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Polaris Biomedical sponsored this year's Rocky Mountain Regulatory Affairs Society (RMRAS) Annual FDA Update meeting, and I had the pleasure of spending the evening with some of Colorado's top manufacturers and regulatory professionals. Here is my breakdown of what went down, the big structural shifts at the agency, and what this all means for medical device teams on the ground. A Brand New Agency Map: The Shift to OII Mark Harris kicked off the presentations by walking us th

With QMSR alignment in February and issuing the Content of Human Factors Information in Medical Device Marketing Submissions guidance document in May, FDA has had a busy year. This guidance replaces the 2016 guidance that industry has been relying on for ten years. Let's go over what changed: The 2026 revision updates the regulatory framework around human factors to reflect the QMSR and ISO 13485:2016 rather than the old 21 CFR 820.30 design control structure. It also shifts

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.

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.

In March 2025, the FDA issued its finalized guidance titled "Evaluation of Sex-Specific Data in Medical Device Clinical Studies" ,...

In December 2024, the U.S. Food and Drug Administration (FDA) finalized its highly anticipated guidance on Marketing Submission...

Understanding FDA Draft Guidance and Industry Best Practices In the regulatory landscape, it is crucial to understand what a draft...

I hope this newsletter finds you well. We're dedicated to keeping you informed about significant regulatory updates that impact our...

The FDA's recent decision signifies a significant step toward harmonizing FDA requirements with ISO 13485