Zdrowie i gospodarka · 04/01/2016

FDA Announces Availability of Draft Guidance on Unique Device Identification Convenience Kits

The Food and Drug Administration (FDA) has released a draft guidance document outlining its thinking on Unique Device Identification (UDI) labeling and data submission requirements for 'convenience kits' of two or more medical devices packaged together for user convenience, which are not to be modified before use.