDAs website.35 Moreover, 
once the Secretary issues an order under section 522 requiring a manufacturer to conduct 
postmarket surveillance, if a manufacturer fails to submit a plan within 30 calendar days of 
the 522 order, fails to have an approved postmarket surveillance plan, or fails to commence 
postmarket surveillance within 15 months of the 522 order, this would constitute a failure to 
comply with a requirement under section 522. Failure to comply with a requirement under 
section 522 of the FD&C Act may result in enforcement action by FDA, as appropriate (See 
Section X.) 
 
 
If a manufacturer wishes to propose a change to an approved postmarket surveillance plan that 
will affect the nature or validity of the data collected, the manufacturer must obtain FDA 
approval in writing before making such changes.36 Examples of changes to an approved 
postmarket surveillance plan that FDA may consider to affect the nature or validity of the data 
collected could include changes to sample size, endpoints, follow-up assessments, etc. The 
manufacturer should not combine such a surveillance plan change with any 522 reports, but 
instead should submit a supplement to the PS order number (PS######) with the request and 
the revised postmarket surveillance plan for FDA review. Changes in the postmarket 
surveillance plan that will not affect the nature or validity of the data collected in accordance 
with the plan must be reported in the next interim report as required by the order.37    
 
FDA understands that study delays sometimes may occur, however, FDA generally does not 
intend for manufacturers to routinely modify the postmarket surveillance plan to adjust study 
milestones. Manufacturers may request changes to the original enrollment milestones and 
FDA intends to consider each request on a case-by-case basis. An example of where a change 
to the original study milestone could be appropriate might be when new information indicates 
that the original study enrollment milestones were impractical at the time of the postmarket 
surveillance plan approval. However, based on its past experience, FDA expects that revisions 
to the original study milestones in the surveillance plan may only be appropriate in limited 
circumstances and the agency intends to determine the postmarket surveillance progress and 
to designate its status (e.g., as pending, ongoing, overdue, delayed, or non-compliant) based 
on the milestones as specified in the approved surveillance plan. See Section IV and Section 
V.C for recommendations regarding the communication of anticipated or occurring study 
delays in status reports. See Section VI for considerations for mitigating study delays. 
 
35 522 Postmarket Surveillance Studies Database webpage: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm 
36 See 21 CFR 822.21. 
37 Ibid. 
13 
  Contains Nonbinding Recommendations 
 
 
  
In keeping with FDAs practice of focusing review resources on complete submissions, 
requests to change an approved postmarket surveillance plan will first undergo acceptance 
review to assess whether a supplement is administratively complete for FDA to conduct a 
substantive review.38 If a supplement does not include the items listed in Appendix 1, a Not 
Acceptable letter may be issued identifying the missing items, which the manufacturer would 
need to provide in order for FDA to conduct a substantive review of the supplement. 
 
Once accepted for substantive review, FDA may also find other deficiencies with a 
supplement, and issue a Major Deficiency letter identifying those issues that the manufacturer 
would need to address in order to receive approval. Or, if FDA determines that a proposed 
modification to an approved plan is not likely to result in the collection of useful data that will 
address the postmarket surveillance question, FDA will issue a Disapproval letter identifying 
the reasons for disapproval.39 
 
Unless FDA approves the revised surveillance plan, the manufacturer remains responsible for 
completing the postmarket surveillance following the previously approved surveillance plan. 
Failure to meet the milestones and timelines outlined in the approved surveillance plan may 
result in enforcement action by FDA (see Section X). 
 
 
FDA may order postmarket surveillance to address a wide variety of device-related public 
health questions. When developing a surveillance plan, FDA and the manufacturer should 
consider a least burdensome approach that is scientifically appropriate to address the 
surveillance question(s).40 A 522 order may include multiple public health questions. If more 
than one postmarket surveillance study is needed to address the postmarket questions, each is 
tracked as a unique requirement under the 522 order. FDA also notes that, where appropriate, 
it may be possible to meet a 522 order requirement through prospective or retrospective 
analysis of data from RWD sources, such as device registries and electronic health records.41  
 
Table 1 below describes different types of postmarket surveillance designs that could be used 
depending on the particular public health question. 
 
