 Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems by the FDA

Primary FDA engineering guidance, April 18, 2010: www.fda.gov/media/71639/download . Section I defines deployment mechanisms; IV.B.4–11 covers recoil, radial response, integrity and durability. The official page notes a 2015 augmentation: www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-engineering-tests-and-recommended-labeling-intravascular-stents-and-associated-delivery .