Little Industry Criticism On FDA Radiation Rules Rewrite
Industry response to a US FDA overhaul of performance standards for some radiation-emitting devices is largely neutral to positive, a review of comments submitted by the 1 July deadline shows.
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The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.
The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.