Medical Device Event Compliance Checklist (2026)

Why Compliance Makes or Breaks Device Events

Medical device companies run thousands of physician-facing events every year. Lunch and learns, demo days, speaker programs, KOL dinners, advisory boards. Every one of these events involves transfers of value to healthcare professionals, and every transfer of value creates a reporting obligation under federal and state law.

The consequences of getting this wrong aren't theoretical. In 2023, CMS reported that device and pharmaceutical companies transferred over $12.6 billion in payments to physicians and teaching hospitals, all documented in the Open Payments database. Underreporting, late reporting, or failing to track transfers of value can result in civil monetary penalties up to $150,000 per violation.

This checklist covers the three phases of event compliance: pre-event planning, during-event documentation, and post-event reporting. Print it, share it with your event team, and use it as the starting point for your internal compliance review.

A note upfront: this checklist covers federal requirements (AdvaMed Code of Ethics, Sunshine Act/Open Payments, OIG guidance) and common state-level requirements. Your company's compliance team should review this against your specific policies, and you should always check state-specific rules for the state where your event is held.

Phase 1: Pre-Event Compliance Checklist

Event Purpose and Documentation

• Define and document the educational or informational purpose of the event. Every physician-facing event should have a written business purpose statement. "Educate dermatologists on [Device X]'s clinical applications for [Indication Y] supported by [Study Z] outcomes data" is specific and defensible. "Dinner with doctors to build relationships" is not.
• Prepare a formal event agenda. Include start time, end time, presentation topics, speaker name and credentials, Q&A period, and meal timing. The agenda should demonstrate that the meal is incidental to the educational content, not the primary purpose of the gathering.
• Get compliance department sign-off on the event plan. Most device companies require advance approval from compliance or legal before any physician-facing event. Submit the event purpose, agenda, venue, expected meal cost per person, and attendee list for review. Do this 30-60 days before the event.
• Verify the event is in a venue and setting conducive to education. The AdvaMed Code of Ethics requires that events occur in clinical, educational, or professional settings. Entertainment and recreational venues (golf courses, sporting events, ski resorts) are prohibited for company-sponsored educational events.

Meal and Hospitality Limits

• Confirm per-person meal budget against AdvaMed "modest" standard. AdvaMed doesn't set a dollar amount but requires meals be "modest as judged by local standards." Your compliance team likely has an internal cap, typically $75-150 depending on the city and meal type.
• Check state-specific meal gift limits. Several states have their own physician gift and meal limits that are stricter than federal thresholds. Vermont bans manufacturer-provided meals entirely for certain interactions. Minnesota requires reporting gifts over $50. Massachusetts caps industry-funded meals at $100. Check the specific state where your event takes place.
• Calculate total per-person cost including tax, gratuity, and alcohol. Your per-person figure must include everything, not just the food cost. A $75 entree becomes $110 after tax (8-10%), gratuity (20%), and a glass of wine ($15-20). If your cap is $125, that $75 menu price is tight.
• Confirm venue does not include entertainment or recreational components. No golf, no concert tickets, no spa packages bundled with the event. Even if the educational component is legitimate, bundling entertainment creates a compliance violation under AdvaMed and raises OIG anti-kickback concerns.

Speaker and Presenter Compliance

• Execute a written speaker agreement before the event. The agreement should document the speaker's qualifications, the scope of the presentation, compensation amount, and a statement that the speaker was selected based on clinical expertise (not prescribing volume or purchasing history).
• Verify speaker compensation reflects fair market value (FMV). FMV assessments should be documented and based on the speaker's specialty, geographic market, and the nature of the engagement. Overpaying speakers relative to FMV is an anti-kickback risk. The OIG's compliance guidance for pharmaceutical manufacturers (which device companies also reference) specifically calls out speaker compensation as a high-risk area.
• Confirm slide deck has been reviewed by medical/legal/regulatory (MLR). Every presentation used at a company-sponsored event should be reviewed and approved by your MLR team. Off-label promotion in a sponsored event creates both regulatory risk and speaker liability.
• Ensure speaker discloses financial relationships at the start of the presentation. The speaker should verbally disclose their consulting or speaking arrangement with your company at the beginning of the presentation. This is standard practice and aligns with ACCME requirements for CME-eligible activities.

Attendee List and Invitations

• Invite only HCPs with a legitimate professional interest in the topic. Inviting a dermatologist to an orthopedic device presentation raises questions about why they're there. Keep invitations targeted to the specialties your device serves.
• Do not invite spouses, guests, or plus-ones. Under AdvaMed, hospitality should not be extended to guests or companions of HCPs. Family members dining on the company's tab is a clear violation.
• Maintain a documented invite list with NPI numbers. You'll need NPI numbers for Sunshine Act reporting. Collect them during registration, not after the event when it's harder to track down.
• Exclude sanctioned or debarred individuals. Cross-reference your invite list against the OIG exclusion database (LEIE) and the GSA System for Award Management (SAM) exclusion list. Providing meals or payments to excluded individuals creates significant legal risk.

Phase 2: During-Event Compliance Checklist

Attendee Sign-In and Documentation

• Set up a formal sign-in process at the registration desk. Every attendee must sign in with their full name, professional credentials (MD, DO, NP, PA), NPI number, and practice name. This sign-in sheet is your primary compliance record.
• Use a printed sign-in sheet or digital check-in system. Paper sign-in sheets work but are harder to reconcile after the event. Digital check-in (QR code scanning, tablet sign-in) captures data more accurately and integrates with your CRM for follow-up. Either way, the data must be captured at the door, not reconstructed later.
• Record actual attendance, not just registration. Registered but absent physicians should not be reported as receiving a meal. Track who was actually in the room when food was served. This distinction matters for Sunshine Act reporting accuracy.
• Capture meal value per attendee. If the meal is a plated dinner, the per-person cost is straightforward. For buffets, divide total food and beverage cost (including tax and gratuity) by the number of attendees present. Document this calculation.

