FDA to Exempt Several Unclassified Medical Devices from Premarket Notification
New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
Tag: guidance
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US and Global Agencies Release ‘Shared Vision’ of Software Bill of Materials for Cybersecurity
The guidance promotes the use of a Software Bill of Materials to increase transparency in the software supply chain, impacting medical device security and vulnerability management.
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AAMI TIR48 Offers Guidance on Combination Products
AAMI TIR48 provides guidance for manufacturers of combination products to comply with FDA CGMP regulations.
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FDA to Exempt Several Unclassified Medical Devices from Premarket Notification
New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.