Device Standards Program Seeks More Input From Industry, Standards Groups
This article was originally published in The Silver Sheet
FDA's MEDICAL DEVICE STANDARDS PROGRAM will involve more partnering with industry and standards development organizations in order to encourage greater use of standards in premarket applications. The device center recently unveiled new operating procedures for prioritizing standards as well as a list of top items for collaboration with standards groups. Industry representatives cite problems with declaring conformance to standards and lack of support form corporate upper management as the chief reasons standards use is not more widespread. [A discussion on integrating standards into the design process by J&J standards expert Mike Schmidt is included.]
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