FDA to Host a Public Workshop on Standardised Medical Device Labelling
Published date : 22 January 2013
Article date : 22 January 2013
Insidemedicaldevices.com reports that the FDA will host a 2-day public workshop in April where the organisation aims to obtain feedback from stakeholders about standardising medical device labelling and creating a publicly available repository of device labelling.
They say that improving the accessibility and usefulness of medical device labeling is a strategic priority of the Center for Devices and Radiological Health (CDRH) this year. As part of the agency’s efforts, in May 2011, the FDA published the results of a focus group study with health care practitioners exploring provider satisfaction with current device labelling and potential changes. Focus group participants expressed the need to revise device labeling to make it concise and simple. Caregivers who use home use devices were also surveyed from October 2011 through January 2012 and expressed a desire for standardised labelling with access to a “quick guide” with instructions for use.
The FDA has already taken steps towards an online repository of medical device labelling for home use devices. They had expressed concern about the safe use of devices in the home and launched the Home Use Devices Initiative in 2012. it was through this initiative that the FDA stated that it will develop an online labeling repository for devices approved or cleared for home use.
If you are interested in attending or making a presentation at the workshop, you must register by April 5. The workshop will also be live webcast if you cannot attend in person. The FDA is accepting written comments until April 12, 2013.
Source: Afia Asamoah, Insidemmedicaldevices.com, 17 January 2013
