Friday, January 18, 2013
FDA: Don’t Rely On Device Labeling To ‘Design Out’ Product Risks
FDA: Don’t Rely On Device Labeling To ‘Design Out’ Product Risks-thegraysheet: Manufacturers shouldn’t make the mistake of using product labeling to mitigate device risks, according to a recent FDA draft guidance. Instead, firms should “design out” those risks to ensure that they only make quality products, an agency official says.