News | November 04, 2010

FDA Reclassifies Certain Digital Mammography Devices

November 4, 2010 - The U.S. Food and Drug Administration (FDA) is easing the path to market for mammography systems that produce computerized X-ray images of the entire breast. Those devices will now be included in class II.

These systems, known as full field digital (FFD) mammography systems, are an alternative to mammography systems that produce X-ray film.

When first approved by the FDA in 2000, digital mammography systems were categorized as a high-risk, or class III, device. Since then, they have been well validated by studies and the benefits and risks have been well described to physicians. Class II includes medium-risk devices.

“Our decision to reclassify these devices is consistent with feedback we’ve received from public discussions with appropriate medical and scientific experts as well as our stronger understanding of how these systems work,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Companies must typically submit a pre-market approval application for a class III device, which requires proof of safety and effectiveness. Many class III devices involve new technology that has not been widely used.

Class I and class II devices pose lower risk. Class II devices require submission of a pre-market notification, or 510(k), to establish that it is substantially equivalent to a device already on the market.

For more information: www.fda.gov

Related Content

The MOZART Supra Specimen Tomosynthesis System is the latest generation of 3-D imaging for breast cancer surgery.
News | Breast Imaging | November 08, 2018
KUBTEC announced the launch of a new innovation in the treatment of breast cancer. The Mozart Supra Specimen...
Proton Therapy for Pediatric Brain Tumors Has Favorable Cognitive Outcomes
News | Proton Therapy | November 06, 2018
Proton therapy treatment for pediatric brain tumor patients is associated with better neurocognitive outcomes compared...
Deaconess Health System Chooses Sectra as Enterprise Imaging Vendor
News | Enterprise Imaging | November 02, 2018
International medical imaging information technology (IT) and cybersecurity company Sectra will install its enterprise...
150-Year-Old Drug Might Improve Radiation Therapy for Cancer
News | Radiation Therapy | November 02, 2018
November 2, 2018 — A drug first identified 150 years ago and used as a smooth-muscle relaxant might make tumors more
SBRT Considered Safe Treatment Option for Patients With Multiple Metastases
News | Stereotactic Body Radiation Therapy (SBRT) | November 01, 2018
The NRG Oncology clinical trial BR001 tested the hypothesis that stereotactic body radiotherapy (SBRT) could be used...
Hypofractionated Radiation Provides Same Prostate Cancer Outcomes as Conventional Radiation
News | Intensity Modulated Radiation Therapy (IMRT) | October 31, 2018
An analysis led by researchers at Philadelphia’s Fox Chase Cancer Center found treating localized prostate cancer with...
Volpara Enterprise Cloud Reaches 1 Million Mammograms Stored
News | Mammography | October 31, 2018
Volpara Solutions announced that the data stored in the Volpara Enterprise cloud now exceeds 1 million mammographic...
Prostate Brachytherapy Shows Low Incidence of Short-Term Complications
News | Brachytherapy Systems | October 31, 2018
A new analysis of nearly 600 men receiving brachytherapy for prostate cancer shows overall procedure-related...