AAMI News September 2017, Volume 52, Issue 9
The FDA Reauthorization Act of 2017 is poised to impact the healthcare technology community in two significant ways: renewal of the “user fees” imposed on medical device manufacturers and with a call for a report on the issue of medical device service, especially by third parties.
Risk management is more than just checking boxes or filling out forms to satisfy regulatory requirements; it is an essential part of the design process, according to a new guide on the subject for startups and other manufacturers new to the healthcare arena.
The Food and Drug Administration (FDA) says it is moving ahead with plans to reduce regulatory burdens and promote medical device innovation as required by the 21st Century Cures Act, including changes to the way it recognizes voluntary consensus standards for medical devices.
The healthcare industry needs a better understanding of the troubling issue of fires and explosions in high-capacity batteries used in hospital carts and should turn to standards and education to address the problem, according to a diverse group of experts.
- News in Brief
- Personal Experiences Inspire Students' Winning Essays
- FDA Finalizes Guidance on Medical Device Development Tools
- Clinicians Monitor the Present to Predict the Future
- Patient Danger Prompts Life-Saving Expansion of Capnography
- 'It's OK to Disagree' and Other Lessons from Developing Standards
- Tech World: HTM Department Works on 'Cure' for Global Device Challenge
- The Big Picture: FDA Leveraging/Collaboration Award
- Professor Reflects on Changes, Challenges in HTM Education
- Biomed Breaks the Mold by Working for Veterinary Practice
- One on One: Mike Ziemelis
- Volunteer Spotlight: Matt Dummert
- Members on the Move
- Spotlight on Standards: AAMI Standards Board Approves Seven Documents
- Advertisers in this Issue