The “substantially equivalent” approval loophole is a textbook example of regulatory capture:
- approvals for version N + 1 are basically skipped, as is safety testing
- manufacturers get a liability shield
- for many classes of devices, ladder pulling implies that no one will ever get another v1 approved. (The current rules for that are impossible to meet, but the incumbent company is grandfathered in under the old rules).
- approvals for version N + 1 are basically skipped, as is safety testing
- manufacturers get a liability shield
- for many classes of devices, ladder pulling implies that no one will ever get another v1 approved. (The current rules for that are impossible to meet, but the incumbent company is grandfathered in under the old rules).