SECTION XII. Proposed Effective Date FDA is proposing that any final order based on this proposed order become effective on the date of its publication in the Federal Register or at a later date if stated in the final order. FDA proposes that nonthermal SWT devices must comply with the special controls and must submit a 510(k) within 60 days after the effective date of the final order. FDA requests comment on whether 60 days is an appropriate time to allow manufacturers to prepare and submit 510(k)'s for these devices.
I know that someone has already probably posted this, but tvis is what Andy has to do very soon, once the FDA finishes the new proposed order, Andy must "submit a 501(k) within 60 days after the effective date of the final order." I may not understand all this mumbo jumbo FDA talk, but it looks like the company better have ALL their ducks in a row this time because once they file and if the FDA gives them more "homework" they can have a speedy answer (within the 60 day time limit), or it will be Groundhog Day all over again, Andy better have all his Groundhogs in a row before filing. (If I understand this Section XII correctly). IMO
(Speedy 501k vs Speedy Trial - the choice is up to them)
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