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

Videos | Cardiac Imaging| December 29, 2017
ITN and DAIC Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies on the
Siemens Healthineers Introduces Share360 Tailored Service Portfolio
News | Cardiac Imaging| November 10, 2017
To address the specific needs of medical imaging clinical engineering departments nationwide, Siemens Healthineers has...
HeartFlow's FFR-CT (FFRct) analysis software can create a virtual FFR to assess coronary artery disease.

HeartFlow's FFR-CT analysis software uses a computed tomography scan and supercomputing fluid dynamics software to create a noninvasive, virtual FFR map of the entire coronary artery tree to determine the flow-limiting severity of ant lesions. 

News | Cardiac Imaging| November 06, 2017
November 6, 2017 – The Centers for Medicare & Medicaid Services (CMS) has finalized a New Technology Ambulatory P
Philips Announces Findings of Patient Experience in Imaging Research
News | Cardiac Imaging| October 24, 2017
Philips recently announced the key findings of its research focused on the patient experience in diagnostic imaging...
ASNC and SNMMI Release Joint Document on Diagnosis, Treatment of Cardiac Sarcoidosis
News | Cardiac Imaging| August 18, 2017
August 18, 2017 — The American Society of...
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Videos | Cardiac Imaging| July 18, 2017
Leslee Shaw, Ph.D., director of clinical research and professor of medicine at Emory University, Atlanta, and past-pr

Physicians will need to use a CMS-certified appropriate use criteria (AUC) clinical decision support software that documents the appropriateness of an imaging order to receive full reimbursement for Medicare patients starting Jan. 1, 2018.

Feature | Cardiac Imaging| April 18, 2017 | Dave Fornell
As part of U.S. healthcare reform efforts, starting Jan.
Philips, cardiology solutions, ACC.17, Azurion angiography system, iFR outcomes results, IntelliSpace Cardiovascular
News | Cardiac Imaging| March 24, 2017
At the 2017 American College of Cardiology's Annual Scientific Session & Expo (ACC.17), Philips showcased a broad...
Siemens Healthineers, ACC 2017, syngot CTO Guidance, Compressed Sensing Cardiac Cine
News | Cardiac Imaging| March 16, 2017
During the 66th Annual Scientific Session & Expo of the American College of Cardiology (ACC), March 17-19 in...
Overlay Init