Article preview from "The Gray Sheet"- July 30, 2012
FDA wants to know what information physicians, nurses and technicians would like to see in a shortened "quick guide" version of labeling as part of an effort that could result in more standardized device labeling.
Article preview from "The Gray Sheet"- July 30, 2012
FDA will begin surveying health care providers in August to assess whether adding a short summary section to typically complicated device labeling would make their life easier. The agency is also trying to assess the prospects of standardizing other features of device labeling.
Device labeling, distinct from drug labeling, does not currently follow any standard format, and the agency is curious to know whether practitioners would find a "quick guide" or "highlights" section helpful to understanding the indications, use and risks of a device, FDA says.
"FDA's thinking is that, similar to drug labeling, a standard content and format of the labeling could help the user to safely operate the device," agency spokeswoman Morgan Liscinsky told “The Gray Sheet.”
The survey
has been designed to help FDA formulate a policy to standardize medical device labeling, the agency said in first announcing the effort last November.
The Office of Management and Budget has now given FDA permission to poll approximately 624 health care providers in various fields. FDA says it will survey about 120 physicians, 240 advanced practice nurses and registered nurses, and 240 medical technicians. Twenty-four telephone interviews will also be conducted.
The survey is expected to take about 30 minutes to complete. It will be run for four to six months.
The effort follows on a series of nine focus groups FDA held last year with physicians, nurse practitioners and registered nurses which revealed that many health care providers “prefer to have some type of easy-to-read, easy-to-access and shortened version of labeling, instead of trying to find information in, at times, very lengthy labeling,” Liscinsky explained.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to "The Gray Sheet".
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments