Department of Health and Human Services March 7, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
GW Cosmetics GmbH; Filing of Color Additive Petition
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds
The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds' 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection related to Reclassification Petitions for Medical Devices.
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