1. Scope

Keywords

Rationale

Coating of stents is common and the long-term durability of these coatings needs to be evaluated. USP 788 is not appropriate for this evaluation, nor is there another standard that is applicable. It will be used to provide guidance on how to fulfill regulatory testing requirements aimed at the safety and efficacy of these products for the benefit of patients. The users will be manufacturers of coated stents, test labs and regulatory agencies.