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RE: [IP] MM tubing response

Bonnie Richardson [mailto:email @ redacted] wrote:

> My response is #1 - What are the Regulatory Issues??

When medical products are approved for marketing and sale by the FDA, there
typically are restrictions on just *how* they may be sold.  It may be that
infusion sets are packaged according to the current FDA approval, and that
changing the packaging may require petition to and action by the FDA.  BTW,
FDA approval has nothing to do with they way the product is used . . . only
in how it may be distributed.

Jim Handsfield
mailto:email @ redacted OR
mailto:email @ redacted

The opinions expressed are my own and do not necessarily represent those of
my wife who runs this house and makes more important decisions than I do.
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