Department of Health and Human Services September 27, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.'' This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software.
Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical Decision Support Software.'' This guidance clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). This guidance describes a risk-based approach for regulatory oversight of CDS software functions that remain devices using the categories defined by the International Medical Device Regulators Forum (IMDRF) final document entitled ``Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.'' The guidance also provides clarity on the types of CDS software functions on which FDA intends to focus its regulatory oversight for health care providers, patients, and caregivers. This draft guidance is not final nor is it in effect at this time.
Announcement of the Intent To Award an Emergency Single-Source Grant
The ACF, ANA, Division of Program Operations (DPO) intends to award a grant of $106,638 to 500 Sails, Inc. in Saipan, Commonwealth of the Northern Mariana Islands. The purpose of the award is to support restoration of culturally significant sites and a digital storytelling project after the devastating effects of Typhoon Yutu in October, 2018.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Prospective Grant of Exclusive Patent License: Capsid-Free AAV Vectors, Compositions, and Methods for Vector Production and Gene Delivery
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Generation Bio Co. (``Generation Bio''), a company based in Cambridge, Massachusetts (in the exclusive field specified below), and a co- exclusive license to Generation Bio and Spark Therapeutics, a company based in Philadelphia, Pennsylvania (in the co-exclusive field specified below), to practice the inventions embodied in the patent application listed in the Supplementary Information section of this notice.
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