Medical Device Regulations

Agency's 510(k) Rescission Plan Criticized

Medical Device Regulations

Agency's 510(k) Rescission Plan Criticized Agency's 510(k) Rescission Plan Criticized

Originally Published MDDI September 2001WASHINGTON WRAP-UP Proposed rule viewed by some as committing "too much to trust."James G. Dickinson

byJames G. Dickinson

Sep 1, 2001

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12 Min Read

Spotlight on EMI/RFI Control

Medical Device Regulations

Spotlight on EMI/RFI Control Spotlight on EMI/RFI Control

Jul 4, 2001

4 Min Read

From Patent to PMA

Medical Device Regulations

From Patent to PMA From Patent to PMA

byStacey L. Bell

Jul 1, 2001

1 Min Read

Putting PMAs, 510(k)s on a Paper Diet

Medical Device Regulations

Putting PMAs, 510(k)s on a Paper Diet Putting PMAs, 510(k)s on a Paper Diet

byJames G. Dickinson

Jun 1, 2001

10 Min Read

Considerations for the Biocompatibility Evaluation of Medical Devices

Medical Device Regulations

Considerations for the Biocompatibility Evaluation of Medical Devices Considerations for the Biocompatibility Evaluation of Medical Devices

May 1, 2001

20 Min Read

Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH

Medical Device Regulations

Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH

May 1, 2001

11 Min Read

Shifting the Device Risk Burden

Medical Device Regulations

Shifting the Device Risk Burden

Shifting the Device Risk Burden

byJames G. Dickinson

Establishment Registration: Keeping Pace with an Evolving Industry

Medical Device Regulations

Establishment Registration: Keeping Pace with an Evolving Industry

Establishment Registration: Keeping Pace with an Evolving Industry

HCFA Under Fire: Frustrations Focus on Reimbursement

Medical Device Regulations

HCFA Under Fire: Frustrations Focus on Reimbursement

HCFA Under Fire: Frustrations Focus on Reimbursement

The Development of a New 510(k) Program

Medical Device Regulations

The Development of a New 510(k) Program

The Development of a New 510(k) Program

File Closes on Document Leak: Final investigation leaves key questions unresolved.

Medical Device Regulations

File Closes on Document Leak: Final investigation leaves key questions unresolved.

File Closes on Document Leak: Final investigation leaves key questions unresolved.

byJames G. Dickinson

How Now, Mad Cow?Strong Measures to Forestall a Potential Killer

Medical Device Regulations

How Now, Mad Cow?Strong Measures to Forestall a Potential Killer

How Now, Mad Cow?Strong Measures to Forestall a Potential Killer

Using Receipt and Decision Cohort Data to Monitor Premarket Review Activities

Medical Device Regulations

Using Receipt and Decision Cohort Data to Monitor Premarket Review Activities

Using Receipt and Decision Cohort Data to Monitor Premarket Review Activities

Judge Permits Spread of Unapproved Uses Literature

Medical Device Regulations

Judge Permits Spread of Unapproved Uses Literature

Judge Permits Spread of Unapproved Uses Literature

byJames G. Dickinson

Taming the Dragon: Understanding and Focusing on EMI

Medical Device Regulations

Taming the Dragon: Understanding and Focusing on EMI

Taming the Dragon: Understanding and Focusing on EMI

The Bug Stops Here: Stricter Environmental Controls Needed

Medical Device Regulations

The Bug Stops Here: Stricter Environmental Controls Needed

The Bug Stops Here: Stricter Environmental Controls Needed

Protecting Devices from Radio-Frequency Transmitters

Medical Device Regulations

Protecting Devices from Radio-Frequency Transmitters

Protecting Devices from Radio-Frequency Transmitters

A Practical Guide to ISO 10993-5: Cytotoxicity

A Practical Guide to ISO 10993-5: Cytotoxicity

A Practical Guide to ISO 10993-5: Cytotoxicity

byRichard F. Wallin

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform

Medical Device Regulations

Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform

Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform

EMI Control: Pulling the Plug on a Global Problem

Medical Device Regulations

EMI Control: Pulling the Plug on a Global Problem

EMI Control: Pulling the Plug on a Global Problem

Canada, EU Experiment with Harmonization

Medical Device Regulations

Canada, EU Experiment with Harmonization

Canada, EU Experiment with Harmonization

byJames G. Dickinson

THE MAKING OF A REGULATORY PROFESSION

Medical Device Regulations

THE MAKING OF A REGULATORY PROFESSION

THE MAKING OF A REGULATORY PROFESSION

THE MAKING OF A REGULATORY PROFESSION

Medical Device Regulations

THE MAKING OF A REGULATORY PROFESSION 2415

THE MAKING OF A REGULATORY PROFESSION

The ISO 9000 Journey

Medical Device Regulations

The ISO 9000 Journey

The ISO 9000 Journey

REUSABLE DEVICES : Validating Reusable Medical Devices: An Overview

Medical Device Regulations

REUSABLE DEVICES : Validating Reusable Medical Devices: An Overview

REUSABLE DEVICES : Validating Reusable Medical Devices: An Overview

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