We produce a class 2 medical device that we have been under ICH guidelines for our stability and shelf life determinations. Our product contains an aerosol with no drug or active ingredient. We have looked into sterile medical device stability guidelines (ANSI/ISO 11607) to extend our expiry date from 2 to 3 years. We have the real time data to do that. My question is, is there another protocol like 11607 that addresses non-sterile medical devices?