I think your referring to US FDA "Good Manufacturing Practices for Medical 
Devices". The actual description of the regulations is contained in 21 CFR 
Part 820. You can view the current GMPs at URL:

 www.medmarket.com/library/fda/part820.html.

There are new proposed rules by FDA that are still in the review process. 
This new rule is more in line with ISO methods and the EC Medical Device 
Directive (European). The proposed new rule can be viewed at URL:

http://www.medmarket.com/library/fda/new820.html

My last employer was a medical device mfgr. Normally component suppliers 
(i.e. PCB fab houses) don't have to worry about this. However, when you get 
involved with the assembly, and more importantly, the testing involved for 
declaring the device being "fit for use" then you do get involved in GMP.

Don Foster
Symbios Logic
[log in to unmask]

***************************************************************************
* TechNet mail list is provided as a service by IPC using SmartList v3.05 *
***************************************************************************
* To unsubscribe from this list at any time, send a message to:           *
* [log in to unmask] with <subject: unsubscribe> and no text.        *
***************************************************************************