# Medical Devices; Obstetrical and Gynecological Devices; Classification of the Breast Lesion Documentation System
> **Food and Drug Administration** · Final rule. · Published 2003-07-28 · Effective 2003-08-27 · 68 FR 44414
## Document
- **Document number:** 03-19029
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 44414
- **CFR reference:** 21 CFR 884
- **Publication date:** 2003-07-28
- **Effective date:** 2003-08-27
- **HHS docket:** Docket No. 2003P-0301
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/07/28/03-19029/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-breast-lesion)
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