The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting about Medical Device Recalls. During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication.
The Committee will consider concerns patients have about changes to their device in response to a recall and ways patient perspectives could be incorporated in the FDA’s and industry’s benefit-risk decision-making of recalled medical devices. The Committee will also consider the patient and healthcare provider decision-making process with respect to recalled devices, including implanted devices.
• Meeting Date: Wednesday, October 6, 2021, 10:00 a.m.- 5:00 p.m. EST
• Location: This public meeting will be webcast.
• Breakout Session Registration Deadline: Wednesday, September 22, 2021, 5:00 p.m. EST