When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation. The licenses that you have purchased are maintained in a centralized database called the Cisco Smart Software Manager (CSSM). The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. Smart LicensingMonitor ISE software licenses and endpoint license consumption easily and efficiently with a single token registration. Comments can be submitted to the docket for consideration by the FDA. The draft guidance explains that there are certain class I devices considered consumer health products for which the FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements under 21 CFR 830.300. This draft guidance is not for implementation at this time. ![]() On October 13, 2021, the FDA issued the draft guidance: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.
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