 
Table 1. Types of Postmarket Surveillance Designs 
 
38 See 21 CFR 822.16. 
39 See 21 CFR 822.19. 
40 See FDA Guidance, Least Burdensome Provisions: Concept and Principles, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-
and-principles. 
41 See FDA Guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-
support-regulatory-decision-making-medical-devices. 
14 
  Contains Nonbinding Recommendations 
 
 
Type  Design 
Randomized Clinical  Prospective study comparing the effects of one or more 
Trial  intervention(s) against a control group. Subjects are assigned 
randomly to one of the study groups. 
Prospective Cohort  A study in which the subjects in a defined population are followed 
Study  prospectively in time to assess the occurrence of outcomes of interest 
as they occur. Such studies can include one or more groups defined in 
terms of their exposure to a device. There is no randomization of 
treatment assignment.  
Retrospective Cohort  A study in which the subjects in a defined population are followed 
Study  forward in time; however, unlike a prospective cohort study, the data 
records documenting the device exposure and outcomes have been 
collected in the past relative to the time when the study is initiated. 
Such studies can include one or more groups defined in terms of their 
exposure to a device. There is no randomization of treatment 
assignment.  
Cross-Sectional  A study in which the presence or absence of an exposure and health 
Study  outcome are assessed at the same point in time. 
Enhanced Surveillance  Continued monitoring of the distribution and trends in the incidence 
of adverse events through ongoing, passive, but systematic collection, 
analysis, and interpretation of data. A passive approach to 
surveillance means that the organization conducting the surveillance 
does not contact potential reporters and leaves the initial reporting to 
others. The surveillance may be designed to collect information on 
events that are both MDR-reportable and MDR non-reportable 
adverse events or device complaints. 
Active Surveillance  Continued monitoring of the distribution and trends in the incidence 
of adverse events through ongoing, active systematic collection, 
analysis, and interpretation of data. An active approach means that 
the organization conducting the surveillance initiates procedures to 
obtain reports. The surveillance may be designed to collect 
information on events that are both MDR-reportable and MDR non-
reportable adverse events or device complaints. 
Meta-Analysis  Systematic review that combines the results of several studies that 
address a set of related research hypotheses. This is normally done by 
identification of a common measure of effect size, which is modeled 
using a form of meta-regression of the published or unpublished 
study data. 
Prospective &  A hybrid cohort study in which data are collected both retrospectively 
Retrospective Study  and prospectively. There is no randomization of the treatment 
assignment.  
Case Control Study  Study in which subjects are identified on the basis of the presence of 
an outcome (cases) and compared to an appropriate comparison group 
(non-cases). The proportions with the exposure of interest are 
compared and Odds Ratios for the outcome(s) of interest are 
calculated. 
15 
  Contains Nonbinding Recommendations 
 
 
Type  Design 
Non-Clinical Study  A study that involves testing on the bench or laboratory setting (e.g., 
wear testing, fatigue testing). 
Animal Study42  A study that involves animal testing (e.g., device or material 
implanted in animal). 
Other Design  A surveillance methodology that does not fit one of the other 
categories.  
 
 
 
IV.  When and How to Submit Postmarket Surveillance 
Reports 
Per 21 CFR 822.38, manufacturers must submit interim and final reports as specified in the 
postmarket surveillance plan. A 522 order can include the timing of reports. FDA 
recommends submitting two types of interim reports: Enrollment Reports and Interim 
Postmarket Surveillance Status Reports. An Enrollment Report provides the progress 
towards meeting the enrollment milestones specified in the postmarket surveillance plan. For 
Enrollment Reports, the timing can be based on the expected completion dates for those 
enrollment milestones. An Interim Postmarket Surveillance Status Report includes subject 
accountability as well as device performance data. There may be instances in which the timing 
for submission of an Enrollment Report coincides with the timing for an Interim Postmarket 
Surveillance Status Report. In such instances, a manufacturer can submit one report labeled as 
Enrollment and Interim Postmarket Surveillance Status Report. 
 
The Final Postmarket Surveillance Report is a written report of a postmarket surveillance 
requirement that has been completed or terminated.  
   
Unless alternative timeframes are specified in the 522 order, for each postmarket surveillance 
requirement, manufacturers should submit an Interim Postmarket Surveillance Status Report 
every 6 months for the first 2 years of the postmarket surveillance and annually, thereafter, 
from the date of the 522 postmarket surveillance plan approval or other agreed-upon starting 
date, separately for each unique requirement. Manufacturers should continue this reporting 
schedule, for each unique requirement, until the Final Postmarket Surveillance Report(s) are 
submitted. In accordance with the 522 order, the Final Postmarket Surveillance Report should 
be submitted no later than three months after study/surveillance completion for the particular 
postmarket surveillance requirement, which FDA considers to have occurred when the last 
data point is collected during the surveillance period (e.g., when the last subject completes the 
last follow-up visit).43  
 
 
42 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage manufacturers to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method.  
43 For non-clinical surveillance/studies submission of final report is expected no later than three months from the 
date the last datapoint was captured.  
16 
  Contains Nonbinding Recommendations 
 
 
In order to ensure proper review, the manufacturer should indicate the type of report and the 
time span on the report cover letter in bold letters (e.g., Enrollment Report, 6-Month 
Interim Postmarket Surveillance Status Report, 12-Month Interim Postmarket 
Surveillance Status Report, Final Postmarket Surveillance Report). For final reports, 
FDA also recommends that manufacturers clearly identify the postmarket surveillance 
requirement (i.e., public health question(s)) for which the report is being submitted.  
 
