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FDA Veteran Tapped for AdvaMed Post

Regulatory & Quality

FDA Veteran Tapped for AdvaMed Post FDA Veteran Tapped for AdvaMed Post

Originally Published MDDI May 2003NEWSTRENDS

May 1, 2003

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1 Min Read

IDE Status Offers Direct Route to Reimbursement

Medical Device Regulations

IDE Status Offers Direct Route to Reimbursement IDE Status Offers Direct Route to Reimbursement

May 1, 2003

1 Min Read

Applying Session-Based Testing to Medical Software

Applying Session-Based Testing to Medical Software Applying Session-Based Testing to Medical Software

byBill Wood, David James

May 1, 2003

1 Min Read

Guidance on Quality Information

Guidance on Quality Information Guidance on Quality Information

Apr 1, 2003

1 Min Read

Budget Offers Bleak Device Outlook at FDA

Regulatory & Quality

Budget Offers Bleak Device Outlook at FDA Budget Offers Bleak Device Outlook at FDA

byJames G. Dickinson

Apr 1, 2003

1 Min Read

Getting Started with a Combination ProductPart II: European Regulations

Regulatory & Quality

Getting Started with a Combination ProductPart II: European Regulations Getting Started with a Combination ProductPart II: European Regulations

Apr 1, 2003

1 Min Read

Strategies for Bench Testing Medical Devices

Strategies for Bench Testing Medical Devices

Regulatory & Quality

Testing to Support a 510(k)

Testing to Support a 510(k)

Regulatory & Quality

FDA Publishes Susceptibility Test System Guidance

FDA Publishes Susceptibility Test System Guidance

Regulatory & Quality

FDA Initiative to Speed Availability of Innovative Medical Devices

FDA Initiative to Speed Availability of Innovative Medical Devices

Regulatory & Quality

CDRH Improves PMA Review Times by 11%

CDRH Improves PMA Review Times by 11%

byJames G. Dickinson

Regulatory & Quality

FDA’s Regulation of Analyte-Specific Reagents

FDA’s Regulation of Analyte-Specific Reagents

Medical Device Regulations

Establishing Overall Risk for Medical Devices

Establishing Overall Risk for Medical Devices

byMike W. Schmidt

Regulatory & Quality

Is Your Human Factors Program Ready for FDA Scrutiny?

Is Your Human Factors Program Ready for FDA Scrutiny?

Regulatory & Quality

MDUFMA Spells Change for Manufacturers

MDUFMA Spells Change for Manufacturers

Regulatory & Quality

FDA Aims to Eliminate the "Pre-1976" Stigma

FDA Aims to Eliminate the "Pre-1976" Stigma

byJames G. Dickinson

Medical Device Regulations

The Medical HACCP Alliance

The Medical HACCP Alliance

Rubber presses provide high-quality parts with excellent tolerances.

Rubber presses provide high-quality parts with excellent tolerances.

Regulatory & Quality

Test Methods Become New ASTM Standards

Test Methods Become New ASTM Standards

Regulatory & Quality

New Law Accelerates FDA's Combination Product Reforms

New Law Accelerates FDA's Combination Product Reforms

Regulatory & Quality

FDA Finalizes Guidance on "Least Burdensome" Principles

FDA Finalizes Guidance on "Least Burdensome" Principles

byJames G. Dickinson

Regulatory & Quality

The FDA Approval and Medicare Coverage Processes

The FDA Approval and Medicare Coverage Processes

Regulatory & Quality

Follow the Money: Economics Infiltrates FDA

Follow the Money: Economics Infiltrates FDA

Regulatory & Quality

FDA Tightens Screws on DEHP Use

FDA Tightens Screws on DEHP Use

Medical Device Regulations

Duluth as Trendsetter: Will Its Mercury Ban Catch On?

Duluth as Trendsetter: Will Its Mercury Ban Catch On?

Regulatory & Quality

Congress Enacts Device Law and Confirms FDA Chief

Congress Enacts Device Law and Confirms FDA Chief

byJames G. Dickinson

Regulatory & Quality

Managing Communications with FDA and CMS

Managing Communications with FDA and CMS

Regulatory & Quality

McClellan Confirmed as New FDA Commissioner

McClellan Confirmed as New FDA Commissioner

Spotlight on Testing Equipment and Services

Spotlight on Testing Equipment and Services

Regulatory & Quality

e-Learning Courses Facilitate FDA Compliance

e-Learning Courses Facilitate FDA Compliance

Recovery Testing Terms

Recovery Testing Terms

Regulatory & Quality

FDA's Statland Leaves Lasting Mark

FDA's Statland Leaves Lasting Mark

Industry Confronts Challenge from New Testing Standard

Industry Confronts Challenge from New Testing Standard

Regulatory & Quality

Device Regulation in Asia: An Update

Device Regulation in Asia: An Update

Medical Device Regulations

ISO 9001:2000 vs. ISO 13485:200XThe Basics

ISO 9001:2000 vs. ISO 13485:200XThe Basics

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