Medical Devices; Classification of Transilluminators (Diaphanoscopes or Lightscanners) for Breast Evaluation
fda-device · Food and Drug Administration · Rule · Published 1995-07-18 · 60 FR 36639
Document
Document number
95-17640
Federal Register citation
60 FR 36639
CFR reference
21 CFR 892
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1995-07-18
HHS docket
Docket No. 94N-0345
Abstract
The Food and Drug Administration (FDA) is issuing a final rule to classify the transilluminator (diaphanoscope or lightscanner) for breast evaluation into class III (premarket approval). This action is necessary to require manufacturers of transilluminators to submit a premarket approval application that includes information concerning safety and effectiveness tests for the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.