Premarket Approval (PMA) Manual
Author: Center for Devices and Radiological Health (U.S.). Office of Device Evaluation
Publisher:
Published: 1986
Total Pages: 144
ISBN-13:
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Author: Center for Devices and Radiological Health (U.S.). Office of Device Evaluation
Publisher:
Published: 1986
Total Pages: 144
ISBN-13:
DOWNLOAD EBOOKAuthor: Charles Kyper
Publisher:
Published: 1993
Total Pages: 250
ISBN-13:
DOWNLOAD EBOOKAuthor: United States. Food and Drug Administration
Publisher:
Published: 1986
Total Pages: 144
ISBN-13:
DOWNLOAD EBOOKAuthor: Charles Kyper
Publisher:
Published: 1993
Total Pages: 256
ISBN-13:
DOWNLOAD EBOOKAuthor: Holstein, Howard M.
Publisher:
Published: 198?
Total Pages:
ISBN-13:
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Publisher:
Published: 1998
Total Pages:
ISBN-13:
DOWNLOAD EBOOKThis 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.
Author: United States. Food and Drug Administration
Publisher:
Published: 1994-03
Total Pages: 36
ISBN-13:
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Publisher:
Published: 1987
Total Pages: 787
ISBN-13:
DOWNLOAD EBOOKAuthor: Marcia Crosse
Publisher: DIANE Publishing
Published: 2009-06
Total Pages: 64
ISBN-13: 1437913059
DOWNLOAD EBOOKThe 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.
Author: FDA.
Publisher:
Published: 1998
Total Pages:
ISBN-13:
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