Best Practices for Early Orientation Meetings for Marketing Submissions for Medical Device Software

The FDA’s Center for Devices and Radiological Health (CDRH) has a longstanding history of leveraging the Interactive Review process to facilitate the efficient and timely review and evaluation of premarket submissions through increased informal interaction between the FDA review staff and applicants. As described in the FDA guidance “Types of Communication during the Review of Medical Device Submissions,” Interactive Review can improve the interaction between the FDA review staff and the sponsor during the review process, and it can prevent unnecessary delays in the completion of the review. As part of Interactive Review, it can be valuable when sponsors offer device demonstrations, provide an overview of the device submission, and answer early clarifying questions to help the FDA review team more fully understand the device under review and its intended use. We refer to this type of interaction as early orientation meetings, which can be particularly helpful for marketing submissions that include medical device software. The FDA recognizes that it can be difficult to fully convey the functionality of medical devices that include software in a traditional written marketing submission. These meetings are intended to be an optional, interactive review mechanism for sponsors to provide an overview and device demonstration to the FDA review team to facilitate understanding of a device under review. The following best practices for early orientation meetings are intended to support sponsors and review teams in this interactive exchange.

On this page  

• When to Consider a Meeting  
• Requesting a Meeting
• Scheduling the Meeting  
• Preparing for the Meeting
• Interacting with the FDA During the Meeting
• More Information

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When to Consider a Meeting

We recommend considering an early orientation meeting for marketing submissions with medical device software where a device demonstration would support and/or facilitate the FDA review team’s understanding of the device under review. For example, an early orientation meeting may be helpful for new or novel device software functions or devices that rely heavily on the software to achieve their intended use. On the other hand, for well-understood or established device types, an early orientation meeting may not be as valuable.

Early orientation meetings could include any of the following marketing submissions sent to the FDA:

• Traditional 510(k)s
• De Novo Requests
• PMAs (Original, Panel-Track Supplement, 180 Day Supplement)  

Requesting a Meeting  

Sponsors can request an early orientation meeting by including it in their cover letter and/or in an email to the lead FDA reviewer of the marketing submission. The FDA will try to accommodate meeting requests, resources permitting.  

The FDA may also reach out to a sponsor to request an early orientation meeting when the team thinks it would be helpful to have an overview and device demonstration during the review. However, there is no obligation for a sponsor to participate in an early orientation meeting.

Scheduling the Meeting  

Early orientation meetings are typically 30 to 60 minutes. It is generally most helpful to have the meeting during the first few weeks of a submission review. This early interaction helps the lead FDA reviewer and other team members, as appropriate, begin the review with a clear understanding of the subject device and its intended use.

The meetings are usually held remotely to facilitate timely scheduling for the FDA and sponsor. The FDA will accommodate in-person and hybrid meeting requests where feasible.

Preparing for the Meeting  

It is important for the FDA review team to understand the proposed context of use for a given device. Key items to provide context may include but are not limited to:

• Intended use of the device
• Intended user population (e.g., clinicians, patients, caregivers)
• Environment of device use
• General device workflow

Sponsors may wish to highlight how the medical device achieves its intended use. This could include explaining the following:

• Inputs:
  • Information taken in
  • Information delivery to the device (e.g., manually, via remote connection)
• Outputs:
  • Information the device provides
  • Intended target for the information
  • Algorithmic architecture of how the input(s) are converted to the output(s)

In the live and/or prepared product demonstration, it may be helpful to highlight:

• Typical workflow or use of the device
• New or novel features or functions of the device
• Any relevant onboarding or training information for users of the device
• Specific or notable risk mitigations designed into the device user interface

Sponsors may also wish to briefly describe the evidence provided in the submission to support the device under review.

Interacting With the FDA During the Meeting

Early orientation meetings are intended to be an interactive review mechanism. The meetings provide an opportunity for the FDA review team to hear an early overview of the device submission, see a device demonstration, and ask clarifying questions regarding the content presented to better understand the subject device and its intended use.

The FDA review team does not generally provide specific feedback on the submission during the meetings.    

More Information

For general questions about early orientation meetings, send an email to digitalhealth@fda.hhs.gov.  

For questions about a specific product or marketing submission, reach out to the most relevant Office of Health Technology (OHT) within the Office of Product Evaluation and Quality (OPEQ) at the FDA.