Bringing a medical device to the U.S. market means more than selecting a regulatory pathway. Your specific role shapes how you plan, generate, and defend biocompatibility and toxicological data within the FDA framework. Understanding Your Role in the Medical Device Approval Process Medical Device Manufacturers Manufacturers need a clear biocompatibility and toxicology strategy that starts at design input. Key challenges include: Translating intended use and contact duration

Medical device regulation in the United States sits squarely under the authority of the Food and Drug Administration, within the Center for Devices and Radiological Health (CDRH). If you plan to market a device in the U.S., you operate within this framework whether your product is a simple external accessory or an implantable system with long term patient contact. CDRH implements federal laws such as the Federal Food, Drug, and Cosmetic Act (FD&C Act) through binding regulat

Extractables and leachables analysis sits at the core of modern biocompatibility assessment for medical devices. If your device uses polymers, adhesives, colorants, tubing, coatings, or packaging, you are dealing with potential chemical migrants that regulators expect you to understand and control. What Are Extractables and Leachables? Extractables  are chemical constituents that move out of a device or material under aggressive laboratory conditions, such as exaggerated temp

Material selection is one of the most critical decisions in medical device design, directly impacting both device performance and patient safety. For design engineers, understanding biocompatibility considerations during material selection can prevent costly redesigns, reduce testing iterations, and accelerate regulatory approval. This guide provides design engineers with practical biocompatibility considerations for selecting materials that meet both functional and biologica

Medical device biocompatibility evaluation is complex, and even experienced manufacturers can make costly mistakes that result in regulatory delays, additional testing requirements, and extended time-to-market. Understanding these common pitfalls can help you avoid them and streamline your path to approval. Based on extensive experience with regulatory submissions, here are the most frequent biocompatibility testing mistakes that cause approval delays—and how to prevent them.

Navigating the complex world of medical device biocompatibility can be overwhelming for manufacturers. With stringent regulatory...

When it comes to manufacturing medical devices, ensuring safety and compliance is paramount. Navigating complex regulatory landscapes can...