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Tag: FDA

FDA OMHHE releases new video on medical device clinical trials

FDA’s Office of Minority Health and Health Equity released a new video about the importance of diverse participation in clinical research for medical devices. The FDA not only reviews new drugs, but the agency also reviews many medical devices before they are marketed to determine if they meet FDA’s safety and effectiveness standards. Diverse participation in clinical […]

FDA adds 25 regulatory science tools to help assess medical devices

The U.S. Food and Drug Administration (FDA) added 25 tools to the Catalog of Regulatory Science Tools to help assess medical devices. The tools include: Laboratory Accuracy Evaluation of Infrared Thermographs Benchmark Problems for Verifying Cardiac Electrophysiological Models Use of Newtonian Analog Fluids And 3D Printing to Evaluate Flow Rates of Diets In G-Tubes Confocal […]

Listening Session on the Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) will host a virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence. During the session, the FDA will discuss the purpose and functions of the Center of Excellence and will focus on […]

Webinar Materials: Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway:  Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes  You […]

FDA virtual Town Hall for test developers on SARS-CoV-2

Oct. 7 from 12:15 – 1:15 p.m. On Wednesday, October 7, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for test developers for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development and validation of tests […]

FDA Launches the Digital Health Center of Excellence

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and […]

Recently Posted FDA Guidance Documents

9/25/2020 – Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 9/25/2020 – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation […]

FDA Grand Rounds – October 8, 2020

CE Credit Available Presented by:Sam Raney, PhDLead for Topical and Transdermal Drug ProductsOffice of Generic Drugs, CDER, FDA About the Presentation:This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics. These […]

Recently Posted FDA Guidance Document

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Link: www.fda.gov/media/142143/download

FDA OMHHE’s Clinical Trial Diversity free webinar

Tuesday, September 22 from 1:00 – 2:00 p.m. The FDA Office of Minority Health and Health Equity (OMHHE) at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck). Drs. Bierer […]

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