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U.S. Department of Health and Human Services

Medical Devices

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Letter to PAS Participants

To:  Participants of Post-Approval Studies

Subject:  Participation in Post-Approval Studies

 

Dear Study Participant:

The Food and Drug Administration (FDA) is writing to you to ask for your continued participation in FDA Post-Approval Studies. First of all, we would like to thank you for taking part in these important studies and for going to the follow-up clinic visits.

The FDA approves medical devices sold in the US. Part of FDA’s mission is to protect the health of the American public by making sure medical devices are safe and work correctly after they are approved. As such, FDA may require companies that make medical devices to do post-approval studies to study a medical device after it is approved. These required post-approval studies can give patients, doctors, device makers, and the FDA valuable information on the safety, effectiveness, and reliability of medical devices.

It will be very hard to get good information from these studies if all of the study members do not go to their follow-up visits. You, as a study member, are an important part of FDA post-approval medical device studies. Since you are a part of a post-approval study, we ask you to go to all scheduled follow-up visits with your doctor. At these follow-up visits your doctor will collect important information on how you are doing.

We are sure that with the help of patients, doctors, and device makers, the FDA Post-Approval Studies will have a public health benefit. We sincerely appreciate you helping the FDA to protect public health by making sure medical devices are safe and effective.

If you have questions about the post-approval studies, please contact Nicole Jones, Post-Approval Studies Manger at nicoles.jones@fda.hhs.gov or 301-796-6062.

 

Sincerely yours,

 

Danica Marinac-Dabic, M.D., Ph.D.
Director, Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration