Senators Want Answers From FDA Soon On Device Servicing Versus Remanufacturing
Executive Summary
US Senators Elizabeth Warren and Bill Cassidy recently sent a letter to FDA acting commissioner Ned Sharpless prodding him to provide them details by 1 November on how the agency plans to regulate medical device servicers that may actually be remanufacturing devices.
You may also be interested in...
Advanced Imaging Companies Lobby Lawmakers On Device Servicing, Reimbursement Among Other Issues
Advanced imaging companies spent hundreds of thousands of dollars in Q1 2020 lobbying Congress on issues as diverse as the national COVID-19 response and cybersecurity issues but are most interested in resolving device servicing and remanufacturing problems.
New MITA Standard Helps Servicers Of Imaging Devices Develop Quality Systems, Avoid Remanufacturing
The Medical Imaging & Technology Alliance has released a voluntary standard that guides servicers of medical imaging equipment on how to best set up a quality system. NEMA/MITA 2 also aims to keep servicers from crossing the line into remanufacturing – an FDA-regulated activity.
Trade Group Suggests New Guidelines On Imaging Device Servicing, Remanufacturing
A new white paper from the Medical Imaging & Technology Alliance suggests ways US FDA could better distinguish between imaging device servicing and remanufacturing. The agency has previously announced plans to clarify the difference.