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What are the regualtory and quality requirements for a company to buy off the shelf products such as standard AA batteries, power cables, cables adaptors for USB, etc. from the open market and stocking/selling them for use with their cleared medical devices under each of the following scenariors:
1) Company buys off the shelf product and uses the product Catalogue number in its own inventory tracking system. In this case, the product is not changed in any way.
2) Company buys off the shelf product and create its own Catalogue number in the form of a sticker or equivalent (overlabeling).
3) Company buys off the shelf product and creates another container with the appropriate labeling.
Assumption: all accessories have undergone the required test validation by the OEM and the buyer only performs the verification to demonstrate the accessories are compatible with their medical device.
All above scenario are for FDA.
By the way, is it OK for a company to buy off the shelf product and list itself on the labeling as the distributor?
thanks
1) Company buys off the shelf product and uses the product Catalogue number in its own inventory tracking system. In this case, the product is not changed in any way.
2) Company buys off the shelf product and create its own Catalogue number in the form of a sticker or equivalent (overlabeling).
3) Company buys off the shelf product and creates another container with the appropriate labeling.
Assumption: all accessories have undergone the required test validation by the OEM and the buyer only performs the verification to demonstrate the accessories are compatible with their medical device.
All above scenario are for FDA.
By the way, is it OK for a company to buy off the shelf product and list itself on the labeling as the distributor?
thanks