Department of Health and Human Services July 3, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments
The Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2008. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority- setting process.
Medical Devices; Cardiovascular Devices; Denial of Request for Change in Classification of Impedance Plethysmograph
The Food and Drug Administration (FDA) is denying the petition submitted by Life Measurements Inc., to reclassify the SONAMET Body Composition Analyzers (BOD POD and PEA POD) from class II to class I. The agency is denying the petition because Life Measurements Inc., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This notice also summarizes the basis for the agency's decision.
Neurological Devices; Denial of Request for Change in Classification of Cutaneous Electrode
The Food and Drug Administration (FDA) is denying the petition submitted by Scientific Laboratory Products LTD., to reclassify electroencephalogram (EEG) electrodes from class II to class I. The agency is denying the petition because the Scientific Laboratory Products LTD., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This document also summarizes the basis for the agency's decision.
Intent To Develop Two Interaction Profiles
This notice announces the intent of ATSDR to develop two interaction profiles.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device
The Food and Drug Administration (FDA) is proposing to reclassify the device, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses would remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This draft guidance document describes a means by which the tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify tissue adhesive for the topical approximation of skin from class III into class II (special controls). This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.'' Since FDA began accepting new drug application (NDA) and biologics license application (BLA) submissions in the common technical document (CTD) format, there has been much confusion regarding where within the CTD to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants on where to place the ISE and ISS in the CTD. This guidance addresses specific FDA requirements not discussed in the ICH guidance for industry M4E: The CTDEfficacy. This guidance is intended to improve application quality and consistency.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.'' This guidance document describes a means by which filtering facepiece respirators for use by the general public in public health medical emergencies 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 the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). This guidance document is immediately in effect as a special control for the filtering facepiece respirator for use by the general public in public health medical emergencies, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies
The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.'' This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.
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