Medical Devices; Obstetrical and Gynecological Devices; Classification of the Breast Lesion Documentation System
Information
Type
Rule
Regulated products
Medical Devices
Published
July 28, 2003
Last updated
July 28, 2003
Description
Document number 03-19029. The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)