Navigation Links
FDA Reclassifies Certain Digital Mammography Devices

SILVER SPRING, Md., Nov. 4, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.



These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.

When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.

Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well-described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or 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.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk among devices and include such products as heart valves and orthopedic implants. Companies must typically submit a premarket approval application for a Class III device, which requires proof of safety and effectiveness before the product can be approved for marketing. Many Class III devices involve new technology that has not been widely used.

Class I and Class II devices pose lower risk and include adhesive bandages, wheelchairs, and many medical imaging technologies, such as MRI scanners and screen-film X-ray mammography. Class II devices require submission of a premarket notification, also known as a 510(k), to establish that the product is substantially equivalent to a device already on the market.

Along with the digital mammography reclassification, the FDA is releasing a "special controls" guidance for industry that describes what evidence will be needed to show substantial equivalence for these systems, including technical device specifications, images of standard test objects, and a sample set of patient images.

The FDA has approved five full field digital mammography systems since 2000, all were approved as Class III devices. About 70 percent of the mammography units in use are digital and 70 percent of certified U.S. mammography facilities have at least one digital unit, according to FDA reports from certified mammography facilities.

In May 2006, the FDA publicly discussed plans to reclassify FFD mammography systems from Class III to Class II at a Radiology Devices Panel meeting. After the positive response from the panel, the FDA published draft guidance for public comment in May 2008. The panel held another public meeting in November 2009 to discuss the comments received on the draft guidance.

Other than skin cancer, breast cancer is the most common type of cancer among women in the United States. An estimated 207,100 new cases of breast cancer in women will be diagnosed in 2010, according to the National Cancer Institute.

For more information:

Federal Register Notice


Special Controls Guidance

Visit the FDA on Facebook and Flickr

RSS Feed for FDA News Releases [what is RSS?]

Media Inquiries: Dick Thompson, 301-796-7566,  

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Presented at 2007 ASH Meeting Demonstrate Activity of Forodesine HCl as a Single Agent or in Combination With Bendamustine in Certain Types of Leukemia and Lymphoma
2. Foamix and Galderma to Develop Medicated Foam for Certain Skin Diseases
3. St. Jude Finds Young Age May Give Survival Advantage to Children With Certain Brain Tumors
4. New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes
5. St. Jude Identifies Genomic Causes of a Certain Type of Leukemia Relapse
6. CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
7. Christie Cookie Recalls Certain Lots of Peanut Butter Cookie Dough Due to Expanded Recall by Peanut Corporation of America
8. Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey Women at Risk
9. Trauma 411: Prolonged Surgery Should be Avoided in Certain Cases
10. FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
11. Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
Post Your Comments:
(Date:11/30/2015)... 1, 2015 Express Scripts (NASDAQ: ESRX ) ... IMMY ) to drive access to a low-cost alternative to ... toxoplasmosis that has been recently priced out of reach for ... systems. --> --> Imprimis ... (a form of folic acid) for $1 per capsule for people ...
(Date:11/30/2015)... 2015 Die MEDTEC Japan ... für Entwicklung und Herstellung medizinischer Geräte, ... 2016 in Tokyo ... Foto:- Foto: ... Logo: --> ...
(Date:11/30/2015)... , December 1, 2015 ... adds "Endometriosis - Pipeline Review, H2 ... overview on therapeutic pipeline of Endometriosis and ... effective counter strategies to gain competitive advantage. ... targets and MOAs to produce first-in-class and ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... 2015 , ... The National Association of Professional Women (NAPW) honors ... Year Circle. She is recognized with this prestigious distinction for leadership in estate sales ... more than 850,000 members and over 200 operating Local Chapters. , “I’m pleased to ...
(Date:11/30/2015)... ... December 01, 2015 , ... Live ... offer individual vision insurance plans on . The multi-carrier insurance exchange ... and review products, allowing consumers to compare, quote and match plans to meet ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ... (Meso Foundation) released information for caregivers and held two webinars on topics of ... on demand free of charge at . , With a loved ...
(Date:11/30/2015)... ... November 30, 2015 , ... Thermi™, a ... to announce that its ThermiRFR temperature controlled radiofrequency platform has received CE marking ... radiofrequency platform which uses temperature as a clinical endpoint. The technology has ...
(Date:11/30/2015)... Fla. (PRWEB) , ... November 30, 2015 , ... ... opened the driverless vehicle experience this summer, ushering in a new era of ... percent driverless and electric shuttle, will continue to offer guests an up-close look ...
Breaking Medicine News(10 mins):