FDA Provides Guidance on the Regulation of Multiple Function Products with Some Functions that Fall Outside the Medical Device Umbrella
Author: Suzanne Broussard, PhD | January 5, 2021 The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions […]
FDA’s Updated Electronic Medical Device Reporting (eMDR) System Aims to Harmonize Adverse Event Reporting
Author: Suzanne Broussard, PhD | November 9, 2020 FDA’s recently finalized modifications to the electronic Medical Device Reporting (eMDR) system include the addition of new fields to harmonize with terminologies set by the International Medical Device Regulators Forum […]
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 […]