Combination products, which integrate medical devices with drugs or biologics, are subject to stringent FDA regulations. Ensuring compliance post-market is essential for maintaining product safety and efficacy. The FDA requires that adverse events related to combination products be reported through the FDA Adverse Event Reporting System (FAERS) using the ICH E2B(R3) standard. Companies must submit Individual Case Safety Reports (ICSRs) electronically, with full compliance expected by April 1, 2026. Two primary submission methods are available: database-to-database transmission (E2B) or the Safety Reporting Portal (SRP).
In addition to ICSRs, companies are required to submit Periodic Safety Reports (PSRs), which include detailed summaries of adverse events and non-expedited ICSRs. These reports are submitted via the Electronic Common Technical Document (eCTD) format to ensure proper documentation and regulatory oversight.
Why This Matters: Post-market surveillance plays a critical role in the lifecycle management of combination products. These submissions allow the FDA to monitor safety issues and trends, mitigating risks that may arise once a product enters the market. As combination products blend elements of medical devices and pharmaceuticals, regulatory compliance ensures that any adverse reactions or device malfunctions are addressed quickly, safeguarding public health.
For organizations handling combination products, understanding and adhering to these submission requirements is vital to maintaining market access and avoiding regulatory penalties.
Key Takeaways:
Electronic submission of ICSRs via FAERS is required by April 2026.
The ICH E2B(R3) standard is used for database-to-database transmission or submission through the Safety Reporting Portal.
Periodic Safety Reports (PSRs) must be submitted through the eCTD format.
Effective post-market reporting safeguards patient safety and ensures regulatory compliance.
For more detailed guidance, visit the FDA’s page on FAERS electronic submissions. Contact OneGlobal Trinity M Consulting today for support with your post-market reporting requirements.
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