Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System
Information
Type
Rule
Regulated products
Medical Devices
Published
November 7, 2017
Last updated
November 7, 2017
Description
Document number 2017-24159. The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)