Modifications - Allowable or Not
Or… Will ODEP allow a manufacturer to keep a product’s present benchmark when they want to modify the device?
It has always been ODEP’s view that if:-
the implant is made of a new material
the working surface (the surface that is in contact with the patient’s skeleton) has been changed
the shape has been changed
It will be usually be regarded as a new device and will have to start the ODEP process from the beginning, the Pre-entry stage.
It has often been argued that there is no such thing as a “minor modification”. There have been instances of “minor modifications leading to major changes in performance, often for the worse.
Manufacturers are well advised to let ODEP know of any “modification” they wish to make to one of their devices and it is much better that ODEP is informed rather than ODEP finding out.
Some modifications are acceptable and acceptance is allowed on an implant by implant basis after exhaustive discussion. Often ODEP will seek advice from one or more of the bioengineers who they work with. ODEP also has access to toxicologists.