Premarket Approval Pma Manual

This manual details the type of information needed in a PMA so that the Food and Drug Administration (FDA) can evaluate the safety and effectiveness of a medical device. Information in this manual is intended to aid applicants in the preparation of a PMA application as required by the Medical Device Amendments of 1976 and the PMA procedura regulation, 21 Code of Federal Regulations, Part 814. This manual contains information on the premarket approval process such as compliance policy and guidance, procedural guidance, and guidance on developing an adequate investigational plan. This manual also addresses the changes in the PMA process required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

The FDA is responsible for oversight of medical devices sold in the U.S. Regulations place devices into 3 classes, with class III including those with the greatest risk to patients. New devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. This report examined which premarket review process -- 510(k) or PMA -- FDA used to review selected types of device submissions in FY 2003 through FY 2007. Includes recommendations. Illus.