Devicemakers balk at FDA's recall guidelines

The FDA has drafted new guidelines that would define when a device recall is necessary, but players in the industry--Boston Scientific ($BSX) and Merck ($MRK) in particular--have declared the action isn't quite enough. The agency's draft guidance, announced in February, strives to clarify the difference between a recall and a product enhancement, but Boston Scientific found "inconsistencies and oddities" in the language that leave the issue unsettled, the company noted. AdvaMed joined the fray, as well, asking that the FDA withdraw the draft for similar reasons. More from Bloomberg

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