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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:
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.
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.
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
Your submission must include the following:
Your surveillance plan must include a discussion of:
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:
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.
Contact Information:
Julie A. Unger, Project Manager
Epidemiology Branch, Room 320F, HFZ-541
1350 Piccard Drive
Rockville, Maryland 20850
(240) 276-1478 phone
(240) 276-2377 fax
Updated November 3, 2008
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Center for Devices and Radiological Health / CDRH