Department of Health and Human Services July 20, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program
This proposed rule would implement the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The purpose of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound stimulator systems for aesthetic use may comply with the requirement of special controls for class II devices. This guidance document is being immediately implemented as the special control for focused ultrasound stimulator systems for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices.
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound Stimulator System for Aesthetic Use
The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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