Medical Device Biomaterials Supplier Liability Issues - FDA Regulation and Managing Risk

Why Should You Attend:

Many companies are intrigued by the business potential of supplying components and raw materials to the medical device industry. However, these companies are also wary of the Food and Drug Administration's (FDA's) regulatory requirements and their potential liability exposure should a patient be harmed by the finished device, especially implants and other high-risk devices.

This session is designed for specialty and commodity chemical/materials producers. It will provide an overview of FDA's regulation of device component/raw materials, explain the statutory liability protections in place for suppliers of materials for medical devices, and discuss other techniques for managing/limiting risk. The information presented here will allow suppliers to make better-informed decisions about entering the medical device market (or expanding their current participation to include new types of devices).

Areas Covered in this Webinar:

• General supplier liability considerations
• Qualifying for the protections of the Biomaterials Access Assurance Act of 1998
• Supplier protection that may be available based on FDA’s review of the finished device
• Additional strategies biomaterials suppliers can consider to manage risk, including:
  • Contractual indemnification
  • Insurance provisions
  • Evaluating customers’ financial health
  • Other “soft” factors to assess