Medical Device "Immediate Container" Interpretation of Definition

G

Gaby

Does the injection molded housing of an over-the-counter device in retail package form constitute the "immediate container" and thereby all markings required to go on the "label" of a device (name and place of business of the manufacturer, packer, or distributor, UDI) must be displayed "upon" it (directly applied to it)?

Some may be of the interpretation that, in a sense, the injection molded housing is a "container" of the working components of the device.

Our inclination is towards the interpretation that for an over-the-counter device in retail package form it is the retail package what constitutes its "immediate container" and what requires to bear all markings required to go on a device's "label"... any marks upon its injection molded housing would rather be "labeling" (e.g. "other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers").

Thanks in advance for sharing your thoughts.
 
somashekar

somashekar

Leader
Admin
If the injection molded housing is opened and the working components of the device taken out for use OR assembly and use (the device) while the injection molded housing is either kept aside for repacking or is discarded..... then the injection molded housing is the immediate container.
 
G

Gaby

Thank you Somashekar. No that wouldn't be the case. By "injection molded housing" I mean the housing encasing circuits, PCB, cables, etc., not intended to be opened or disassembled in any way by users.
 
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