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Postmarket Surveillance Studies

• Introduction
• Who Must Conduct Postmarket Surveillance Studies
• How and When to Submit a Postmarket Surveillance Plan
• Contents of a Postmarket Surveillance Plan
• Responsibilities after the Postmarket Surveillance Plan is Approved
• Postmarket Surveillance Study Reports
  
• References

Introduction

FDA may order a manufacturer to conduct postmarket surveillance of a medical device under section 522 of the Food, Drug and Cosmetic Act (act). FDA has the authority to order postmarket surveillance of any class II or class III medical device, including a device reviewed under the licensing provisions of section 351 of the Public Health Service Act, that meets any of the following criteria:

1. (a) Failure of the device would be reasonably likely to have serious adverse health consequences;
2. (b) The device is intended to be implanted in the human body for more than 1 year; or
3. (c) The device is intended to be used to support or sustain life and to be used outside a user facility.

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health. Title 21 CFR 822, Postmarket Surveillance, provides procedures and requirements for postmarket surveillance.

Who Must Conduct Postmarket Surveillance Studies

FDA will send you a letter (the postmarket surveillance order) notifying you of the requirement to conduct postmarket surveillance. Before we send the order, or as part of the order, we may require that you submit information about your device that will allow us better to define the scope of a surveillance order. We will specify the device(s) subject to the surveillance order and the reason that we are requiring postmarket surveillance of the device under section 522 of the act. We will also provide you with any general or specific guidance that is available to help you develop your plan for conducting postmarket surveillance.

We will notify you as soon as we have determined that postmarket surveillance of your device is necessary, based on the identification of a surveillance question. This may occur during the review of a marketing application for your device, as your device goes to market, or after your device has been marketed for a period of time.

How and When to Submit a Postmarket Surveillance Plan

You must submit your plan to conduct postmarket surveillance within 30 days from receipt of the order (letter) notifying you that you are required to conduct postmarket surveillance of a device. When we receive your original submission, we will send you an acknowledgment letter identifying the unique document number assigned to your submission. You must use this number in any correspondence related to this submission.

FDA will review your submission within 60 days of receipt. FDA will determine whether the surveillance plan will result in the collection of useful data that will answer the surveillance question and whether the designated person has appropriate qualifications and experience to conduct the surveillance and

Contents of a Postmarket Surveillance Plan

Your submission must include the following:

1. (a) Organizational/administrative information:
   1. (1) Your name and address;
   2. (2) Generic and trade names of your device; |
   3. (3) Name and address of the contact person for the submission;
   4. (4) Premarket application/submission numbers for your device;
   5. (5) Table of contents identifying the page numbers for each section of the submission;
   6. (6) Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);
   7. (7) Product codes and a list of all relevant model numbers; and
   8. (8) Indications for use and claims for the device;
2. (b) Postmarket surveillance plan;
3. (c) Designated person (individual who conducts or supervises the conduct of your postmarket surveillance) information;
   1. (1) Name, address, and telephone number; and
   2. (2) Experience and qualifications.

Your surveillance plan must include a discussion of:

1. (a) The plan objective(s) addressing the surveillance question(s) identified in our order;
2. (b) The subject of the study, e.g., patients, the device, animals;
3. (c) The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;
4. (d) The surveillance approach or methodology to be used;
5. (e) Sample size and units of observation;
6. (f) The investigator agreement, if applicable;
7. (g) Sources of data, e.g., hospital records;
8. (h) The data collection plan and forms;
9. (i) The consent document, if applicable;
10. (j) Institutional Review Board information, if applicable;
11. (k) The patient followup plan, if applicable;
12. (l) The procedures for monitoring conduct and progress of the surveillance;
13. (m) An estimate of the duration of surveillance;
14. (n) All data analyses and statistical tests planned;
15. (o) The content and timing of reports.

Responsibilities after the Postmarket Surveillance Plan is Approved

After we have approved your plan, you must conduct the postmarket surveillance of your device in accordance with your approved plan. This means that you must ensure that:

1. (a) Postmarket surveillance is initiated in a timely manner;
2. (b) The surveillance is conducted with due diligence;
3. (c) The data identified in the plan is collected;
4. (d) Any reports required as part of your approved plan are submitted to us in a timely manner; and
5. (e) Any information that we request prior to your submission of a report or in response to our review of a report is provided in a timely manner.

Postmarket Surveillance Study Reports

You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also state the reason or purpose for the request and how we will use the information.

References

• 21 CFR 822, Postmarket Surveillance
  
  
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act [PDF]
  
  
• Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements [PDF]
  

Updated August 29, 2007

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