FDA makes 510(k) documentation easier for certain devices

Blog FDA Safety and Performance Pathway 510kPNG

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