FDA Patient Engagement Advisory Committee Meeting to Discuss Medical Device Recalls

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

2 thoughts on “FDA Patient Engagement Advisory Committee Meeting to Discuss Medical Device Recalls”

  1. I still have a Vitek-II which was recalled before it was placed in me in 1990. I read about in a magazine. My oral surgeon denied it. I was notified five years later by the FDA. I became ill six months which specials believe was caused by my implant. I have been ill with ME/CFS. No one will remove it and there is nothing to replace it. So since 1990 I have spent thousands of dollars going to a specialist in NC and dental work implant. It has ruined my life.

  2. Shirley, I am sorry for your struggle. Did you get the proplast fossa liner or their total joint replacement? Thank you. I have the liner installed in 1984.

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