Ralph Tyler is the FDA's chief counsel.


March 31, 2010 - Federal investigators found no evidence supporting charges by several doctors and scientists working for the U.S. Food and Drug Administration (FDA) that managers retaliated against them for not approving certain medical devices.

The employees also alleged managers "ordered, intimidated and coerced" the scientists to manipulate data during product reviews, particularly within the Center for Devices and Radiological Health (CDRH). They also said approvals were not documented appropriately, and that decisions were influenced by the industry or politicians.

In 2008 and 2009, a group of FDA doctors and scientists wrote to Congress complaining their jobs were affected after they had raised their concerns. They spoke publicly about overuse of radiological devices in treatment and testing, and said that use of some imaging machines poses the possibility of dangerously high doses of radiation for patients.

In a letter sent in October of 2008 to the House Energy and Commerce Committee Under, the whistleblowers said "managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions, that are not scientifically proven and clinically validated."

A report issued on January 15, 2009 by the Government Accountability Office (GAO), the investigative arm of Congress responsible for enhancing the performance of all federal government agencies, concludes that the FDA has approved many medical devices that have never been shown to be safe or effective. The GAO report advises that immediate steps be taken to modify the review policy for medical devices defined as "higher risk."

For more information: energycommerce.house.gov/


Related Content

News | Radiology Business

April 24, 2026 — The 2026 vacancy rate for radiation therapists decreased to 11.4% and the vacancy rate for medical ...

Time April 24, 2026
arrow
News | Artificial Intelligence

April 20, 2026 — DeepTek, provider of the Augmento platform and deepc, the company behind deepcOS, have introduced a ...

Time April 23, 2026
arrow
News | Breast Imaging

April 15, 2026 — QT Imaging Holdings, Inc. has launched its QTI Imaging-Olea Viewer, developed in collaboration with ...

Time April 15, 2026
arrow
News | X-Ray

April 14, 2026 — KA Imaging is seeing continued adoption of its X-ray technology across new regions, with recent ...

Time April 15, 2026
arrow
News | Ultrasound Imaging

April 9, 2026 — GE HealthCare has announced a digital integration between the GE HealthCare bkActiv intraoperative ...

Time April 09, 2026
arrow
News | SNMMI

The Society of Nuclear Medicine and Molecular Imaging's (SNMMI) 2026 Annual Meeting will take place May 30–June 2 in Los ...

Time April 07, 2026
arrow
News | PET Imaging

March 25, 2026 — Catalyst MedTech, a provider of nuclear medicine and molecular imaging solutions, has announced it is ...

Time April 06, 2026
arrow
News | Teleradiology

April 1, 2026 — Premier Radiology Services has acquired Global Imaging Solutions (GLOBIS), a leading teleradiology group ...

Time April 03, 2026
arrow
News | Breast Imaging

April 1, 2026 — QT Imaging Holdings has released its latest image reconstruction software update, version 4.5.0. This ...

Time April 02, 2026
arrow
News | Ultrasound Imaging

March 30, 2026 — Butterfly Network, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for a ...

Time April 01, 2026
arrow
Subscribe Now