Medical Device Biomaterials Supplier Liability Issues - FDA Regulation and Managing Risk This webinar on biomaterials supplier issues will cover strategies to minimize and manage the potential liability risks associated with supplying crucial materials to the medical device industry. It will cover statutory liability protections available for suppliers and how to manage risk based on FDA’s review of finished device.
Description 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:
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Contractual indemnification Insurance provisions Evaluating customers’ financial health Other “soft” factors to assess
Who Will Benefit: This webinar is intended for companies that supply components and raw materials to the medical device industry. Included are OEM manufacturers, chemical, glass and plastic manufacturers, electronics and electrical parts suppliers. The following personnel will benefit: In-house counsel Regulatory affairs managers Corporate risk managers Sales/marketing directors The following personnel from medical device companies will also benefit: Legal/ in-house counsel Purchasing Supply chain Raw material QA Senior management Instructor Profile: Frederick A. Stearns, is a partner in the law firm of Keller and Heckman LLP’s Washington, DC, office, where his practice involves a wide range of issues facing manufacturers of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics. He helps product manufacturers evaluate the need for marketing approval from FDA, pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). Mr. Stearns also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns works with companies to conduct FDA due diligence reviews, both for internal control/compliance assessment purposes and as part of product line or corporate acquisitions. He is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, dietary supplements, and cosmetics. Mr. Stearns received his B.S. in Applied and Engineering Physics from Cornell University in 1988 and his J.D. with honors from The George Washington University Law School in 1993. He is a member of the District of Columbia and Virginia Bars.