June 2008 Regulatory Affairs Monthly TopicPrint this page

FDA Initiates Reclassification of Full Field Digital Mammography Systems

Full field digital mammography (“FFDM”) systems, which are devices intended for the screening and diagnosis of breast cancer, are currently regulated as class III devices requiring premarket approval. However, the U.S. Food and Drug Administration (“FDA” or the “agency”) has recently initiated the downclassification of these systems to class II. This recent initiative follows a Radiological Devices Panel meeting held roughly two years ago, on May 23, 2006, during which the panel unanimously recommended that FFDM systems be reclassified to class II subject to special controls, as the panel determined that the provision of specials controls would provide reasonable assurance of the safety and effectiveness of these devices for their intended use.(1.)

FFDM systems are devices used to produce full field digital x-ray images of the breast and may include digital mammography software, a full field digital image receptor, an acquisition workstation, and signal analysis programs. (2.) FFDM systems are generally indicated for use in the same clinical applications as traditional screen-film based mammographic systems, to generate mammographic images to be use in the screening and diagnosis of breast cancer.

FFDM systems are “postamendments” devices, meaning they were not in commercial distribution prior to May 28, 1976. (3.) Indeed, these systems are relatively new devices, with the first FFDM system to gain premarket approval in January 2000. As postamendments devices, FFDM systems were automatically classified as class III without the need for FDA rulemaking and were subject to premarket approval.(4.) Under the proposed reclassification, FFDM systems will now be subject to 510(k) premarket clearance for substantially similar indications for use as the existing devices that have received premarket approval.(5.)

Reclassification of postamendments devices is governed by section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”). Under the Act, reclassification is appropriate when the proposed new class has sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.(6.) Accordingly, FDA has released a draft special controls guidance document entitled, Class II Special Controls Guidance Document: Full Field Digital Mammography System, which outlines the proposed electrical safety and physical laboratory testing requirements necessary to support a 510(k) premarket notification for an FFDM system.(7.) FDA has identified electrical hazards, corrupted or nondiagnostic images, incorrect patient positioning, excessive x-ray exposure, excessive breast compression, and infection or skin irritation as potential risks associated with FFDM systems that must be adequately addressed for the device to be cleared. The agency believes the special controls outlined in its draft guidance document, which include electrical safety testing, physical laboratory testing, clinical studies, and labeling requirements, along with general controls, are sufficient to provide reasonable assurance of the safety and effectiveness of FFDM systems.(8)

1. Reclassification of Full Field Digital Mammography System, 73 Fed. Reg. 31,042 (May 30, 2008).
2. CDRH, Class II Special Controls Guidance Document: Full Field Digital Mammography System, 5, May 30, 2008 (available at http://www.fda.gov/cdrh/ode/guidance/1616.pdf) (hereinafter Draft Guidance).
3. May 28, 1976, is the date of enactment for the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act to established the basic regulatory framework for medical devices and the classification scheme for all devices in existence at that time.
4. Reclassification of Full Field Digital Mammography System, 73 Fed. Reg. at 31,042.
5. See Draft Guidance, supra note 2.
6. Reclassification of Full Field Digital Mammography System, 73 Fed. Reg. at 31,042.
7. Draft Guidance, supra note 2.
8. Reclassification of Full Field Digital Mammography System, 73 Fed. Reg. at 31,042.