Section 522 is not subject to section 745A(b) of the FD&C Act [21 U.S.C.  379k-1(b)], 
regarding electronic copy (eCopy) requirements. However, submission of an eCopy is 
recommended for all postmarket surveillance plan submissions. If you choose to submit an 
eCopy, the eCopy should be accompanied by a paper copy of your signed cover letter and 
should be sent to the current address displayed on the eCopy Program webpage 
http://www.fda.gov/cdrhsubmissionaddress. Refer to FDA Guidance, eCopy Program for 
Medical Device Submissions, for additional information on the eCopy program.44 
 
V.   Content and Format of Postmarket Surveillance 
Reports 
FDAs ability to adequately track and evaluate postmarket surveillance depends on the quality 
and timeliness of information provided. The recommendations in this section are intended to 
help ensure that Postmarket Surveillance Reports contain adequate information for the 
Agency to identify the device being studied, the specific postmarket surveillance being 
conducted, the status of that postmarket surveillance, and, if applicable, the reasons for any 
delays or failures to complete the postmarket surveillance. 
 
FDA recommends that Postmarket Surveillance Reports (interim and final) include the 
information listed below, clearly identified, and in separate sections. All reports should 
contain the data listed below and submitted per the timeline in the postmarket surveillance 
plan. 
 
 
FDA recommends all reports include a section that contains the following general 
information: 
 
  Postmarket surveillance tracking number (i.e., PS######) 
  Manufacturer name and contact information (name of the individual or entity holding 
the approved PMA, or HDE, cleared 510(k), or De Novo order): 
  Company Name/Institution Name 
o
  Street Address 
o
  City 
o
  State/Province 
o
 
44 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-
medical-device-submissions  
17 
  Contains Nonbinding Recommendations 
 
 
  ZIP/Postal Code 
o
  Phone Number (include area code) 
o
  Contact name and title 
o
  Contact e-mail address 
o
  Date of issuance of the 522 order 
  Date of postmarket surveillance plan approval and, if applicable, dates of approval of 
any plan revisions 
  Device trade name(s), subject to the 522 order 
  Device model number(s), subject to the 522 order 
  Report information: 
  Date of the report 
o
  Description of the data included in the report, including: 
o
  Enrollment data 
  Clinical study data 
  Non-clinical data (e.g., bench/laboratory) 
  Animal45 study data 
  Other 
  Type of submission: 
  Enrollment Report 
o
  Interim Postmarket Surveillance Status Report 
o
  Final Postmarket Surveillance Report  
o
  Response to FDA correspondence for a deficient report or another reason 
o
(specify) 
 
FDA intends to review Enrollment Reports to assess progress towards the surveillance plan 
milestones. If the postmarket surveillance plan involves new enrollment of subjects,46 FDA 
may request a manufacturer to submit Enrollment Reports until enrollment is completed. The 
Enrollment Reports should include sufficient information to allow FDA and the manufacturer 
to track progress towards the enrollment milestones specified in the postmarket surveillance 
plan, including: 
 
  Begin and end dates of period covered by the report 
  Start and completion dates for clinical site(s) recruitment 
  Number of IRB approvals and number of clinical sites at which the surveillance was 
initiated 
  Subject-enrollment start date and expected completion date 
  Number of subjects enrolled (if applicable, this information should be presented for the 
 
45 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage manufacturers to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
46 For non-clinical surveillance data, accrual milestone reports may be used to track progress. 
18 
  Contains Nonbinding Recommendations 
 
 
entire subject population and for each subgroup, including sex,47 age, race, and 
ethnicity48, as appropriate) 
  Comparison of target versus actual enrollment dates based on enrollment milestones 
specified in the postmarket surveillance plan  
 
