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 | Breast Imaging

Sept. 10, 2026 — An artificial intelligence model that analyzes women's past and recent annual 3D mammograms is more ...

Time September 10, 2026
arrow
Feature | Artificial Intelligence | Kyle Hardner

A radiologist pulls up a chest CT scan flagged for a pulmonary nodule. One artificial intelligence (AI) tool writes its ...

Time September 09, 2026
arrow
News | Nuclear Imaging

Sept. 08, 2026 — GE HealthCare has announced that StarGuide GX1, its digital 4D CZT SPECT/CT technology, is 510(k) ...

Time September 09, 2026
arrow
News | Ultrasound Women's Health

Sept. 3, 2026 — Royal Philips has introduced the eV14-2v transvaginal transducer, expanding its obstetrics and ...

Time September 04, 2026
arrow
News | Women's Health

Sept. 1, 2026 — On Sept. 24, 2026 at 1 p.m. EDT, Siemens Healthineers will present a webinar on "Advancing Women's ...

Time September 03, 2026
arrow
News | Radiology Business

August 18, 2026 – NewVue, a provider of cloud-native software that unifies how radiologists work while improving ...

Time August 25, 2026
arrow
Feature | Artificial Intelligence | Madhu Jahagirdar

Radiologists spend much of their day moving between different systems: One application to review images. Another to ...

Time August 17, 2026
arrow
News | X-Ray

Aug. 10, 2026 — Teledyne Technologies Inc. and Varex Imaging Corp. have jointly announced that they have entered into a ...

Time August 14, 2026
arrow
News | Breast Imaging

Aug. 13, 2026 – Perimeter Medical Imaging AI recently announced that Intermountain Health, the largest nonprofit health ...

Time August 14, 2026
arrow
News | FDA

Aug. 1, 2026 — Candelis recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

Time August 13, 2026
arrow
Subscribe Now