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FDA Finalizes Guidance on Computer Software Assurance: What Changed From the Draft
On September 24, 2025, the FDA released its long-awaited final guidance on Computer Software Assurance (CSA) for Production and Quality System Software, replacing the 2022 draft version.
Brittany Michael
Sep 264 min read
Regulatory Update: ISO 10993-1 Set for Major Revision
ISO 10993-1 is getting a major update, and it’s just weeks away. The new version has moved to “under publication” and is expected to be released within seven weeks. FDA recognition typically follows within months, with a 12–18-month transition period. Learn what this means for your biocompatibility strategy and how Polaris Biomedical can help you stay ahead.
Brittany Michael
Jul 211 min read
FDA Finalizes Guidance on Sex-Specific Data in Device Clinical Studies: What Changed from the January Draft?
In March 2025, the FDA issued its finalized guidance titled "Evaluation of Sex-Specific Data in Medical Device Clinical Studies" ,...
Brittany Michael
Apr 243 min read
FDA Finalizes Guidance to Streamline Updates for AI-Powered Medical Devices
In December 2024, the U.S. Food and Drug Administration (FDA) finalized its highly anticipated guidance on Marketing Submission...
Brittany Michael
Apr 103 min read
FDA Draft Guidance on Sex-Specific and Gender-Specific Data
Understanding FDA Draft Guidance and Industry Best Practices In the regulatory landscape, it is crucial to understand what a draft...
Brittany Michael
Jan 285 min read
New FDA Guidance on Cybersecurity in Medical Devices
I hope this newsletter finds you well. We're dedicated to keeping you informed about significant regulatory updates that impact our...
Brittany Michael
May 2, 20244 min read
FDA 13485 Harmonization
The FDA's recent decision signifies a significant step toward harmonizing FDA requirements with ISO 13485
Brittany Michael
Feb 2, 20243 min read
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