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MDMA Submits Comments on FDA Draft Guidance

Monday, August 11, 2014  
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MDMA Submits Comments on FDA Draft Guidance

MDMA submitted comments today on the Food and Drug Administration's (FDA) draft guidance entitled, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. MDMA's comments noted particular concern over the reversal of FDA's policy toward the use of promissory statements proposed in the draft guidance, which has the potential to adversely impact small manufacturers most severely. Our comment letter can be viewed in its entirety by clicking here.