The Key To Streamlining Regulatory Approval For IVDs

By Matthew Nowland

Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to success. Fortunately, many of those barriers can easily be avoided. In more than 30 years managing regulatory and compliance for medical device/IVD, & pharmaceutical companies — and interfacing with agencies in 167 countries — we have seen one approach work again and again:

Think about the end at the beginning.