QMSR Section 820.1 (Scope)

The scope section of Part 820. The part covers the methods, facilities, and controls used to design, manufacture, package, label, store, install, and service finished devices for human use. Contract sterilizers, relabelers, repackers, remanufacturers, and initial distributors of foreign entities that perform those functions are included.

Where it is written

21 CFR 820.1(a)

Also called

21 CFR 820.1, 820.1

Related terms