While the FDA has articulated policies related to design of studies intended to support specific device types , and a general policy of tailoring the evidentiary burden to the regulatory requirement, the Agency has not, in the past, attempted to describe the different clinical study designs that may be appropriate to support a device pre-market 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.
In November 2013 the Guidance “Design Considerations for Pivotal Clinical Investigations for Medical Devices” was issued, to provide guidance to Industry, Clinical Investigators and Institutional Review Boards, on the study design principles relevant to the development of medical device clinical studies. Even though this guidance is focused on providing recommendations to sponsors on how to design clinical investigations to support a PMA, sponsors who conduct clinical studies to support pre-market notification (510(k)) and de novo submissions may also rely on the principles in this guidance document.
A medical device pivotal study is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves as the primary basis for the determination of reasonable assurance of safety and effectiveness of the medical device of a pre-market approval application (PMA) and FDA’s overall benefit-risk determination. In some cases, a PMA may include multiple studies designed to answer different scientific questions. In this audio session, Angela will present the FDA’s latest thinking on Design Considerations for Pivotal Clinical Investigations for Medical Devices.
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CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA, MIS Director....
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