Consensus Standards: FDA Guidance Describes Recognition Process
The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.
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The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
COVID-19: Newly Authorized Device From OraSure Subsidiary Allows At-Home Collection Of Saliva Samples
The device is the first that does not require a health care professional to supervise the saliva sample- collection process.
The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.