FDA makes 510(k) documentation easier for certain devices
References
FDA, ”Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway”: https://www.fda.gov/media/130864/download
FDA, ”Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway”: https://www.fda.gov/media/130865/download
FDA, ”Safety and Performance Based Pathway”: https://www.fda.gov/media/112691/download