 
FDA recommends Interim Postmarket Surveillance Status Reports include (as applicable): 
 
  purpose of the postmarket surveillance, including goals, objectives, and primary and 
secondary endpoints 
  begin and end dates of period covered by the report 
  date of database closure for the report (should not exceed three months prior to the 
submission of report) 
  if clinical study:  
  description of the patient population being studied, including: 
o
  specific illness or condition 
  whether the postmarket surveillance targets subpopulations (e.g., pediatric, 
geriatric), and targets for ensuring diversity with respect to sex,49 age, race, 
and ethnicity50, as appropriate 
  total number of subjects to be studied 
  schedule of subject follow-up 
  subject accountability (e.g., enrolled, randomized, completed, withdrawn, lost 
o
to follow-up) at each follow-up timepoint for the entire population and broken 
down by subgroups, if applicable. To limit the potential bias in safety and 
effectiveness data, manufacturers should make every effort to reduce the 
number of subjects lost to follow-up. 
   if applicable, an explanation for: 
o
  delays in enrollment and plans to address challenges and meet enrollment 
milestones specified in the postmarket surveillance plan 
  subjects lost to follow-up, as well as any measure to minimize such future 
events 
  subject and healthcare provider-initiated discontinuations 
  any deaths, including reports from post-mortem examinations 
  summary and interpretation of interim safety/effectiveness findings, as specified in the 
postmarket surveillance plan 
  proposed interim summary data to be posted on FDA's 522 Postmarket Surveillance 
 
47 See FDA guidance, Evaluation of Sex-Specific Data in Medical Device Clinical Studies (available at 
https://www.fda.gov/media/82005/download). 
48 See FDA guidance, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device 
Clinical Studies (available at https://www.fda.gov/media/98686/download). 
49 See FDA guidance, Evaluation of Sex-Specific Data in Medical Device Clinical Studies (available at 
https://www.fda.gov/media/82005/download). 
50 See FDA guidance, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device 
Clinical Studies (available at https://www.fda.gov/media/98686/download). 
19 
  Contains Nonbinding Recommendations 
 
 
Studies Database webpage51 
 
FDA recommends Final Postmarket Surveillance Reports include (as applicable): 
 
  purpose of the postmarket surveillance, including goals, objectives, and primary and 
secondary endpoints 
  begin and end dates of period covered by the final report 
  date of database closure for the final report  
  if clinical study: 
  patient population being studied, including: 
o
  specific illness or condition 
  whether the postmarket surveillance targets subpopulations (e.g., pediatric, 
geriatric), and targets for ensuring diversity with respect to sex,52 age, race, 
and ethnicity53, as appropriate 
  total number of subjects to be studied 
  schedule of subject follow-up 
  final accountability of enrolled subjects, compared to target  
o
  final accountability of number of subjects (e.g., enrolled, randomized, 
o
completed, withdrawn, lost to follow-up) at each follow-up timepoint, for the 
entire population and broken down by subgroups, if applicable  
   if applicable, an explanation for: 
o
  subjects lost to follow-up, if known  
  subject and healthcare provider-initiated discontinuations 
  any deaths, including reports from post-mortem examinations 
  assessment of potential bias introduced by losses to follow-up (e.g., are 
subjects lost to follow-up different from those that remain under 
surveillance? Is the loss to follow-up differential by study group?) and 
impact on interpretation of results  
  summary and interpretation of final safety/effectiveness findings 
  proposed summary data to be posted on FDAs 522 Postmarket Surveillance Studies 
Database webpage54   
VI.  Evaluation of Interim Postmarket Surveillance Reports 
FDA intends to consider multiple factors when evaluating an Interim Postmarket Surveillance 
Study Report, including: 
 
  the completeness of the report content (especially in regard to progress towards 
 
51 FDA will make the final determination of what information is posted on the 522 Postmarket Surveillance Studies 
Database webpage based on the totality of our review and consistent with applicable disclosure laws.  
52 See FDA guidance, Evaluation of Sex-Specific Data in Medical Device Clinical Studies (available at 
https://www.fda.gov/media/82005/download). 
53 See FDA guidance, Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device 
Clinical Studies (available at https://www.fda.gov/media/98686/download). 
54 Ibid. 
20 
  Contains Nonbinding Recommendations 
 
 
achieving primary and secondary endpoints and performance goals, or sufficient 
individual endpoint data to infer progress in the case of composite endpoints) 
  adherence to methodology in the postmarket surveillance plan and reasons for 
deviations from the methodology 
  whether information in the reports address the public health question(s) 
  the expected versus actual status of the study at the time of the report (especially 
timeliness in recruitment of subjects and sites to the study and adherence to the 
timeline in the postmarket surveillance plan) 
  the causes for delays in postmarket surveillance progress or failure to meet enrollment 
milestones approved in the postmarket surveillance plan, and plan to address 
challenges and meet established milestones 
  When a sponsor fails to meet those enrollment milestones, FDA expects sponsors 
o
to act with due diligence to mitigate continued study delays. FDA intends to 
consider the sponsors mitigations to address study delays. Mitigation efforts FDA 
may consider include, but are not limited to the following: 
 
-  current and past enrollment recovery efforts; 
-  evaluation of slow enrollment; 
-  device availability on the market; 
-  measures taken to initiate study sites; 
-  measures taken to incentivize study subjects; 
-  outreach to study investigators and potential subjects; and 
-  plans to remove barriers to site and subject participation. 
 
