FDA recently reopened comments on this Proposed Rule, which it apparently first announced in 2017. At the time, it said it would implement the guidance without prior public comment because it had determined that prior public participation was not feasible or appropriate, given that the "guidance presents a less burdensome policy that is consistent with public health."
Comments are due by midnight tonight.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------