February 22, 2023

Real-Time or Accelerated Aging?

As a general rule in the medical device sector, accelerated aging data is expected to be ultimately backed up with real-time data.  Consequently, we still generally need to have real-time data to support whatever (let’s say, a 6-year) shelf life we are targeting.  If for example we have a 4-year real-time aging study but 6 years worth of accelerated aging, then we can label with a 6-year expiration date in the interim until 6 years of real-time data are completed.