Division of Clinical Research

Office of the Vice President and Innovation

Category results for: FDA Guidance

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 […]

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 […]

Oct. 21: Webinar – Humanitarian Device Exemption Program

Date: October 21, 2019 Time: 12:00 PM EDT-01:30 PM EDT Registration is not necessary. On Monday, October 21, 2019, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Humanitarian Device Exemption Program Final Guidance published on September 5, 2019 This final guidance describes how the FDA determines whether […]

Recently Posted FDA Guidance Documents

9/6/2019 – Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions […]

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 […]

Recently Posted FDA Guidance Documents

8/7/2019 – Fabry Disease: Developing Drugs for Treatment Guidance for Industry [DRAFT] Issued by: Center for Drug Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that can support the approval of drugs and biological products intended for the treatment of Fabry disease (FD). 7/31/2019 […]

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