FDA Concept richtsnoer voor Unique Device Identification

On September 24, 2013, FDA published a final rule establishing a unique device identification system, including unique device identifier (UDI) labeling and data submission requirements.
This draft guidance document is intended to outline the agency’s proposed thinking that “convenience kit”, as defined by 21 CFR 801.3, applies solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. This position would constitute a change in policy (FDA website, 4 januari 2016).
Klik hier om het concept richtsnoer te downloaden (340 kB).
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