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Tag: medical device

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Read the guidance The final guidance: Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol. Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing. Provides consensus standard references and terminology to aid […]

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 […]

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) […]

FDA Web Update: How to Determine if Your Product is a Medical Device

The Center for Devices and Radiological Health (CDRH) posted new updates on FDA.gov on December 17, 2019. The How to Determine if Your Product is a Medical Device page discusses the steps when trying to determine if a product is regulated by the FDA as a medical device and include: Step 1: Determining if your product meets the […]

FDA Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

On October 16, 2019, the U.S. Food and Drug Administration (FDA) hosted a webinar to share information and answer questions about the final guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. This guidance outlines a rigorous, methodical approach for the consideration of uncertainty […]

FDA Draft Guidance: Patient Engagement in Design and Conduct of Medical Device Clinical Investigations

The U.S. Food and Drug Administration (FDA) issued the draft guidance on September 23, 2019 on Patient Engagement in Design and Conduct of Medical Device Clinical Investigations.   The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients and their family caregivers. FDA believes that these individuals can and should […]

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 […]

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