FDA Manufacturing Site Requirements

LievenDW

Involved In Discussions
#1
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?
 
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MIREGMGR

#2
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?
No and no, except that production processes and facilities must be suitable to cause the manufactured devices to conform to specifications...which may be more complex and stringent for some higher-class devices.

See 21 CFR 820.70.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
No and no, except that production processes and facilities must be suitable to cause the manufactured devices to conform to specifications...which may be more complex and stringent for some higher-class devices.

See 21 CFR 820.70.
Hi,

I would add on to that, that the specific device code may have "special controls" in place, and these in turn may include specific requirements wrt the manufacturing environment.

Cheers,
Ronen.
 

bio_subbu

Super Moderator
#4
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.
 
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