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FDA Is Holding Virtual Panel Meetings for Medical Devices

August 11, 2020  •  Blog  •  Christy Foreman, MBE, Senior Consultant, Medical Devices
Posted In Medical Device News & Insights – Biologics Consulting  •  Tagged FDA, Medical Device – Biologics Consulting – Blog, Panel Meeting

Due to COVID-19, FDA/CDRH is beginning to hold virtual panel meetings for medical devices.  On Sept 8-9, 2020, the Orthopaedic and Rehabilitation Devices Panel will meet to discuss the classification of several pre-amendment devices including: facet screws systems, semi-constrained toe (metatarsophalangeal) joint prostheses, intra-compartmental pressure monitors and intra-abdominal pressure monitoring devices.   The panel will also consider the reclassification of non-invasive bone growth stimulators from Class III to Class II.  This panel will hopefully allow CDRH to “test-drive” the process before bringing a device seeking approval before the advisory committee.

These virtual panel meetings raise new challenges for companies who have invested significant time and funds into the development of a medical device.   The Cardiovascular and Renal Drugs Advisory Committee met on July 15, 2020.  That meeting suffered from many of the standard technological issues that have become common as COVID has forced the world to communicate through technology rather than in person.  That meeting had echoes when committee members spoke, speakers failing to take themselves off mute and pre-recorded presentations that failed to play among other issues.   Additionally, in a virtual panel meeting, does not have the ability to see and observe other panel members.  One isn’t able to know if their information is resonating with the committee.  One isn’t able to know if one is keeping the attention of the other panel members or if they have become distracted by the myriad of interruptions that plague our daily lives.  The virtual panel presents unique challenges where there is little precedent to rely upon for what makes for a successful meeting.  It will certainly take more preparation and planning to successfully prepare for a virtual panel meeting to maximize a company’s chances for a successful panel meeting.

Food and Drug Administration (FDA). (2020). Advisory Committees. Retrieved from source.

Food and Drug Administration (FDA). (2020). September 8-9, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. Retrieved from source.