Combination products have been controversial topic since the introduction of 21 CFR part 4 in 2013. Combination products can consist of Drug & Device, Biologic & Device, or drug/Biologic. Most...

Good discussion so far everyone. As everyone have mentioned, Meeting minutes is considered to be a very important tool to track project progress and keep everyone on track. From my experience, if you ...

As we all have learned this week, a validation may not be required if: - There were no changes required to the product after verification. - A clinical trial is not required - Product changes did not ...

Let me start by defining what a legacy combination product is: Legacy Product: Products no longer under development but not retired from a company’s drug development program and are currently marketed...

Design inputs do not only include physical and performance characteristics of the device. Design inputs should also include functional requirements, safety requirements, applicable regulatory requirem...

This is a very common question in the medical device industry. The best way to look at it is to understand the definition of both Verification and Validation. From 21 CFR 820: - Design validation mea...