Department of Health and Human Services April 15, 2019 – Federal Register Recent Federal Regulation Documents
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Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
The Food and Drug Administration (FDA or we) is classifying the ventilatory electrical impedance tomograph 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 ventilatory electrical impedance tomograph's 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SYMPROIC
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SYMPROIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
The National Healthcare Safety Network's Proposed Requirement for Submission of Billing Codes as Part of Surgical Site Infection (SSI) Event Reporting; Request for Information
The Centers for Disease Control and Prevention, in the Department of Health and Human Services, announces the opening of a docket to obtain information regarding the proposed requirement for reporting of International Classification of Diseases, 10th Revision, Procedural Classification System (ICD-10-PCS) or Current Procedures Terminology (CPT) Codes (collectively, Billing Codes) when reporting data to the National Healthcare Safety Network's (NHSN) Surgical Site Infection (SSI) Module of the Patient Safety Component. CDC is opening this docket to provide the opportunity to identify challenges for facilities to include ICD-10-PCS or CPT Codes when reporting SSI data to the NHSN, which is proposed to begin in 2021.
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.
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