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Can a Neanderthal Write an Editor's Page?
Regulatory & Quality
Can a Neanderthal Write an Editor's Page?Can a Neanderthal Write an Editor's Page?

Medical Device & Diagnostic Industry MagazineMDDI Article IndexINTO THE INTERNETOriginally Published June 2000

Jun 1, 2000
|
3 Min Read
FDA Proposes Easier Device Tracking Rule
Regulatory & Quality
FDA Proposes Easier Device Tracking RuleFDA Proposes Easier Device Tracking Rule
byJames G. Dickinson
Jun 1, 2000
13 Min Read
Device-Related Testing and Laser Marking Systems Displayed at Electronics Show
Testing
Device-Related Testing and Laser Marking Systems Displayed at Electronics ShowDevice-Related Testing and Laser Marking Systems Displayed at Electronics Show
May 1, 2000
4 Min Read
Finally, FDA Moves Broadly on Device Reprocessors : More Trouble for Abbott : FDA Hepatitis Guidance Needs Expertise :
Regulatory & Quality
Finally, FDA Moves Broadly on Device Reprocessors : More Trouble for Abbott : FDA Hepatitis Guidance Needs Expertise : Special Controls Guidances : HIMA Urges Easier DEHP RuleFinally, FDA Moves Broadly on Device Reprocessors : More Trouble for Abbott : FDA Hepatitis Guidance Needs Expertise : Special Controls Guidances : HIMA Urges Easier DEHP Rule
byJames G. Dickinson
Apr 1, 2000
11 Min Read
Quality Marks on Firing Line at Global Medical Device Conference
Regulatory & Quality
Quality Marks on Firing Line at Global Medical Device ConferenceQuality Marks on Firing Line at Global Medical Device Conference
Mar 1, 2000
3 Min Read
On Reprocessors and Research, FDA Gently Yields : Baxter Warned on Infusion Pumps : Humanitarian Use Exemption Sought :
Regulatory & Quality
On Reprocessors and Research, FDA Gently Yields : Baxter Warned on Infusion Pumps : Humanitarian Use Exemption Sought : Don't Inspect without Cause, HIMA Advises FDA : FDA Allows Abbott Consent-Decree AmendmentOn Reprocessors and Research, FDA Gently Yields : Baxter Warned on Infusion Pumps : Humanitarian Use Exemption Sought : Don't Inspect without Cause, HIMA Advises FDA : FDA Allows Abbott Consent-Decree Amendment
byJames G. Dickinson
Feb 1, 2000
8 Min Read
Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines
Regulatory & Quality
Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines
Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines
Jan 1, 2000
|
18 Min Read
FDA Going "Direct" to Companies
Regulatory & Quality
FDA Going "Direct" to Companies
FDA Going "Direct" to Companies
Jan 1, 2000
|
11 Min Read
byJames G. Dickinson
After Abbott, A Tougher FDA Is Emerging : Targeting Device CEOs Gets Their Attention—and a Fix : FDA Approvals Chief
Regulatory & Quality
After Abbott, A Tougher FDA Is Emerging : Targeting Device CEOs Gets Their Attention—and a Fix : FDA Approvals Chief Departs : Why Don't Device Firms Use Innovative Reviews? : FDA Abandons Internet Promotion Guidance
After Abbott, A Tougher FDA Is Emerging : Targeting Device CEOs Gets Their Attention—and a Fix : FDA Approvals Chief Departs : Why Don't Device Firms Use Innovative Reviews? : FDA Abandons Internet Promotion Guidance
Dec 1, 1999
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10 Min Read
byJames G. Dickinson
A Scholarly Article You Can't Promote : Harmonization Power Grab? : FDA to Appeal Free-Speech Defeat : Y2K Won't Bother Many
Regulatory & Quality
A Scholarly Article You Can't Promote : Harmonization Power Grab? : FDA to Appeal Free-Speech Defeat : Y2K Won't Bother Many Devices : FDA's "Least Burdensome" Guidance
A Scholarly Article You Can't Promote : Harmonization Power Grab? : FDA to Appeal Free-Speech Defeat : Y2K Won't Bother Many Devices : FDA's "Least Burdensome" Guidance
Nov 1, 1999
|
10 Min Read
byJames G. Dickinson
QSIT: The New Quality System Inspection Technique
Regulatory & Quality
QSIT: The New Quality System Inspection Technique
QSIT: The New Quality System Inspection Technique
Oct 1, 1999
|
21 Min Read
byCollins
Novel Devices Won't Suffer, but the Others? : Lab-Test Labeling Guidelines Stir Controversy : Judge Curbs FDA Marketing
Regulatory & Quality
Novel Devices Won't Suffer, but the Others? : Lab-Test Labeling Guidelines Stir Controversy : Judge Curbs FDA Marketing Rules : Group Seeks Action against Reprocessors : HIMA Critiques Dispute Policy
Novel Devices Won't Suffer, but the Others? : Lab-Test Labeling Guidelines Stir Controversy : Judge Curbs FDA Marketing Rules : Group Seeks Action against Reprocessors : HIMA Critiques Dispute Policy
Oct 1, 1999
|
11 Min Read
byJames G. Dickinson
New FDA Devices Chief Feigal: A Positive First Impression : Quality Plans Speed Audits : At High Risk for Y2K Problems
Regulatory & Quality
New FDA Devices Chief Feigal: A Positive First Impression : Quality Plans Speed Audits : At High Risk for Y2K Problems
New FDA Devices Chief Feigal: A Positive First Impression : Quality Plans Speed Audits : At High Risk for Y2K Problems
Sep 1, 1999
|
9 Min Read
FDA in 2000: A Changing Regulatory Environment
Regulatory & Quality
FDA in 2000: A Changing Regulatory Environment
FDA in 2000: A Changing Regulatory Environment
Sep 1, 1999
|
1 Min Read
byJonathan S. Kahan
Third-Party Device Reviews Beat FDA's
Regulatory & Quality
Third-Party Device Reviews Beat FDA's
