The FDA’s Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in‑process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. FDA Warning Letters frequently cite this section of the regulations; it is in the top five sections cited.
This presentation explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We explain the advice offer FDA’s QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. The FDA has recommended, in Warning Letters, that manufacturer’s obtain a copy to help them come into full compliance.
The presentation concludes with an examination of some Warning Letters. We review some mistakes that manufacturers have made and point out ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.