Although it is recommended that the manufacturer identify any missed milestones as part of 
postmarket surveillance reports, the manufacturer should communicate circumstances which 
are impacting their ability to meet the milestones in the postmarket surveillance plan to FDA 
as soon as possible. 
 
FDA intends to review Interim Postmarket Surveillance Reports within 30 calendar days from 
submission receipt. If FDA has questions regarding the data provided in the report, or believes 
that the data are incomplete or insufficient, FDA will generally request additional information 
interactively and/or through a deficiency letter. If an interim report includes insufficient data 
or the manufacturer failed to meet established enrollment milestones or timelines, FDA 
ultimately may take enforcement actions to ensure compliance with the 522 order, as 
appropriate (see Section X). Additionally, if the data raise new concerns regarding the safety 
and/or effectiveness of a device, FDA may consider taking actions, which may include issuing 
a Safety Communication to provide recommendations on patient management, as appropriate.   
 
VII.  Evaluation of Postmarket Surveillance Final Reports 
and Possible FDA Actions After 522 Order Completion 
FDA recommends the Final Postmarket Surveillance Report describe the methodology and 
results and explain how it fulfills the public health questions identified in the 522 order.  
 
21 
  Contains Nonbinding Recommendations 
 
 
FDA will consider several factors in its evaluation of the Final Postmarket Surveillance 
Report, including:  
  the completeness of the report content; 
  adherence to methodology in the postmarket surveillance plan and reasons for deviations 
from the methodology; 
  evaluation of information in the report to assess the performance of the device; and 
  evaluation of fulfillment of the 522 order (i.e., have the public health questions been 
addressed). 
 
FDA intends to complete its review of a manufacturers Final Postmarket Surveillance Report 
submission and respond within 60 calendar days. If FDA concludes that the manufacturer has 
fulfilled the obligations in the 522 order, FDA will send a letter to the manufacturer reflecting 
that decision. However, if the results of the postmarket surveillance raise new issues or 
questions, additional actions may be warranted. In such circumstances, FDA could, for 
example: 
 
  request changes to the labeling of the device to reflect additional information learned 
from the postmarket surveillance; 
  issue a new 522 order to address new issues; 
  consider other actions to protect the public health (e.g., request an update to a devices 
indications for use statement); or 
  consider clinical recommendations to guide patient management (e.g., Safety 
Communication), as appropriate. 
 
VIII.  Manufacturers Reporting Status 
Upon receipt of an Interim or Final Postmarket Surveillance Report, FDA determines your 
reporting status based on the schedule in the postmarket surveillance plan. The reporting 
status categories are included in Table 2 below. The reporting status for each postmarket 
surveillance study is posted in the 522 Postmarket Surveillance Studies Database webpage.55  
 
Table 2. Reporting Status Categories 
Status    Definition 
Report on Time  FDA has received the scheduled Interim or Final 
Postmarket Surveillance Report by the due date set in the 
agreed-upon schedule. 
Report Overdue  FDA has not received the Interim or Final Postmarket 
Surveillance Report by the due date set in the agreed-upon 
schedule. 
Report  FDA has received the Interim or Final Postmarket 
Overdue/Received  Surveillance Report, although receipt was after the due 
date set in the agreed-upon schedule. 
 
 
55 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm  
22 
  Contains Nonbinding Recommendations 
 
 
IX.  Postmarket Surveillance Status  
After the review of a supplement with a postmarket surveillance plan, or of an interim56 or 
final report, FDA will consider the manufacturers progress with completing the postmarket 
surveillance. Factors in considering the postmarket surveillance status include, as applicable:  
1.  Assessing the status of surveillance plan approval 
2.  After surveillance plan approval, assessing the following:  
a.  Whether the surveillance plan milestones are met 
b.  Progress with data accrual 
c.  Submission of a final report  
 
Based on the above, FDA will review the potential progress categories (see Table 3 below) 
and consider the appropriate progress status to be posted on the 522 Postmarket Surveillance 
Studies Database webpage.57, 58 Information regarding study status is typically communicated 
to sponsors prior to updates on the 522 webpage. Of note, there may be circumstances in 
which a postmarket surveillance requirement may be put on a temporary hold, be redesigned, 
or terminated. A manufacturers progress status is considered based on current information 
available to the agency and may be revised accordingly based on the availability of new 
information. Each of these status categories are described in Table 3 below.  
 
