On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of certain medical devices. In its announcement of the meeting, FDA stated it is concerned that lack of standardized content and format and access to medical device labeling may increase the risk of medical errors. Standardization and public access to medical device labeling raises several potential regulatory concerns (e.g., the ability to make modifications to the labeling) and could have product liability implications. Therefore, we recommend that clients closely follow FDA’s proposals and developments onthis issue and consider submitting comments.
The meeting will be held at FDA’s White Oak campus in Silver Spring, MD and will also be webcast. All attendees are required to register by April 5, 2013. Registration can be accessed through FDA’s Medical Devices News & Events - Workshops & Conferences calendar available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshipsConferences/def ault.htm. Early registration is recommended due to the limited space and webcast connections. On-site registration will be offered the day of the meeting if time and space allow. As part of the registration process, interested persons may request to make oral presentations during the public comment period of the meeting. Requests for oral presentations must be received by April 5, 2013, 5:00 pm EST.
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