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www.fdanews.com/articles/129414-draft-infusion-pump-guidance-needs-work-devicemakers-say

Draft Infusion Pump Guidance Needs Work, Devicemakers Say

August 12, 2010
Devicemakers are questioning several parts of a draft guidance on infusion pumps that the FDA issued as part of its first classwide action, and they’re asking for more time to implement its provisions. Baxter suggests the agency delay implementing the guidance for 12 to 18 months so it can clarify the provisions that are most confusing — such as a request that manufacturers prove substantial equivalence by submitting information about their pumps via an assurance case report.
Devices & Diagnostics Letter