Biological Evaluation of Legacy Medical Devices
Planning to market a legacy medical device in the United States? Your company will need a clear, well-documented Biological Evaluation that meets both ISO 10993 standards and the FDA’s guidance for use of ISO 10993-1.
We assist manufacturers in developing Biological Evaluation Plans (BEPs) and Reports (BERs).
Our approach is tailored for devices with a proven history of use, integrating risk-based analysis, historical data, and strategic testing recommendations to support a comprehensive and well-founded biological safety profile.
How We Support Your Biological Evaluation Process
We focus on legacy medical devices that already have a clinical background, but may lack complete material characterization or documented biocompatibility. How we can help you:
Development of the Biological Evaluation Plan (BEP): We define the overall strategy for biological safety assessment, including device identification, categorization, and the documents and phases required for evaluation.
Compilation of Existing Data: Our team gathers and interprets results from prior technical files—including material characterization, Toxicological Risk Assessments, and post-market data—to identify strengths and gaps.
Gap Analysis and Test Strategy: When required, we suggest additional testing or provide scientific justification for omitting tests, always based on the ISO 10993 biological evaluation of medical devices series and FDA recommendations.
Biological Evaluation Report (BER): We consolidate all data, perform a risk assessment, and deliver a detailed report that supports your FDA submission and aligns with global safety standards.
Strategic Regulatory Support: You receive expert input on how to align your biological evaluation with FDA expectations—whether you’re preparing for a 510(k), PMA, or De Novo submission.
All of our support is flexible and customized—final decisions remain with the manufacturer, allowing your team to maintain full control while benefiting from our technical insight.
Why do you need this service?
FDA expects manufacturers to apply the ISO 10993 framework to justify biological safety. Our evaluations align with both international standards and U.S. regulatory expectations.
Legacy products may lack complete material characterization or updated toxicological profiles. Our strategy helps fill those gaps using existing data, new test recommendations, or strong scientific rationales—avoiding unnecessary repetition or delays.
Our evaluations follow a risk-based methodology, focusing on real patient exposure and identifying biological endpoints that truly matter. This results in a more focused, efficient submission.
Whether you’re submitting a 510(k) or PMA, a clear Biological Evaluation Report enhances the credibility of your technical file—building confidence with FDA reviewers and reducing follow-up questions.
Need Support with Biological Evaluation?
With our deep understanding of ISO 10993 biological evaluation of medical devices and FDA regulatory expectations, we help you turn historical data into strategic documentation—to understand if your legacy devices are supported by science, structured planning, and solid justification.
Let Sobel help you develop a smart, compliant strategy for legacy device approval in the U.S. market.
