Regulation 21 CFR Part 820.30(i) outlines FDA's requirements for design changes, but is unclear about planning and inputs. These elements need to be addressed and documented during any device design changes and efforts. We provide a list of steps to follow.
Advice from an IP expert before you take a meeting with a third party. The goal is to ensure that an inventor's invention will remain a valuable asset to him or her, and that the secrets surrounding the invention are kept safe.