Jim Dickinson

Jim Dickinson

Latest from Jim Dickinson

FDA's Old Guard Fades Away in Enforcement Shakeup
Regulatory & Quality
FDA's Old Guard Fades Away in Enforcement ShakeupFDA's Old Guard Fades Away in Enforcement Shakeup
byJim Dickinson
Oct 11, 2013
5 Min Read
Melinda Plaisier is FDA's new Top Cop logo in a gray background |
Regulatory & Quality
Melinda Plaisier is FDA's new Top CopMelinda Plaisier is FDA's new Top Cop
byJim Dickinson
Oct 8, 2013
1 Min Read

All from Jim Dickinson

FDA LASIK Studies Delayed by 'War Efforts' logo in a gray background | FDA LASIK Studies Delayed by 'War Efforts'
Regulatory & Quality
FDA LASIK Studies Delayed by 'War Efforts'
FDA LASIK Studies Delayed by 'War Efforts'
Oct 7, 2013
|
1 Min Read
byJim Dickinson
FDA Foreign Inspections On the Rise logo in a gray background | FDA Foreign Inspections On the Rise
Business
FDA Foreign Inspections On the Rise
FDA Foreign Inspections On the Rise
Sep 12, 2013
|
1 Min Read
byJim Dickinson
Whatever Became of that LDT Regulation? logo in a gray background | Whatever Became of that LDT Regulation?
Regulatory & Quality
Whatever Became of that LDT Regulation?
Whatever Became of that LDT Regulation?
Aug 19, 2013
|
1 Min Read
byJim Dickinson
Shuren: Review Times Falling, May Get Even Faster
Regulatory & Quality
Shuren: Review Times Falling, May Get Even Faster
Shuren: Review Times Falling, May Get Even Faster
Aug 16, 2013
|
2 Min Read
byJim Dickinson
CDRH Ombudsmen Get Warm and Fuzzy on Resolution for ‘Significant Decision’ Disputes logo in a gray background | CDRH Ombudsmen Get Warm and Fuzzy on Resolution for ‘Significant Decision’ Disputes
Regulatory & Quality
CDRH Ombudsmen Get Warm and Fuzzy on Resolution for ‘Significant Decision’ Disputes
CDRH Ombudsmen Get Warm and Fuzzy on Resolution for ‘Significant Decision’ Disputes
Aug 16, 2013
|
1 Min Read
byJim Dickinson
FDA’s Device Program Really is in Crisis
Regulatory & Quality
FDA’s Device Program Really is in Crisis
FDA’s Device Program Really is in Crisis
Aug 14, 2013
|
3 Min Read
byJim Dickinson
Study Shows Layperson Defibrillator Incidents a Low Risk logo in a gray background | Study Shows Layperson Defibrillator Incidents a Low Risk
Regulatory & Quality
Study Shows Layperson Defibrillator Incidents a Low Risk
Study Shows Layperson Defibrillator Incidents a Low Risk
Jul 23, 2013
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1 Min Read
byJim Dickinson
Old Synthes Case Still Resonates as a ‘Misbehavior’ Deterrence, says Office of Criminal Investigation logo in a gray background | Old Synthes Case Still Resonates as a ‘Misbehavior’ Deterrence, says Office of Criminal Investigation
Regulatory & Quality
Old Synthes Case Still Resonates as a ‘Misbehavior’ Deterrence, says Office of Criminal Investigation
Old Synthes Case Still Resonates as a ‘Misbehavior’ Deterrence, says Office of Criminal Investigation
Jul 18, 2013
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1 Min Read
byJim Dickinson
AdvaMed Says FDA Should Stick with 1997 Guidance for 510(k) Changes logo in a gray background | AdvaMed Says FDA Should Stick with 1997 Guidance for 510(k) Changes
Regulatory & Quality
AdvaMed Says FDA Should Stick with 1997 Guidance for 510(k) Changes
AdvaMed Says FDA Should Stick with 1997 Guidance for 510(k) Changes
Jul 18, 2013
|
3 Min Read
byJim Dickinson
FDA Asked Not to Regulate Lab Tests as Devices logo in a gray background | FDA Asked Not to Regulate Lab Tests as Devices
Regulatory & Quality
FDA Asked Not to Regulate Lab Tests as Devices
FDA Asked Not to Regulate Lab Tests as Devices
Jul 16, 2013
|
1 Min Read
byJim Dickinson
House Committee Mark Up Gives FDA $100 Million Boost logo in a gray background | House Committee Mark Up Gives FDA $100 Million Boost
Regulatory & Quality
House Committee Mark Up Gives FDA $100 Million Boost
House Committee Mark Up Gives FDA $100 Million Boost
Jul 12, 2013
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1 Min Read
byJim Dickinson
FDA Warns Device Makers on Cyber Attack Risks logo in a gray background | FDA Warns Device Makers on Cyber Attack Risks
Regulatory & Quality
FDA Warns Device Makers on Cyber Attack Risks
FDA Warns Device Makers on Cyber Attack Risks
Jul 10, 2013
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3 Min Read
byJim Dickinson
FDA Sees “Extraordinary” Interest in Human Factors Guidance logo in a gray background | FDA Sees “Extraordinary” Interest in Human Factors Guidance
Regulatory & Quality
FDA Sees “Extraordinary” Interest in Human Factors Guidance
FDA Sees “Extraordinary” Interest in Human Factors Guidance
Jun 14, 2013
|
5 Min Read
byJim Dickinson
Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA logo in a gray background | Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA
Regulatory & Quality
Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA
Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA
Apr 17, 2013
|
6 Min Read
byJim Dickinson
Orthofix VP Jailed for Paying Kickbacks logo in a gray background | Orthofix VP Jailed for Paying Kickbacks
Orthopedic
Orthofix VP Jailed for Paying Kickbacks
Orthofix VP Jailed for Paying Kickbacks
