The U.S. Food and Drug Administration (FDA) will hold a public meeting on April 29-30 to discuss the need for standardized medical device labeling to be delivered in a clear, concise, and readily accessible format for patients, caregivers, and healthcare providers. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling. For background information, read “FDA Proposes Medical Device ID System.”
The meeting will be held at the FDA’s White Oak campus in Silver Spring, Maryland, and will also be webcast. All attendees and webcast viewers must register by close of business on April 5. Requests for oral presentations during the public comment period can be made at registration and must also be received by April 5 at 5 p.m. ET. 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.
Regardless of attendance, comments can be submitted electronically at www.regulations.gov or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852. Reference Docket Number FDA-2012- N-1205.
For detailed information about the meeting location, registration, comment submission, and agenda, read the Federal Register meeting notification, Docket Number FDA-2012-N-1205.
