Regulatory

FDA to Test out New Standardized Medical Device Labels in Proposed Study

By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development.

Background

At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to strict requirements regarding everything from the font size and required information to layout and required statements.

But among FDA officials, there is a growing recognition that a lack of standardization is potentially harming patients. There is a “growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible,” FDA wrote in a 4 January 2013 Federal Registerannouncement regarding device labeling.

In addition, “There is no single available source of medical device labeling for people to view, search and download for devices that are used in clinical and non-clinical environments,” FDA wrote. Unlike pharmaceutical products, which typically have a shorter shelf life, the longevity of medical devices may mean that their instructions for use and warning labels are damaged or illegible after a few years. If these labels are unavailable, patients may be harmed as a result.

– See more at: http://www.raps.org/Regulatory-Focus/News/2014/09/15/20315/FDA-to-Test-out-New-Standardized-Medical-Device-Labels-in-Proposed-Study/#sthash.YTAaY882.UvYYiZda.dpuf

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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