 
Table 3. Postmarket Surveillance Status Categories 
Overall Status    Description  
Plan Pending  FDA has not received the postmarket surveillance plan or is 
reviewing the manufacturers proposed postmarket surveillance 
plan, and it has been less than 60 calendar days since issuance of 
the 522 order. 
Plan Overdue  FDA is unable to complete its review of the proposed postmarket 
surveillance plan due to outstanding deficiencies that the 
manufacturer needs to address, and it has been more than 60 
calendar days since issuance of the 522 order. 
Surveillance Pending  This status category is used from the time the postmarket 
surveillance plan is approved to the completion of the review of 
the first Interim Postmarket Surveillance Report.  
Ongoing  The surveillance is proceeding according to, or is ahead of, the 
approved schedule. The FDA considers the surveillance to be 
ongoing until a final report is submitted to the FDA, as long as 
the activities are proceeding according to the approved 
 
56 See Section IV for types of Postmarket Surveillance Reports 
57 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm  
58 FDA updates the 522 Postmarket Surveillance Studies Database on a weekly basis. FDA encourages 
manufacturers to review the status of their postmarket surveillance to ensure its accuracy and if not, contact 
MandatedStudiesPrograms@fda.hhs.gov with questions. 
23 
  Contains Nonbinding Recommendations 
 
 
Overall Status    Description  
surveillance plan. 
Delayed  The progression of the surveillance is behind the approved 
schedule. For example, the enrollment of subjects (or data 
accrual) may or may not have started but the projected date for 
completion of that milestone has passed. Delays can occur in any 
phase of the surveillance, including subject enrollment, analysis 
of data, or submission of the final report to the FDA. While the 
milestones in the postmarket surveillance plan serve as the basis 
for defining the surveillance as delayed, each phase of the 
surveillance will be considered on its own right. If the 
manufacturer has one delayed phase, but gets back on schedule 
during the next phase, the delayed status will no longer apply. 
Non-compliant  The surveillance fails to comply with a requirement under section 
522, e.g., it has been more than 15 months since the 522 order 
date and the surveillance has not commenced. 
Completed  The manufacturer has fulfilled the postmarket surveillance 
requirement(s) and FDA considers the requirement(s) under the 
522 order to be satisfied.  
Terminated  The manufacturer has not fulfilled or cannot fulfill the postmarket 
surveillance requirement identified in the 522 order (i.e., 
postmarket surveillance questions are no longer relevant, dataset 
cannot address public health question(s) in 522 order), and after 
all appropriate efforts to fulfill the requirement have been 
exhausted, FDA has terminated the postmarket surveillance 
requirement.  
Redesigned/Replaced  The manufacturer has not fulfilled or cannot fulfill the 
surveillance requirement in the 522 order as designed and 
approved. All appropriate efforts to fulfill the postmarket 
surveillance requirement have been exhausted, and FDA has 
agreed to allow the manufacturer to redesign or replace the 
approved postmarket surveillance plan with a new surveillance 
plan to address the public health question(s) in the 522 order. The 
new plan supersedes the previous plan.  
Hold  This status reflects when a postmarket surveillance requirement 
has been placed on a hold temporarily. Examples of situations 
when a postmarket surveillance requirement might be temporarily 
paused include the following examples:  
  while a change in ownership is completed, a pending 
separate study is being used to address the public health 
24 
  Contains Nonbinding Recommendations 
 
 
Overall Status    Description  
question(s) in the 522 order,  
  redesigning the device and it needs prior premarket 
authorization to use in study,  
  device has been authorized for marketing in US, but is not 
currently marketed by manufacturer,  
  ceased device sales, but regulatory submission that 
received the 522 order has not been withdrawn. 
When the circumstances supporting the hold have resolved, the 
manufacturer is responsible for implementing the surveillance 
plan. The progress is assessed against the milestones approved in 
the postmarket surveillance plan and time since issuance of the 
revised 522 order.  
Consolidated  The manufacturer has requested to consolidate multiple 522 
orders for devices of a particular device type into one 
consolidated 522 order. FDA has agreed to have the multiple 522 
orders consolidated under one 522 order. 
 
