I would like to know in what cases does the FDA needs to approve or certify a manufacturing facility in order to beging production....

Is there a reference to see the requirements and steps to have the FDA approve the facilities?

Cost, how long does it take, etc.

Thanks in advanced for the help.

I changed the Title to better reflect what I believe you are asking about. If this title isn't what you want, let any of the Moderators know and they will be happy to change it.

What are you manufacturing?

Hi Doug;

Currently we are manufacturing medical devices class I and II, but we are quoting a device class III that would requires a cleanroom class 7 (10000).

If it make any difference, you might need to know that we are a contract manufacturer.

Thanks.

Hi Doug;

Currently we are manufacturing medical devices class I and II, but we are quoting a device class III that would requires a cleanroom class 7 (10000).

If it make any difference, you might need to know that we are a contract manufacturer.

Thanks.

The first step is - you need to be FDA Registered (http://www.fda.gov/cdrh/reglistpage.html) - is your establishment registered ?

Yes, we are FDA Registered.