Manufacturers must establish and follow quality systems to help guarantee that their products consistently meet applicable requirements and specifications. The quality systems for fda, Regulated products food, Drugs, Biologics, And devices are commonly known as current good manufacturing practices cgmp s . Cgmp requirements for devices in part 820 Title 21, Chapter of the CFR 820 were first authorized by section 520 f of the federal food, Drug, And cosmetic act the act . Us govt. Give flexibility of qs regulation. This regulation does not prescribe in detail about how a manufacturer must produce a specific device rather, The regulation provides the framework that all manufacturer must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device in accordance with the current state, Of, The, Art manufacturing for that specific device.