Third-Party Device Reviews Beat FDA's
Aug 1, 1999
|
9 Min Read
Standard and custom shielding
Regulatory & Quality
Standard and custom shielding
Standard and custom shielding
Jul 1, 1999
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6 Min Read
FDA Action Plan to Improve Regulation of Biologic Devices
Regulatory & Quality
FDA Action Plan to Improve Regulation of Biologic Devices
FDA Action Plan to Improve Regulation of Biologic Devices
Jul 1, 1999
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10 Min Read
byJames G. Dickinson
Patient Simulators Breathe Life into Product Testing
Testing
Patient Simulators Breathe Life into Product Testing
Patient Simulators Breathe Life into Product Testing
Jun 1, 1999
|
16 Min Read
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
Jun 1, 1999
|
20 Min Read
Quality and Productivity: Then and Now
QA/QC
Quality and Productivity: Then and Now
Quality and Productivity: Then and Now
Jun 1, 1999
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6 Min Read
byChuck Truby
FDA/Industry Partnerships: Moving toward More Equitable Enforcement
Regulatory & Quality
FDA/Industry Partnerships: Moving toward More Equitable Enforcement
FDA/Industry Partnerships: Moving toward More Equitable Enforcement
May 1, 1999
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13 Min Read
From FDA Quality System Regulation to CE Marking
Regulatory & Quality
From FDA Quality System Regulation to CE Marking
From FDA Quality System Regulation to CE Marking
May 1, 1999
|
12 Min Read
Understanding FDA's Electronic Records and Signatures Regulation
Regulatory & Quality
Understanding FDA's Electronic Records and Signatures Regulation
Understanding FDA's Electronic Records and Signatures Regulation
May 1, 1999
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23 Min Read
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.
May 1, 1999
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5 Min Read
byJames G. Dickinson
A Winning Team: PDP process helps VP gain knowledge of FDA issues
Regulatory & Quality
A Winning Team: PDP process helps VP gain knowledge of FDA issues
A Winning Team: PDP process helps VP gain knowledge of FDA issues
Apr 1, 1999
|
4 Min Read
Testing and Inspection
Testing
Testing and Inspection 16113
Testing and Inspection
Apr 1, 1999
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10 Min Read
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
Mar 1, 1999
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3 Min Read
Lightening the Regulatory Burden : Does FDA's Export/Import Guidance Go Too Far? : Focus on Risk Management : In Europe, FDA
Regulatory & Quality
Lightening the Regulatory Burden : Does FDA's Export/Import Guidance Go Too Far? : Focus on Risk Management : In Europe, FDA Will Abide by FOIA : FDA Updates Consensus Standards Guidance : Old Won't Fit into New : Device Firms Need Design Control Procedu
Lightening the Regulatory Burden : Does FDA's Export/Import Guidance Go Too Far? : Focus on Risk Management : In Europe, FDA Will Abide by FOIA : FDA Updates Consensus Standards Guidance : Old Won't Fit into New : Device Firms Need Design Control Procedu
Mar 1, 1999
|
10 Min Read
byJames G. Dickinson
Susceptibility Testing Requirements for Medical Systems
Testing
Susceptibility Testing Requirements for Medical Systems
Susceptibility Testing Requirements for Medical Systems
Feb 1, 1999
|
11 Min Read
PC Interfacing for the Medical Market: Is a New Standard Emerging?
Regulatory & Quality
PC Interfacing for the Medical Market: Is a New Standard Emerging?
PC Interfacing for the Medical Market: Is a New Standard Emerging?
Feb 1, 1999
|
17 Min Read
FDA Finalizes Off-Label Dissemination Rule
Regulatory & Quality
FDA Finalizes Off-Label Dissemination Rule
FDA Finalizes Off-Label Dissemination Rule
Feb 1, 1999
|
11 Min Read
byJames G. Dickinson
FDAMA: One Year LaterAn anniversary review of the legislation
Regulatory & Quality
FDAMA: One Year LaterAn anniversary review of the legislation
FDAMA: One Year LaterAn anniversary review of the legislation
Jan 1, 1999
|
11 Min Read
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA
Regulatory & Quality
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA
Jan 1, 1999
|
3 Min Read
Device and Biologic Combination Products: Understanding the Evolving Regulation
Regulatory & Quality
Device and Biologic Combination Products: Understanding the Evolving Regulation
Device and Biologic Combination Products: Understanding the Evolving Regulation
Jan 1, 1999
|
13 Min Read
Year-End Report Notes Faster Reviews, More Changes at FDA : Device Interaction Alert : Henney Confirmation : PMA "Not
Regulatory & Quality
Year-End Report Notes Faster Reviews, More Changes at FDA : Device Interaction Alert : Henney Confirmation : PMA "Not Approvable" : Balloon Stent Alert : FDA One-Sidedness Continues : MRA Transition Delayed : CDRH Draft Inspection Handbook
Year-End Report Notes Faster Reviews, More Changes at FDA : Device Interaction Alert : Henney Confirmation : PMA "Not Approvable" : Balloon Stent Alert : FDA One-Sidedness Continues : MRA Transition Delayed : CDRH Draft Inspection Handbook
Jan 1, 1999
|
10 Min Read
byJames G. Dickinson

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