Apr 5, 2013
|
2 Min Read
byJim Dickinson
Stryker Sees Double Trouble from FDA logo in a gray background | Stryker Sees Double Trouble from FDA
Regulatory & Quality
Stryker Sees Double Trouble from FDA
Stryker Sees Double Trouble from FDA
Apr 3, 2013
|
4 Min Read
byJim Dickinson
CDRH Ombudsman Justifies Existence in Annual Report
Business
CDRH Ombudsman Justifies Existence in Annual Report
CDRH Ombudsman Justifies Existence in Annual Report
Apr 3, 2013
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2 Min Read
byJim Dickinson
Does Your Medical Device Really Need to be in Class III?
Regulatory & Quality
Does Your Medical Device Really Need to be in Class III?
Does Your Medical Device Really Need to be in Class III?
Mar 26, 2013
|
9 Min Read
byJim Dickinson
Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws logo in a gray background | Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws
R&D
Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws
Researchers Say DePuy Hip Ancestry Shows 510(k) Flaws
Feb 19, 2013
|
2 Min Read
byJim Dickinson
Orthofix Manager Sentenced in Health Fraud Case logo in a gray background | Orthofix Manager Sentenced in Health Fraud Case
Orthopedic
Orthofix Manager Sentenced in Health Fraud Case
Orthofix Manager Sentenced in Health Fraud Case
Feb 19, 2013
|
1 Min Read
byJim Dickinson
Invacare Signs FDA Consent Decree logo in a gray background | Invacare Signs FDA Consent Decree
Regulatory & Quality
Invacare Signs FDA Consent Decree
Invacare Signs FDA Consent Decree
Jan 31, 2013
|
1 Min Read
byJim Dickinson
FDA to Require PMA for Two Metal-on-Metal Hip Replacements logo in a gray background | FDA to Require PMA for Two Metal-on-Metal Hip Replacements
Regulatory & Quality
FDA to Require PMA for Two Metal-on-Metal Hip Replacements
FDA to Require PMA for Two Metal-on-Metal Hip Replacements
Jan 31, 2013
|
2 Min Read
byJim Dickinson
St. Jude Medical Warned About GMPs logo in a gray background | St. Jude Medical Warned About GMPs
Regulatory & Quality
St. Jude Medical Warned About GMPs
St. Jude Medical Warned About GMPs
Jan 31, 2013
|
1 Min Read
byJim Dickinson
Israeli Device Firm Cited for Illegal Marketing logo in a gray background | Israeli Device Firm Cited for Illegal Marketing
Regulatory & Quality
Israeli Device Firm Cited for Illegal Marketing
Israeli Device Firm Cited for Illegal Marketing
Jan 31, 2013
|
1 Min Read
byJim Dickinson
CDRH Roars in January
Regulatory & Quality
CDRH Roars in January
CDRH Roars in January
Jan 31, 2013
|
1 Min Read
byJim Dickinson
Medical Device Labeling: CDRH Plans Drug-like Labels for Devices logo in a gray background | Medical Device Labeling: CDRH Plans Drug-like Labels for Devices
Packaging
Medical Device Labeling: CDRH Plans Drug-like Labels for Devices
Medical Device Labeling: CDRH Plans Drug-like Labels for Devices
Jan 30, 2013
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1 Min Read
byJim Dickinson
CDRH Answers Slowness Critics on Patient Blog logo in a gray background | CDRH Answers Slowness Critics on Patient Blog
Regulatory & Quality
CDRH Answers Slowness Critics on Patient Blog
CDRH Answers Slowness Critics on Patient Blog
Jan 22, 2013
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2 Min Read
byJim Dickinson
FDA-Industry Consortium to Speed Device Reviews logo in a gray background | FDA-Industry Consortium to Speed Device Reviews
Regulatory & Quality
FDA-Industry Consortium to Speed Device Reviews
FDA-Industry Consortium to Speed Device Reviews
Jan 17, 2013
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2 Min Read
byJim Dickinson
Comments Mostly Support FDA on Unique Device Identifier logo in a gray background | Comments Mostly Support FDA on Unique Device Identifier
Packaging
Comments Mostly Support FDA on Unique Device Identifier
Comments Mostly Support FDA on Unique Device Identifier
Dec 11, 2012
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6 Min Read
byJim Dickinson
Senate Probe Questions Medtronic Payments to MDs logo in a gray background | Senate Probe Questions Medtronic Payments to MDs
Medical Device Markets
Senate Probe Questions Medtronic Payments to MDs
Senate Probe Questions Medtronic Payments to MDs
Dec 11, 2012
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2 Min Read
byJim Dickinson
FDA Whistleblowers Lose Document ‘Discovery’ logo in a gray background | FDA Whistleblowers Lose Document ‘Discovery’
Regulatory & Quality
FDA Whistleblowers Lose Document ‘Discovery’
FDA Whistleblowers Lose Document ‘Discovery’
Dec 11, 2012
|
1 Min Read
byJim Dickinson
Obama’s Legacy: A Tougher FDA and the Device Tax
Regulatory & Quality
Obama’s Legacy: A Tougher FDA and the Device Tax
Obama’s Legacy: A Tougher FDA and the Device Tax
Dec 8, 2012
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3 Min Read
byJim Dickinson
Guidance on Mobile Medical Apps Near logo in a gray background | Guidance on Mobile Medical Apps Near
Digital Health
Guidance on Mobile Medical Apps Near
Guidance on Mobile Medical Apps Near
Nov 6, 2012
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2 Min Read
byJim Dickinson

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