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James Dickinson

James G. Dickinson

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FDA Has a Bone to Pick with Small Medical Device Companies

Regulatory & Quality

FDA Has a Bone to Pick with Small Medical Device Companies FDA Has a Bone to Pick with Small Medical Device Companies

byJames G. Dickinson

Apr 3, 2012

9 Min Read

510(k) Caution Engulfs FDA—Predicate Choices Questioned

Regulatory & Quality

510(k) Caution Engulfs FDA—Predicate Choices Questioned 510(k) Caution Engulfs FDA—Predicate Choices Questioned

byJames G. Dickinson

Jun 3, 2010

11 Min Read

All from James G. Dickinson

Predictability Competes with Confidence in 510(k) Revamp

Medical Device Markets

Predictability Competes with Confidence in 510(k) Revamp

Predictability Competes with Confidence in 510(k) Revamp

byJames G. Dickinson

Shuren Seeks a “Predictably Adaptive” CDRH

Medical Device Markets

Shuren Seeks a “Predictably Adaptive” CDRH

Shuren Seeks a “Predictably Adaptive” CDRH

byJames G. Dickinson

Will FDA Be Able to Crack the Regulatory Whip on Industry?

Regulatory & Quality

Will FDA Be Able to Crack the Regulatory Whip on Industry?

Will FDA Be Able to Crack the Regulatory Whip on Industry?

byJames G. Dickinson

Endotec: Corrections and Removals

Endotec: Corrections and Removals

Endotec: Corrections and Removals

byJames G. Dickinson

When FDA Takes Its Complaints to Your Customers

Regulatory & Quality

When FDA Takes Its Complaints to Your Customers

When FDA Takes Its Complaints to Your Customers

byJames G. Dickinson

FDA Sees Dollar Signs in Battle with TMJ Implants

FDA Sees Dollar Signs in Battle with TMJ Implants

FDA Sees Dollar Signs in Battle with TMJ Implants

byJames G. Dickinson

2009: Turmoil Erupts at CDRH

Medical Device Regulations

2009: Turmoil Erupts at CDRH

2009: Turmoil Erupts at CDRH

byJames G. Dickinson

Swift and Supersized FDA Enforcement

Regulatory & Quality

Swift and Supersized FDA Enforcement

Swift and Supersized FDA Enforcement

byJames G. Dickinson

Daniel Schultz Resigns Amid CDRH Controversies

Medical Device Regulations

Daniel Schultz Resigns Amid CDRH Controversies

Daniel Schultz Resigns Amid CDRH Controversies

byJames G. Dickinson

Conflict of Interest? Hamburg Recuses Herself from Device Issue

Medical Device Regulations

Conflict of Interest? Hamburg Recuses Herself from Device Issue

Conflict of Interest? Hamburg Recuses Herself from Device Issue

byJames G. Dickinson

Hamburg Promises a Shake-Up at FDA

Regulatory & Quality

Hamburg Promises a Shake-Up at FDA

Hamburg Promises a Shake-Up at FDA

byJames G. Dickinson

CDRH Practices Finally Get Attention in 510(k) Probe

Medical Device Markets

CDRH Practices Finally Get Attention in 510(k) Probe

CDRH Practices Finally Get Attention in 510(k) Probe

byJames G. Dickinson

30 Years Later, Preemption Is Still Unsettled

Medical Device Markets

30 Years Later, Preemption Is Still Unsettled

30 Years Later, Preemption Is Still Unsettled

byJames G. Dickinson

Sweeping the House Clean at FDA

Regulatory & Quality

Sweeping the House Clean at FDA

Sweeping the House Clean at FDA

byJames G. Dickinson

Is Schultz Under the Democrats' Gun?

Is Schultz Under the Democrats' Gun?

Is Schultz Under the Democrats' Gun?

byJames G. Dickinson

Congress May Hit Device Makers with a Triple Whammy

Medical Device Markets

Congress May Hit Device Makers with a Triple Whammy

Congress May Hit Device Makers with a Triple Whammy

byJames G. Dickinson

How Does a Weapon Almost Become a Medical Device?

Medical Device Regulations

How Does a Weapon Almost Become a Medical Device?

How Does a Weapon Almost Become a Medical Device?

byJames G. Dickinson

Could New Administration Freeze Out Industry Access?

Medical Device Markets

Could New Administration Freeze Out Industry Access?

Could New Administration Freeze Out Industry Access?

byJames G. Dickinson

008: High and Low Notes for FDA Enforcers, Budgeteers

Regulatory & Quality

008: High and Low Notes for FDA Enforcers, Budgeteers

008: High and Low Notes for FDA Enforcers, Budgeteers

byJames G. Dickinson

CDRH Weaves ‘Tangled Web’ on LASIK

CDRH Weaves ‘Tangled Web’ on LASIK

CDRH Weaves ‘Tangled Web’ on LASIK

byJames G. Dickinson

Senators Pick Up Preemption Rollback

Medical Device Markets

Senators Pick Up Preemption Rollback

Senators Pick Up Preemption Rollback

byJames G. Dickinson

Does FDA Know Its Litigation Expenses?

Regulatory & Quality

Does FDA Know Its Litigation Expenses?

Does FDA Know Its Litigation Expenses?

byJames G. Dickinson

CDRH Changes Course on Dental Mercury

CDRH Changes Course on Dental Mercury

CDRH Changes Course on Dental Mercury

byJames G. Dickinson

An Honest Assessment May Boost FDA Appropriation

Regulatory & Quality

An Honest Assessment May Boost FDA Appropriation

An Honest Assessment May Boost FDA Appropriation

byJames G. Dickinson

Republicans Press FDA on Device Appeals

Regulatory & Quality

Republicans Press FDA on Device Appeals

Republicans Press FDA on Device Appeals

byJames G. Dickinson

FDA Placing Its Own Personnel in China

Regulatory & Quality

FDA Placing Its Own Personnel in China

FDA Placing Its Own Personnel in China

byJames G. Dickinson

Ignoring an Inconvenient Truth

Medical Device Markets

Ignoring an Inconvenient Truth

Ignoring an Inconvenient Truth

byJames G. Dickinson

Do FDA Chiefs Have Real Power?

Regulatory & Quality

Do FDA Chiefs Have Real Power?

Do FDA Chiefs Have Real Power?

byJames G. Dickinson

CDRH Promises Crackdown on Risky Devices

Medical Device Markets

CDRH Promises Crackdown on Risky Devices

CDRH Promises Crackdown on Risky Devices

byJames G. Dickinson

Conflicts of Interest at FDA: A Tangled Web

Regulatory & Quality

Conflicts of Interest at FDA: A Tangled Web

Conflicts of Interest at FDA: A Tangled Web

byJames G. Dickinson

007: The Year of FDA’s Transformation

Regulatory & Quality

007: The Year of FDA’s Transformation

007: The Year of FDA’s Transformation

byJames G. Dickinson

In Pursuing an ICD Case, States Outperform FDA

Regulatory & Quality

In Pursuing an ICD Case, States Outperform FDA

In Pursuing an ICD Case, States Outperform FDA

byJames G. Dickinson

CDRH Ombudsman Shows His Resolve

Medical Device Markets

CDRH Ombudsman Shows His Resolve

CDRH Ombudsman Shows His Resolve

byJames G. Dickinson

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