Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

September 18, 2023By Philip Won & Véronique Li, Senior Medical Device Regulation Expert

Over the last three and a half years, meetings with FDA were conducted virtually.  During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform.  Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again engage in in-person meetings with the Agency.  CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation.  Drawing from our recent experiences, we outline practical tips to enhance your experience when engaging in these crucial interactions with CDRH.

Before the Meeting: Preparing for Your FDA Campus Visit

Most FDA meetings at CDRH are related to product submissions.  For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance).  To initiate this process, follow the Q-submission Guidance, which recommends indicating your interest in an in-person meeting.

Upon receiving your pre-submission, CDRH will assign a lead reviewer who will work with you to schedule the meeting date and time.  Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.  In turn, the FDA lead reviewer will email you with a list of FDA’s expected in-person and remote attendees, visitor information, visitor parking and campus map, and security instructions.  If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting.  Having a hard copy of this email may expedite your entry through security checkpoints.  We also suggest confirming that you will meet in Building 66, the office building occupied by CDRH.

Getting to Building 66

Most CDRH meetings occur in Building 66.  If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting.  Be prepared to show a copy of the email from the FDA lead reviewer, which may be required for access, although that is not always the case.  After ID verification, you will be directed to park in the visitor lot and may be told to take a shuttle to Building 66.

If someone else is dropping you off, arrange to be dropped off at the Building 1 Circle and take a shuttle from there.  We recommend leaving ample time as the shuttle makes multiple stops.  Some FDA lead reviewers may indicate a specific time that you need to arrive at Building 66 to ensure everything is set up properly on time.

Inside Building 66

Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in.  Green card holders will be asked to show their permanent resident card.  Non-U.S. citizens, including green card holders, must follow additional steps, so consult with your lead reviewer for guidance.

Expect security screening procedures, including metal detectors and bag x-rays, similar to airport security.  Security will also request contact information for the FDA staff escorting you to the meeting room.  The contact person is typically the lead reviewer.  Having a hard copy of your email correspondence can facilitate this process.  In the past, FDA sent a separate email with a bar-coded form for entry purposes.  Our recent experiences indicate that is no longer the practice.  Additionally, recent visitors did not have to scan their identification cards through an electronic machine.

To account for potential delays during security checks, we suggest that you arrive at the FDA campus well in advance of your meeting.  This allows time for parking, shuttle transportation, security checks, and room setup.

In the Meeting Room

During hybrid FDA meetings, sponsors often use their laptops to present slides.  If there will be virtual attendees, we recommend coordinating the Zoom setup with the FDA lead reviewer in advance to ensure that remote participants will be able to see the slides.  Double check and circulate the Zoom link to virtual attendees before the meeting to avoid potential delays.

As a sponsor projecting slides, you will need access to the FDA visitor’s Wi-Fi so that remote participants can view the presentation.  An FDA IT professional will likely be on-site to provide you with the unique log-in and password to connect and assist with connecting your laptop to FDA’s teleconference equipment, which includes a projector and microphone.  Be ready with backup options (e.g., a high-speed wideband hotspot) in case FDA visitor’s Wi-Fi access is unavailable for you.  You may also find it helpful to bring hard copy slides in case there are technical difficulties.  It is advisable to resolve all technical issues relating to the presentation of slides before the time of the meeting, if possible.  Otherwise, precious minutes can be spent while IT issues get worked out.

Our experiences with hybrid meetings were excellent.  CDRH IT staff was available to assist with the audio and video equipment and Zoom setup in the meeting room.  The audio and video equipment helped with a seamless meeting experience.  The video equipment dynamically followed the speakers and presented them on the screen.   Our experience with CDRH paralleled Frank Sasinowski’s observations in his interview with the Pink Sheet earlier this year.  After his participation in the first hybrid meeting at CDER on March 28, 2023, Sasinowski remarked that the interaction between the FDA and sponsors felt more close-knit, resulting in a more intimate meeting atmosphere.

Leaving the Meeting Room

In-person and hybrid FDA meetings provide invaluable opportunities for industry professionals to engage with FDA staff.  In particular, we have found that speaking informally with the FDA review team before and after the meeting personalizes and humanizes the experience and facilitates a greater understanding of the topics at hand.

Remember that even the best-planned meeting can face unexpected incidents, so being well-prepared improves the odds of a smooth and productive experience.


Categories: Medical Devices