by
Gus Iversen, Editor in Chief | November 29, 2017
From the November 2017 issue of HealthCare Business News magazine
FDA required to issue report assessing independent service organizations
The drama surrounding third-party service saw some significant progress toward resolution in 2017. It’s possible that we will be even closer to a conclusion between the time of this publication and when the year actually comes to an end.
It all started in early 2016 when the FDA opened a docket aimed at defining certain terms associated with non-OEM service pertaining to medical equipment. Roughly 176 organizations chimed in (some citing the lack of oversight third parties have through regulations, others pointing out the private interests OEMs have in eliminating competition).
What followed was a two-day workshop at the FDA headquarters in Silver Spring, Md., where stakeholders representing OEMs and third parties engaged in lively debate.
With the Medical Device User Fee Act signed into law by President Donald Trump in August, the FDA was given 270 days to issue a report on the service of medical devices as it pertains to patient safety.
The report, which will be posted to the FDA website, will also evaluate comments received from the initial docket and the workshop.
There is some speculation that the FDA may issue the report in advance of the congressionally imposed deadline. Since the completion of the two-day workshop, the FDA, principally through a 10-person internal FDA workgroup, has been hard at work carefully evaluating the comments and testimony received, while also listening to many different stakeholders.
The outcome of the investigation could cause major repercussions in health care and how hospitals think about equipment purchases and service contracts.
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