Paper on QSR Definitions of component and manufacturing material

FDA’s QSR defines two terms that often confuse practitioners: component and manufacturing material. QSR defies these terms but confusion continues. This Ombu paper explains these terms and others as well. The broad term “product includes five things: component, manufacturing material, in=process device, finished device, and returned device. The paper discussed each of them and explains the differences and the requirements for each one.

You can read the paper Understanding Product in FDA’s QSR in the Medical Device Regulations section of the Ombu Library.