Recently Posted FDA Guidance Documents
12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]
SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings
January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]
Real Life Film Series: The Bleeding Edge
October 15, 2019 from 12:10 PM to 1:00 PM Tompkins McCaw Library, Lecture Room 2-010 (509 N. 12th St., Richmond, Va. 23298) Students, faculty, staff and health professionals are invited to the screening of the engaging documentary, The Bleeding Edge. Look at the unforeseen consequences of advanced technological devices used in the medical field. Then join […]
Recently Posted FDA Guidance Documents
9/27/2019 – Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]
Recently Posted FDA Guidance Documents
The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 29, 2019. To view listings for other dates, see CDRH New – News and Updates. Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions This guidance document describes the Food and […]
September’s Journey to Impact presentations from the “Beyond the Bench” Workshop Series
Journey to Impact: Dr. Horn-Ranney Fri. September 6th, 12:00 – 1:00 PM Main Hospital – M2 – Room 2-125 Hear from Dr. Horn-Ranney (CEO of Tympanogen) about founding her medical device company, navigating the transition from academia, and the importance of research commercialization Journey to Impact: Dr. Eric Edwards Fri. September 20th, 12:00 – 1:00 PM Main […]