510(k) Submissions in 2025:

Key Challenges and Updates

Posted on September 2, 2025

Navigating FDA 510(k) submissions in 2025 remains critical for medical device companies. At IMDS Consulting, we’ve seen evolving challenges in biocompatibility, software, and cybersecurity. Here’s what you need to know.

Biocompatibility Challenges

The FDA emphasizes ISO 10993-1 compliance for biocompatibility. In 2025, expect stricter scrutiny on material safety data. Common issues include incomplete testing (e.g., missing cytotoxicity or sensitization data) and outdated risk assessments. To avoid delays, submit comprehensive biocompatibility reports via eSTAR, including chemical characterization and toxicological risk analysis. Pro tip: Engage early with testing labs to align with FDA expectations.

Software as a Medical Device (SaMD) Updates

Software devices face heightened requirements. The FDA’s 2025 guidance pushes for robust Software Bill of Materials (SBOM) and lifecycle management plans. Incomplete validation or unclear intended use can trigger Additional Information (AI) requests. Ensure your eSTAR submission details software architecture and risk mitigation per IEC 62304.

Cybersecurity Changes

Cybersecurity is non-negotiable. The FDA’s 2023 guidance (effective 2025) mandates threat modeling and vulnerability assessments. Submit a cybersecurity management plan, including post-market monitoring. Recent rejections highlight weak encryption or unaddressed vulnerabilities.Need Help?
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