We are a relatively new company in the UK who make contact lenses which are classed as a medical devices. We will in time be looking to supply the US market so are looking towards FDA approval. What I need to know is we are currently trying to validate an R&R procedure for our measuring gauges and the method we have are currently looking at is used by Ford. I have come to understand that this procedure comes from Measurement System Analysis third edition.
Can anyone tell me if this standard would be sufficient and recognised by the FDA?

:thanx:

The requirement from 21cfr820.72 (http://a257.g.akamaitech.net/7/257/2422/01apr20051500/edocket.access.gpo.gov/cfr_2005/aprqtr/21cfr820.72.htm), states in partEach manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.I think it will be acceptable since they they leave it to you to determine the methods to use, but ISO 10012 is listed on the FDA list of Recognized Consensus Standards (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm). I would compare them just to be safe.