Department of Health and Human Services July 27, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
Supplemental Evidence and Data Request on Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Implementation of TeamSTEPPS in Primary Care Settings (ITS- PC).'' This proposed information collection was previously published in the Federal Register on May 5, 2017 and allowed 60 days for public comment. No substantive comments were received.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The AHRQ Safety Program for Improving Antibiotic Use.'' This proposed information collection was previously published in the Federal Register on May 5, 2017, and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
Office of the Commissioner; Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration (FDA), Office of the Medical Products and Tobacco (OMPT), has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on December 22, 2016, and became effective on that date.
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