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Tag: 510(k)

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.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 […]

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 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 […]

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