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Device manufacturer Boston Scientific told the Food and Drug Administration that major changes are needed to a draft guidance that tries to clarify for industry when a potential change to a device is a recall and to distinguish those instances from product enhancements. In written comments submitted ahead of the May 23 deadline, Boston Scientific told FDA that while it appreciated the agency’s effort in publishing the guidance, there were many areas where it falls short. In addition, a key device trade group said in its comments that FDA should pull the draft and start again. “Having a framework that the agency and industry can leverage to distinguish between recalls and enhancements will help ensure timely recalls when a recall is necessary, and avoid confusion or disagreement when one is not,” Boston Scientific told FDA.
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