Long ago and far away, clearance of a US device with FDA did not depend upon conformity to a standard. FDA, believe it or not, didn’t recognize “voluntary” standards and according to regulation, only FDA could issue a “performance” standard. Some years back, the ice broke and certain standards for evaluation of a device became “recognized”. One of the earliest was for the evaluation for biocompatibility (ISO 10993 Part 1), which took the place of the old “tripartite agreement”; and now we have a deluge of standards to consider for any new medical device. Soon the trickle became a roar and regulatory bodies began to see the wisdom of recognizing certain “peer reviewed” standards.