Combo product QSR
This article was originally published in The Gray Sheet
Executive Summary
Combination product compliance with device quality system regulations and drug current good manufacturing practices "can generally be achieved" by following either set of regs when the components are produced together, since "under a more general requirement in one set of regulations, it will be possible to develop and implement a practice that complies with a more specific requirement in the other set," FDA explains in a 1Sept. 29 draft guidance. On Sept. 27, the agency released a new list of jurisdictional determinations: combo products under CDRH include coronary stents with biologicals, orthopedic prostheses with growth factors, dialysate with drug components, and vascular grafts with antibiotics. The designations are based on "primary mode of action" (2"The Gray Sheet" May 10, 2004, p. 12)...