Question

Define what is meant by “substantial equivalence”. What is one significant limitation of the 510(k) pathway?

Answer 1

The concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time.Same goes with the new device which comes in the market.

Basically substantial equivalence is checking reliability of any new product, device or food by comparing it with the existing one

Limitations

Device creep :Where you are comparing 2018 device with 1976 pre amendment devide so obviously vast difference occur in those product in period of time.

Split Predicates: In this companies will rely on device A to establish substantial equivalence to products intended use, device B for its technological characteristics and Device C from material from which it is made. But in this case there is no single product to which new product is substantially equivalent to.

Quite a few 510K products have not required clinical data but perhaps now it might have addressed better with clinical data.