News

Wearable medical devices — continuous glucose monitors, cardiac monitoring patches, drug delivery wearables, diagnostic biosensors — are regulated medical devices. That means before they reach patients, they go through biological evaluation under ISO 10993-1:2025. For manufacturers new to the biocompatibility process, the question is usually: what does that actually require? The answer depends on your specific device — its materials, its patient contact, how long it stays on

The 510(k) pathway sounds straightforward on paper: demonstrate substantial equivalence to a predicate, submit your documentation, get cleared. In practice, the biocompatibility section alone can generate multiple deficiency rounds if it's not built correctly from the start. That's where a medical device consulting firm comes in. Not as a rubber stamp, and not as someone who fills out forms. A firm with deep regulatory and toxicological expertise shapes the strategy behind yo

ISO 10993-6:2026 was published in April 2026, replacing the third edition from 2016. If you're running implantation studies or reviewing biocompatibility data packages right now, this is the version that applies. The changes aren't cosmetic. Several of them close gaps that have caused inconsistent study design and confusing regulatory submissions for years. This article covers what changed and what it means practically for manufacturers, CROs, and regulatory affairs teams. Wh

Every implantation study under ISO 10993-6:2026 is built on a comparison. Your test sample goes in alongside a control, and the tissue responses to both are evaluated side by side. The conclusion — whether your device produces an acceptable local tissue response — depends entirely on what that comparison shows. That makes control selection one of the most consequential decisions in implant study design. Get it wrong and borderline histopathology results become very difficult

One of the most expensive questions in implantable device development is also one of the most frequently answered too quickly: Do we need an implantation study? The reflex answer — "it's an implant, so yes" — has led to a lot of unnecessary animal studies and a lot of unnecessary cost. The correct answer depends on your specific device, your materials, your existing data, and how you've structured your overall biological evaluation under ISO 10993-1:2025. ISO 10993-6:2026, th

Choosing the wrong implant test site is one of the more avoidable mistakes in biocompatibility study design and one of the more consequential ones. If your test doesn't reflect how the device actually contacts tissue in clinical use, your data may not support the conclusions you need, and FDA reviewers will notice. Under ISO 10993-6:2026, the test sample must be implanted into or onto the tissues most relevant to the intended clinical use of the material. The choice of tissue

Medical device risk management is the systematic application of management policies, procedures, and practices to identify, evaluate, control, and monitor risks throughout the device lifecycle. Under the QMSR and ISO 14971:2019, risk management isn't a one-time premarket activity—it's an ongoing process integrated with design controls, biocompatibility evaluation, and quality system operations. For manufacturers navigating regulatory requirements in 2026, effective risk manag

Biocompatibility testing for medical devices has fundamentally changed under ISO 10993-1:2025. The familiar endpoint matrix that automatically prescribed which tests to conduct based on device contact type and duration no longer exists. Instead, manufacturers must conduct systematic biological risk assessment to determine when biocompatibility testing is necessary, which tests are appropriate, and how to justify those decisions scientifically. For medical device manufacturers

Biocompatibility is straightforward at its core: your device materials must not cause an unacceptable biological response in the body under their intended use conditions. In practice, that means you need to understand how your device contacts the body, for how long, what biological hazards exist, and how you'll demonstrate that biological risks are acceptable. What FDA Biocompatibility Requirements Actually Cover FDA uses biocompatibility evaluation to judge whether your devi

On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a groundbreaking initiative designed to accelerate Medicare beneficiary access to FDA-designated Breakthrough Devices. Combined with the expanding Total Product Life Cycle Advisory Program (TAP), these programs fundamentally change how manufacturers should approach development strategy, evidence gen