I would have thought the FDA impervious to such things as vacations, particularly given the increased size of the staff at CDRH now. Devices are big time, all world now. Apple and Microsoft don't take time off from vacations! There are tens of millions of Americans suffering chronic pain 24/7, including weekends and vacations, and tens of millions more doping the pain with harmful chemicals. Those issues should raise the bar beyond vacation inertia on something that really must happen quickly and that the FDA seems to have already decided upon. The Administration assumed the clear lead with its Proposed Order last February and I suspect is well aware of what it needs to do to retain the lead and the respect of the device community, now that they have it. Compare the time of this Order with getting a drug approved.
Now, it's just a question of gettin 'er done, fish or cut bait, pull the pickle, get the lead out, or however we want to put it.
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