X.  Failure to Comply with Postmarket Surveillance 
Requirements under Section 522 of the FD&C Act 
Failure or refusal to comply with a requirement under section 522 of the FD&C Act, including 
failure to commence surveillance within 15 months of a 522 order, is a prohibited act under 
section 301(q)(1)(C) of the FD&C Act, 21 U.S.C.  331(q)(1)(C), and renders the device 
misbranded under section 502(t)(3) of the FD&C Act, 21 U.S.C.  352(t)(3). Note that 
violations of sections 301(q)(1)(C) or misbranding under section 502(t)(3) may lead to 
enforcement actions including seizure of product, injunction, prosecution, and/or civil money 
penalties, as appropriate.59  
 
Furthermore, the failure to have an approved postmarket surveillance plan or failure to 
conduct postmarket surveillance in accordance with the approved plan could also be the basis 
of enforcement action, as appropriate, because such constitutes failure to comply with section 
522 of the FD&C Act, which is a prohibited act under section 301(q)(1)(C) of the FD&C Act 
and the device would be misbranded under section 502(t)(3) of the FD&C Act (21 CFR 
822.20).  
 
There may be instances in which it is impossible or inappropriate for a manufacturer to 
complete a particular postmarket surveillance order, and manufacturers may request 
exemption from the requirement to conduct postmarket surveillance for their devices, which 
FDA will consider under 21 CFR 822.30. Unless an exemption is granted, manufacturers must 
 
59 21 CFR 822.20 
25 
  Contains Nonbinding Recommendations 
 
 
comply with the 522 order.60 If a manufacturer stops marketing the device subject to the 
postmarket surveillance order, it still must continue to conduct postmarket surveillance in 
accordance with the postmarket surveillance plan unless notified otherwise by the Agency.61 
Requests to terminate or modify postmarket surveillance in such instances will be decided on 
a case-by-case basis but are less likely to be granted for devices that are implanted long-term. 
FDA recommends that manufacturers initiate early communication with FDA if they intend to 
terminate postmarket surveillance prior to fulfilling the postmarket surveillance commitment. 
 
Alternatively, if FDA determines a surveillance plan will no longer answer or adequately 
address questions in a 522 order, for example, because of the postmarket surveillance design, 
or due to a discontinuation in marketing or manufacturing of the device, but the 522 order 
objectives remain important, FDA intends to discuss the establishment of a new postmarket 
surveillance plan and schedule with the manufacturer. 
 
XI.  Public Disclosure of Postmarket Surveillance Plan 
Information and Reports 
After approval of the manufacturers plan, FDA may disclose the contents of the original 
submission and any amendments, supplements, or reports, in accordance with applicable 
disclosure laws, such as the Freedom of Information Act. When FDA discloses such 
information, FDA will continue to protect any trade secret or confidential commercial 
information, as well as any personal privacy information of patients.62  
 
Any postmarket surveillance study that is an applicable device clinical trial as defined in 
section 402(j)(1)(A)(ii) of the PHS Act must comply with registration and results submission 
requirements for such clinical trials. Certain information on clinical trials is publicly available 
on the Clinical Trials webpage. Additional information on these requirements can be found at 
https://clinicaltrials.gov/ct2/manage-recs/background.  
 
 
 
To increase transparency to FDA stakeholders, including consumers, healthcare providers, 
and industry, FDA posts information about postmarket surveillance (e.g., study description, 
status, and interim or final study results, see details below) on the FDA 522 Postmarket 
Surveillance Studies Database webpage.63 As noted above, this information is posted in 
compliance with applicable disclosure statutes and regulations. Postmarket surveillance 
details that may be posted include: 
 
General Information 
  postmarket surveillance application number (i.e., PS#######) 
 
60 21 CFR 822.30 
61 21 CFR 822.28 
62 21 CFR 822.23 
63 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm 
26 
  Contains Nonbinding Recommendations 
 
 
  manufacturer name 
  device name 
  medical specialty (e.g., cardiovascular, orthopedic) 
  date of issuance of the 522 order 
  study/surveillance name 
  most recent surveillance plan approval date 
  study/surveillance plan overall status (see Section IX, Table 3 of this guidance) 
 
General Surveillance Plan Parameters 
  postmarket surveillance design  
  data source(s) 
  comparison group 
  analysis type 
  patient population 
 
Detailed Surveillance Plan Parameters (where applicable) 
  description of the postmarket surveillance design  
  surveillance milestones in the approved surveillance plan 
  sample size (number of subjects and sites) 
  description of study population  
  description of study endpoint(s)  
  follow-up visits and length of follow-up 
 
