Understanding FDA Requirements for Medical Information Services in the US

In the highly regulated industry environment, medical information (MI) services are far more than a support function, providing information to patients, caregivers, and Healthcare Professionals; they’re a cornerstone of compliance. The Food and Drug Administration (FDA) sets clear expectations for how MI should be managed, communicated, and documented (FDA, 2023a).

Why FDA Requirements Matter

The FDA’s mission is simple: to promote and protect public health. When it comes to MI, this translates into adhering to a set of guidelines to ensure that every response is fair and balanced, scientifically sound, and evidence-based. Also, that information must meet promotional and non-promotional standards; non-negotiables include data integrity and ethical practices (FDA, 2023b). Non-adherence is more than a risk, it creates liability. Infractions to the guidelines can make a waterfall of warning letters, fines, and reputational damage (FDA, 2023c).

Key FDA Requirements You Need to Know

Adverse Event Reporting

Under 21 CFR Part 314.80 and 21 CFR Part 803, manufacturers and importers must report adverse events, serious injuries, deaths, and specific device malfunctions (21 CFR §314.80; 21 CFR §803). MI teams often serve as the first point of contact for these reports, making accurate intake and timely submission critical to compliance. Collecting details for adverse events is most successful during the first contact, highlighting the importance of training focused on identification, collection, documentation, and submission processes (FDA, 2023d).

Product Quality Complaint Reporting

As with adverse event reporting under 21 CFR Part 211.198, written procedures for handling all written and oral complaints regarding a drug product shall be established and followed (21 CFR §211.198). Again, MI teams often serve as the first point of contact for complaints. Identification, collection of pertinent information, documentation, and submission are critical to ensure the proper investigation of the complaint and enable manufacturers to take appropriate action (FDA, 2023e).

Best Practices for MI Teams

To ensure MI teams adhere to the guidelines for providing and capturing information pertaining to Adverse Events and Product Quality Complaints, continuous training of MI colleagues is key (FDA, 2023f). Well—developed and defined quality management plans to ensure expectations are clear to teams and teams and allow for appropriate oversight and feedback to teams. Equally important are robust, validated documentation systems that provide accurate record-keeping and support audits and inspections. Finally, maintaining consistent, compliant messaging across all channels to provide unbiased, scientifically supported communications to all requestors (FDA, 2023g).

The Bottom Line

These requirements act as safeguards to patient safety and product integrity. MI teams help build trust and protect public health by embedding compliance into every interaction (FDA, 2023h).

References

• FDA. (2023a). Guidance on medical information services and compliance expectations. U.S. Food and Drug Administration.
• FDA. (2023b). Promotional vs. non-promotional communications guidance. U.S. Food and Drug Administration.
• FDA. (2023c). Compliance and enforcement actions overview. U.S. Food and Drug Administration.
• FDA. (2023d). MedWatch and adverse event reporting requirements. U.S. Food and Drug Administration.
• FDA. (2023e). Complaint handling and quality system regulations. U.S. Food and Drug Administration.
• FDA. (2023f). Training recommendations for medical information teams. U.S. Food and Drug Administration.
• FDA. (2023g). Inspection readiness and documentation best practices. U.S. Food and Drug Administration.
• FDA. (2023h). Public health protection through compliance. U.S. Food and Drug Administration.
• 21 CFR §314.80 – Post-marketing reporting of adverse drug experiences.
• 21 CFR §803 – Medical device reporting.
• 21 CFR §211.198 – Complaint files.