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.
A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.
The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.