MANUFACTURER CHOICE OF DEVICE TO UNDERGO DESIGN CONTROL INSPECTION "REASONABLE APPROACH," FDAer SAYS; HIMA SETS UP WEB SITE ON DESIGN CONTROL AUDITS
This article was originally published in The Gray Sheet
A Health Industry Manufacturers Association proposal to allow manufacturers to select which of their devices will be inspected for design controls during the one-year transitional period for the requirements is "a reasonable approach," Robert Ruff, a consumer safety officer in FDA's New Jersey District Office, said at a May 30 agency/industry workshop on design controls in Baltimore.
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