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Tag: HDE

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body: premarket approval applications (PMAs), humanitarian device exemption […]

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 […]

FDA Medical Device Webinars for October 2019

The FDA’s Center for Devices and Radiological Health (CDRH) hosts webinars to help educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered. Webinars scheduled for […]

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 […]

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