Home Brew Product

A product that a lab develops ‘in-house’ from existing products, reagents and components already on the market for use within the lab or hospital, and not intended for commercial manufacture, sale, or distribution
Mentioned in ?
References in periodicals archive ?
What has perplexed and angered the lab community is that the FDA has lumped home brew products in with all the other products to be regulated.
Some rushed to assert that the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), not the device premarket approval process, is the appropriate legal authority over home brew products.
The Washington law firm of Schwabe, Williamson & Wyatt suggests that a main problem posed by the FDA is one of semantics, since it seems to define labs that create home brew products as commercial manufacturers.

Full browser ?