Department of Health and Human Services February 7, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling 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: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact cooling systems for aesthetic use may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify contact cooling systems for aesthetic use into class II (special controls). The guidance document is immediately in effect as the special control for cooling system for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices (GGPs).
Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use
The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use Powder; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder.'' This draft guidance document provides a recommended warning statement related to medical gloves that contain powder or use donning or dusting powder, specifically surgeon's gloves and patient examination gloves (medical gloves that use powder). FDA is concerned about the potential adverse health effects from the use of powder on medical gloves and is recommending that the labeling for powdered medical gloves provide a warning related to the potential health effects. This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is announcing the establishment of a public docket to receive comments related to surgeon's gloves and patient examination gloves that contain or use donning or dusting powder.
Information Related to Risks and Benefits of Powdered Gloves; Request for Comments
The Food and Drug Administration (FDA) is announcing the establishment of a public docket to receive comments related to surgeon's gloves and patient examination gloves (medical gloves) that contain or use donning or dusting powder. FDA is interested in the potential health effects from the use of powder on medical gloves and is soliciting comments regarding risks and benefits of powdered gloves. FDA is interested in any potential benefits of powdered gloves so that the Agency can consider how best to address the risks in light of any benefits. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for a draft guidance document entitled ``Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use Powder.'' The draft guidance document provides a recommended warning statement for powdered glove labeling that will inform health care providers and consumers of the risks associated with glove powder.
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