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Early Collaboration Meetings Under the FDA Modernization Act (FDAMA) February 19, 1998

General Program Guidance #P98-3 (FDAMA)

Director Office of Device Evaluation (HFZ­400)

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)

ODE Review Staff

Purpose

The FDAMA provides for two early collaboration meetings. These meetings are intended to facilitate interaction between FDA and applicants and provide clear direction for testing and development of those products requiring clinical investigations to support marketing.

Guidance

The attached "Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff" was published on February 19, 1998. It sets forth the procedures for PMA determination meetings and agreement meetings as well as the expectations of the applicant/sponsor and the FDA.

Effective Date: February 19, 1998.

Susan Alpert, Ph.D., M.D.

PDF version of the Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff is also available. Information on Documents in Portable Document Format (pdf) is available.

Updated 6/14/2002

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