May 24, 2018
EMERGO SUMMARY OF KEY POINTS:
The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services.
In a recent report, FDA addresses the quality, safety, and effectiveness of servicing medical devices.
As the report was a required provision of the 2017 Food and Drug Administration Reauthorization Act (FDARA), the contents of the report stem from a 2016 open docket and public workshop. The aim is to shed light on the quality, safety, and effectiveness of device servicing by original equipment manufacturers (OEMs) and third party servicers to determine if additional regulations are required.
With differing views on the quality of device service provided by OEMs, independent service organizations, healthcare establishments, biomedical and clinical engineers, healthcare technology management professionals, and professional trade associations, the report reveals objective information. Some conclusions include:
While imposing additional/different regulatory requirements is deemed unnecessary due to insufficient evidence, the FDA does intend on acting regarding medical device servicing. A few examples are:
The FDA’s Center for Devices and Radiological Health (CDHR) has established a forum, or Collaborative Community, where information is exchanged between the public and private sectors to solve shared problems. With the success of the FDARA report’s public exchange and the success for the CDHR Collaborative Community, the FDA is now considering establishing such a Collaborative Community targeting quality, safety and effectiveness of OEMs and device servicing.
EMERGO will provide any updates to the FDARA report on medical device servicing as well as and information regarding the creation of any collaborative communities as they are announced.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: