The Food and Drug Administration (FDA) issued draft guidance on August 15, 2011, to help researchers and manufacturers design better quality clinical studies in support of premarket submission for certain medical devices. The document is also intended to provide guidance to the FDA staff who review those submissions.
Although FDA previously articulated policies related to design of studies intended to support specific device types, and has a general policy of tailoring the evidentiary burden to the regulatory requirement, the agency had not previously attempted to describe the different clinical study designs that may be appropriate to support a device premarket submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device.
The draft guidance document describes principles that should be followed for the design of premarket clinical studies that are pivotal in establishing the safety and effectiveness of a medical device. The guidance applies to therapeutic and aesthetic devices and diagnostic devices. It is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies, but rather, it is intended to complement other existing guidance.
The guidance document is open for public comment. The FDA has requested that interested parties submit their comments by November 14, 2011. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to www.regulations.gov
