Overview of the US FDA GMPs: Good Manufacturing Practice (GMP)/Quality System (QS) Regulation (21 CFR Part 820)

摘要

The FDA current good manufacturing practices/QS regulation/21 CFR 820 are designed to ensure the ultimate recipient of the device, the end user/patient/ clinician, is provided a device that is safe and effective. Furthermore, with the risks known, the benefits of use should outweigh its risks, and include on-going efforts to further reduce such use risks over the life of the product.