Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types
Author: Suzanne Broussard, PhD | November 2, 2020 The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct […]
FDA Finalized Two Guidance Documents for the Abbreviated 510(k) Safety and Performance Based Pathway: Use of Performance Measurements Instead of Direct Comparison Testing for Medical Devices
Author: Suzanne Broussard, PhD | October 26, 2020 The Premarket Notification 510(k) Program is the pathway used by manufactures of low- to moderate-risk devices that are substantially equivalent to a device already on […]
