News | August 12, 2009

FDA Medical Device, Radiological Health Regulator Resigns

Daniel Schultz, M.D., director of the FDA Center for Devices and Radiological Health

August 12, 2009 - The Food and Drug Administration's (FDA) top medical-device regulator, Daniel Schultz, M.D., director of the FDA Center for Devices and Radiological Health, announced his resignation.

While Dr. Schultz said it was a mutual agreement with FDA Commissioner Margaret Hamburg, the decision followed internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.

Dr. Schultz has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years. However, concerns over Dr. Schultz’s decisions surfaced two years ago when Sen. Chuck Grassley (R- Iowa) held hearings on Dr. Schultz's approval of a nerve stimulation device to treat depression, irrespective of objections from multiple FDA doctors. The senator again opened an investigation into a knee-surgery device made by ReGen Biologics Inc., also approved by Dr. Schultz despite numerous objections from FDA scientists and reviewers.

A year ago, the House Energy and Commerce Committee launched an investigation into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns.

The investigation was prompted by a letter released publicly from “a large group of scientists and physicians” within the FDA's Center for Devices and Radiological Health (CDRH), dated Oct. 14, 2008, said Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) According to the statement, the letter describes CDRH managers that have “corrupted and interfered with the scientific review of medical devices.”

The statement went on to say that the committee has been “provided with compelling evidence to support the charges that senior managers within CDRH ‘ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.'”

The scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants.

For more information: www.fda.gov

Related Content

Researchers Trace Parkinson’s Damage in the Heart
News | PET Imaging | July 17, 2018
A new way to examine stress and inflammation in the heart will help Parkinson’s researchers test new therapies and...
Zebra Medical Vision Announces FDA 510(k) Clearance of Coronary Calcium Algorithm
Technology | Computed Tomography (CT) | July 12, 2018
Zebra Medical Vision has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Coronary...
HeartFlow Announces New Commercial Coverage With UnitedHealthcare
News | Computed Tomography (CT) | July 03, 2018
HeartFlow Inc. announced that UnitedHealthcare now covers the HeartFlow FFRct Analysis, extending access to their 45...
New ASNC SPECT Imaging Guideline Addresses Advances in Myocardial Perfusion Imaging
News | SPECT Imaging | June 21, 2018
The American Society of Nuclear Cardiology (ASNC) has published an update to its 2010 guidelines for single photon...
Epsilon Imaging Demonstrates Strain Imaging Integration for Echo Programs at ASE 2018
News | Cardiovascular Ultrasound | June 19, 2018
Clinical practice, along with guidelines and research, have shown that speckle tracking strain imaging can improve...
FDA Clears Bay Labs' EchoMD AutoEF Software for AI Echo Analysis
Technology | Cardiovascular Ultrasound | June 19, 2018
Cardiovascular imaging artificial intelligence (AI) company Bay Labs announced its EchoMD AutoEF software received 510(...
High Prevalence of Atherosclerosis Found in Lower Risk Patients
News | Magnetic Resonance Imaging (MRI) | June 08, 2018
Whole-body magnetic resonance angiography (MRA) found a surprisingly high prevalence of atherosclerosis in people...
FAST Study Demonstrates High Diagnostic Accuracy of CAAS vFFR
Technology | Angiography | May 22, 2018
Pie Medical Imaging announced that clinical data on its CAAS vFFR (Cardiovascular Angiographic Analysis Systems for...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
Overlay Init