Archive for the 'Medical Devices' Category

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Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 26th, 2005 in Medical Devices

Topics: Dental, Dental Composites

Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System.

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 26th, 2005 in Medical Devices

Federal Register:Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 26th, 2005 in Medical Devices

CFTR Gene Mutation Detection Systems - Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 25th, 2005 in Medical Devices

This document was developed as a special control to support the classification of CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection systems into class II (special controls).

Mammography: 2004 Report to Congress on the Performance of Accreditation Bodies

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 21st, 2005 in Medical Devices

This is the ninth annual Report to Congress on the performance of accreditation bodies under the Mammography Quality Standards Act (MQSA) of 1992, as amended by the Mammography Quality Standards Reauthorization Act (MQSRA) of 2004. The Report, prepared…

Medical Device User Fee and Modernization Act of 2002 (MDUFMA) - Quarterly Update, Oct. 14, 2005

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 21st, 2005 in Medical Devices

Summary Minutes and Transcript for the Orthopaedic and Rehabilitation Devices Panel Meeting - September 8-9, 2005

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 21st, 2005 in Medical Devices

Transcript for the National Mammography Quality Assurance Advisory Committee Meeting - September 26 and 27, 2005

Closed Published by Food and Drug Adminstration (FDA): CDRHNew October 21st, 2005 in Medical Devices

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