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PMA Transformation Team Home

The PMA Transformation team was formed in May of 1997 as part of the Center for Devices and Radiological Health’s re-engineering initiative. The team was asked to examine the investigational device exemption (IDE) and premarket approval (PMA) processes and propose a new model for development and review of class III IDE/PMA medical devices. Our goal was to develop an integrated IDE/PMA process that is continuous, seamless, interactive and decisive; that will accelerate moving new products from the idea stage to the marketplace and facilitate product improvements; and that will allot agency resources commensurate with the expected public health benefit of the device.

The team has developed a new model that we believe is smart, fair and fast. The new model encourages interaction between the agency and the applicant, including early agreement on the overall development plan, offers modular submission and review that will build the application and administrative file over time, and utilizes three tracks that will allocate agency resources according to the expected public health benefit of the device. The new model represents the agency’s current thinking on expediting the IDE/PMA process and does not operate to bind FDA or the public. An alternative approach that satisfies the applicable statute, regulations or both may be used. Documents providing information about the new model are available on this website:

New Model and Pilots

• New Model Medical Device Development Process
• 12/22/97 Letter to IVD Manufacturers on Streamlined PMA PDF
• In Vitro Diagnostic Model for a Pilot for Streamlined PMA Review
• Premarket Approval Application Content Shell
• Guidances for the Medical Device Industry on PMA Shell Development and Modular Review

FDA is interested in receiving comments and suggestions on the new model and pilots. Comments and suggestions can be submitted at any time for agency consideration to the Office of Device Evaluation, HFZ-400, 9200 Corporate Boulevard, Rockville, Maryland 20850.

Updated July 21, 1998

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