All medical device manufacturers know the implications of the Class I, II and III device categories. If a device falls in the Class I category then the probable mantra is "Full steam ahead! Piece of cake!" Perhaps this "mantra" seems exaggerated but in comparison to Class II stipulations, Class I requirements do seem relatively simple.
And Class III? Class III devices—for good reason—require a PMA (Pre-Market Approval) which is not easy to obtain without significant expenditure on the part of the manufacturer. For this reason, it is significant that the FDA has redefined standard percutaneous transluminal coronary angioplasty catheters as Class II devices instead of Class III devices. As Class II devices these catheter types will still require "special controls" as reported by FDANews but will still save manufacturers thousands, hundreds of thousands and perhaps millions of dollars under the auspices of Class II requirements.
On October 8, 2010 the final rule regarding the reclassification will be officially released and regarded as effective.
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