Content and Presentation Compliance

• Ensure only MLR-approved materials are presented or distributed. No improvised slides, no off-label claims from the podium, no unapproved handouts. If the speaker deviates from approved content, your company representative should address it during the Q&A or afterward.
• Record the actual presentation start and end time. This documents that the educational component was substantive and not a pretext for a meal. A 10-minute presentation followed by a 90-minute dinner looks problematic. A 45-minute presentation with 15 minutes of Q&A followed by a 60-minute dinner looks proportionate.
• Do not distribute promotional items with a value exceeding $10. AdvaMed prohibits non-educational promotional items (branded pens, stress balls, etc.) and limits educational items to $10 in value. Clinical reference cards, dosing guides, and approved patient education materials are acceptable. Branded merchandise is not.

Photography and Consent

• If photographing or recording the event, obtain consent from attendees. A sign at the registration desk stating "this event may be photographed for internal/marketing purposes" is a minimum. For recordings that include identifiable individuals, get written consent.
• If any demonstrations involve patients or human subjects, execute separate clinical consent forms. This is covered in detail in our medical device demo day planning guide.

Phase 3: Post-Event Compliance Checklist

Sunshine Act / CMS Open Payments Reporting

• Calculate the reportable transfer of value for each attendee. This includes the meal value, any educational materials provided, and travel reimbursement if applicable. The current reporting threshold is $12.49 per interaction (2025 figure, adjusted annually by CMS). Any individual transfer of value at or above this threshold must be reported.
• Report physician payments to your company's Open Payments data collection system. Most device companies have an internal system for aggregating reportable payments throughout the year. Submit your event data within 30 days of the event so it's captured in the next reporting cycle.
• Categorize the payment correctly. CMS Open Payments has specific categories: "Food and Beverage," "Compensation for Services Other Than Consulting" (speaker fees), "Travel and Lodging," etc. Miscategorizing payments can trigger CMS review.
• Reconcile attendee list against sign-in sheet. Only report meals for physicians who actually attended and were present when food was served. Reporting a meal for a physician who registered but didn't show up is both inaccurate and a waste of your reporting capacity. Cross-reference your registration list against the sign-in sheet and only report confirmed attendees.

Speaker Payment Reporting

• Report speaker honoraria and travel reimbursements separately from meal values. The speaker's meal is reported as food and beverage. Their honorarium is reported as compensation for services. Their travel is reported as travel and lodging. Each category appears separately in the Open Payments database.
• Confirm payment was made per the speaker agreement terms. Document when payment was issued and that it matches the agreed-upon FMV rate. Discrepancies between the agreement and actual payment create audit risk.

Record Retention

• Retain all event documentation for a minimum of 7 years. This includes the event purpose statement, agenda, attendee sign-in sheet, meal cost documentation, speaker agreement, FMV assessment, MLR-approved slide deck, and any consent forms. The statute of limitations for False Claims Act violations is 6 years (10 years if the government intervened), so 7 years is the conservative retention period.
• Store records in a centralized, accessible system. If a compliance audit requires you to produce documentation for an event you ran three years ago, you shouldn't be digging through a rep's email to find the sign-in sheet. Use your company's document management system.

State-Specific Meal Limits: Key States to Watch

Federal reporting requirements apply everywhere, but several states have additional restrictions that can catch out-of-state event teams off guard.

• Vermont: Annual disclosure required for payments over $25 to HCPs. The Vermont Attorney General publishes manufacturer payment data separately from CMS Open Payments.
• Minnesota: Gifts valued over $50 per year (aggregate) to individual practitioners are prohibited. Meals are included in the gift calculation. A $75 dinner and a $30 lunch in the same year to the same physician exceeds the threshold.
• Massachusetts: Meals must not exceed $100 per physician per event. Annual aggregate gift cap of $100 per physician from any single company.
• District of Columbia: Aggregate gift limit of $100 per year per HCP. Reporting required for gifts over $25.
• Connecticut: Annual reporting of payments over $78 per HCP. Compliance program certification required.

Always check the specific state's pharmaceutical marketing regulations before hosting an event. State laws change, and new states periodically enact gift and meal restrictions.

Common Compliance Mistakes

Based on events we've supported and conversations with compliance teams, these are the mistakes that come up repeatedly:

• Reconstructing the attendee list after the event. If you didn't have a sign-in sheet, you end up estimating who was there based on rep memory and email RSVPs. This produces inaccurate Sunshine Act reports. Always capture attendance at the door.
• Forgetting to include tax and gratuity in per-person meal cost. The compliance cap is on total cost, not the menu price. A $100 per-person menu becomes $130 after tax and tip. If your cap is $125, you've exceeded it.
• Inviting spouses or office staff who aren't HCPs. Meals for non-HCP guests are not reportable under Open Payments, but providing them raises questions about whether the hospitality is a gift to the physician (who benefits from their spouse's meal). Keep attendee lists limited to HCPs with a professional interest in the topic.
• Running events at entertainment venues. A dinner at a restaurant near a golf course is fine. A dinner at the golf course clubhouse after a round of golf is a clear AdvaMed violation. The venue matters.
• Late submission of event data to internal compliance systems. Waiting until Q4 to report Q1 events means you're reconstructing details from 9 months ago. Submit event compliance data within 30 days while the details are fresh.

For help with event registration infrastructure that captures NPI numbers, tracks attendance, and produces clean compliance records, explore our event marketing service. For the KOL dinner format specifically, see our KOL dinner planning guide. For the lunch and learn format, see our lunch and learn playbook. And for speaker program compliance, see our physician speaker program planning guide.