FDA Expects Draft Document On Post-Approval Study Design By September

Full article reprinted from "The Gray Sheet" - June 29, 2009

FDA hopes to complete a draft scientific document on how to design post-approval studies for medical devices by September, according to Danica Marinac-Dabic, director of the Division of Epidemiology within CDRH's Office of Surveillance and Biometrics. Read More...

FDA Expects Draft Document On Post-Approval Study Design By September

Full article reprinted from "The Gray Sheet" - June 29, 2009

FDA hopes to complete a draft scientific document on how to design post-approval studies for medical devices by September, according to Danica Marinac-Dabic, director of the Division of Epidemiology within CDRH's Office of Surveillance and Biometrics.

The document will explain when a post-approval study is needed and what type of study is appropriate.

For example, in some cases FDA may ask the manufacturer to do a study comparing patient outcomes with the new device to outcomes of patients treated with another therapy. In other cases, historical control data or objective performance criteria might be sufficient.

Marinac-Dabic also hopes the document will address the question of when to stop requiring post-approval studies of certain device types.

"At what point for Nth of a kind of device are we ready to say we don't need any more collection of data and we can rely on the existing surveillance systems that we already have," such as FDA's adverse event reporting systems? she asked.

Marinac-Dabic said the agency is "long overdue" for creating a policy document on its expectations for post-approval studies. She described the paper under development as a "working document on study designs," as opposed to a formal FDA guidance document.

She said FDA is currently seeking comments on an early version of the document from the device trade group AdvaMed, and hopes to present the final draft at its next post-approval studies public workshop, planned for Sept. 9-10.

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