Author: Mary LeGraw

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New FDA Guidance for Medical Device Reporting for Manufacturers

On November 8, 2016, the FDA issued the long awaited final guidance, “Medical Device Reporting for Manufacturers.”  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm359566.pdf  The final guidance addresses medical device reporting and recordkeeping requirements for device-related adverse events and certain types of device malfunctions.  The guidance supersedes the…

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