Hi, I have a question about FDA's manufacturing site requirements. Do they have specific requirements linked to the class of devices manufactured in a particular site? Are there special requirements for class III manufacturing facilities?
The FDA does not have specific manufacturing site requirements based on device classes. Site requirements depend on the manufacturer’s device specifications and processes. However they must meet the environmental controls requirements in the Production and Process Controls as per the section
21 CFR 820.70.
Although the FDA does not have device class linked manufacturing requirements, the site, equipment, monitoring, maintenance, etc. must be compatible with the intended use of the device. For example, an implantable device should be sterile and free from debris, so a manufacturer would be wise to make the device in a clean room and to have it sterilized, (at the manufacturer’s facility, by a contract sterilizer or by the user facility), before placement in a patient.