Jennifer GoodeBiocompatibility Program Advisor, Office of Product Evaluation and Quality (OPEQ) at FDA, Center for Devices and Radiologic Health (CDRH)
Jennifer L. Goode, BS, Biomedical Engineer has served as the Biocompatibility Program Advisor for OPEQ (formerly ODE) since 2015, and most recently has been providing biocompatibility technical and regulatory policy input for the ASCA Biocompatibility Testing Laboratory Accreditation process. Ms. Goode began her career at CDRH in 1994, as a premarket reviewer responsible for the review of medical devices and combination products for obstetrics and gynecology treatment, and surgical and interventional treatment of the peripheral vasculature, as well as cardiac monitoring, pacing, and neurology devices. Beginning in 2007, Ms. Goode served as an FDA liaison to and International Expert for several ISO Working Groups responsible for the development of international standards for the biocompatibility evaluation of medical devices, including ISO 10993-1, ISO 10993-4, and ISO 10993-18. Since 2017, Ms. Goode has represented CDRH on the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a committee responsible for coordination of review and acceptance of fit for purpose new or revised toxicology test methods that reduce, refine, or replace the use of animals. In 2018, Ms. Goode was selected as FDA’s Alternate Agency Representative to ICCVAM. Since 2018, Ms. Goode has also served as the CDRH regulatory expert for the USP Biocompatibility Expert Panel tasked with revision of General Chapters <87>, <88>, and <1031>, and in 2020, she was identified as an expert government liaison to USP’s Packaging Expert Committee. Since 2018, Ms. Goode has also served as the regulatory co-chair for the US AAMI Biological Evaluation (BE) mirror committee to ISO/TC 194. The AAMI/BE committee is responsible for coordinating US positions on all ISO standards related to biocompatibility evaluation of medical devices. Since 2008, Ms. Goode has also served as one of two OPEQ representatives to the Biocompatibility Standards Task Group (STG) at CDRH. This Biocompatibility STG is responsible for coordinating FDA input to, and scientific review and recognition of all biocompatibility standards used by CDRH.