Interim Postmarket Surveillance Status Report Information 
FDA intends to post on its website, or otherwise make public, postmarket surveillance interim 
results consistent with the interim data release plan in the postmarket surveillance plan. When 
interim data includes additional information that may be beneficial for public awareness that 
is not specified in the interim release plan, FDA may also include these data on the 522 
Postmarket Surveillance Studies Database webpage. If the postmarket surveillance plan does 
not include an interim data release plan, FDA intends to post postmarket surveillance interim 
summary data and/or FDAs analyses thereof when appropriate to protect the public health, 
for example, when interim results raise safety concerns, serves to provide critical device 
performance information, or may otherwise impact treatment. FDA generally considers such 
information to be publicly releasable in accordance with applicable disclosure laws, such as 
the Freedom of Information Act. When sharing information appropriate to protect public 
health, FDA will consider the benefits of sharing the information, as well as other 
considerations on the study conduct. Examples of interim report information that FDA 
publicly discloses include: 
  number of subjects enrolled 
  number of sites enrolled 
  interim safety/effectiveness findings 
 
However, if a manufacturer believes in a particular instance that interim results are prohibited 
from public release; for example, because they constitute personal identifying information, 
trade secrets, or confidential commercial information, they should notify FDA of this in the 
27 
  Contains Nonbinding Recommendations 
 
 
interim report containing the results and explain why they believe disclosure of the data is 
prohibited. 
 
Final Postmarket Surveillance Report Results (where applicable)   
  actual number of subjects enrolled 
  actual number of sites enrolled 
  subject follow-up rate 
  final safety/effectiveness findings and results 
  FDAs interpretation and summation of the study/surveillance strengths and 
weaknesses  
 
Reporting Information 
  Interim and Final Postmarket Surveillance Report(s) schedule 
  due date(s) for Interim and Final reports (based on postmarket surveillance plan) 
  FDA receipt date(s) of Interim and Final Postmarket Surveillance Report(s) 
  receipt status category for Interim and Final Postmarket Surveillance Report(s) 
 
Additional elements may be posted on FDAs website, as permitted by applicable disclosure 
statutes and regulations. 
28 
  Contains Nonbinding Recommendations 
 
 
APPENDIX 1: Section 522 Administrative Checklist 
Review (Per 21 CFR 822.9 & 822.10) 
The following is an internal checklist for use by FDA staff to determine whether a postmarket 
surveillance submission is administratively complete. The checklist can be used by 
manufacturers as a reference when preparing their postmarket surveillance submissions.  
 
Items required  Circle Yes or No 
or N/A 
21 CFR 822.9  The submission must include: 
(a) Organizational/administrative information   
(1) Name and address  Yes or No or N/A 
(2) Generic and trade names of the device  Yes or No or N/A 
(3) Name and address of the contact person for the submission  Yes or No or N/A 
(4) Premarket application/submission number and device identifiers for the device  Yes or No or N/A 
(5) Table of contents identifying page numbers for each section of the submission  Yes or No or N/A 
(6) Description of the device (this may be incorporated by reference to the appropriate  Yes or No or N/A 
premarket application/submission) 
(7) Product codes and list of all relevant model numbers  Yes or No or N/A 
(8) Indications for use and claims for the device  Yes or No or N/A 
(b) Postmarket surveillance plan  Yes or No or N/A 
(c) Designated person information   
(1) Name, address, and telephone number  Yes or No or N/A 
(2) Experience and qualifications  Yes or No or N/A 
21 CFR 822.10  The surveillance plan must include: 
Yes or No or N/A 
(a) The plan objective(s) addressing the surveillance questions identified in the 522 order 
Yes or No or N/A 
(b) The subject of the study, e.g., patients, the device, animals 
(c) The variables and endpoints that will be used to answer the surveillance question, e.g.,  Yes or No or N/A 
clinical parameters or outcomes 
Yes or No or N/A 
(d) The surveillance approach or methodology to be used 
Yes or No or N/A 
(e) Sample size and units of observation 
(f) The investigator agreement, if applicable  Yes or No or N/A 
(g) Sources of data, e.g., hospital records  Yes or No or N/A 
Yes or No or N/A 
(h) The data collection plan and forms 
Yes or No or N/A 
(i) The consent document, if applicable 
29 
  Contains Nonbinding Recommendations 
 
 
Items required  Circle Yes or No 
or N/A 
(j) Institutional review board information, if applicable  Yes or No or N/A 
(k) The patient follow-up plan, if applicable  Yes or No or N/A 
(l) The procedures for monitoring conduct and progress of the surveillance  Yes or No or N/A 
(m) An estimate of the duration of surveillance, e.g., timeline for milestones  Yes or No or N/A 
(n) All data analysis and statistical test planned  Yes or No or N/A 
(o) The content and timing of reports, e.g., reporting schedule  Yes or No or N/A 
 
30