FDA Regulatory Science Lecture: Overview of the PMA Process
Thursday, November 14, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
This seminar was originally postponed due to the government shutdown.
Overview of the PMA Process
Senior Manufacturing Reviewer
Division of Cardiovascular Devices
This lecture will explain what a PMA is and how it is different from a 510(k). We will also discuss the elements contained in the submission, the FDAs review, and post-market requirements.
About the Speaker
Lindsay Pack has been with FDA for a little over two and a half years. She began at FDA as a lead reviewer/biomedical engineer for peripheral vascular devices. Additionally, since 2012, she has served as the Senior Manufacturing Reviewer for the Division of Cardiovascular Devices where she reviews information related to manufacturing changes of PMA devices, annual reports, and recalls. Prior to joining FDA, Lindsay spent 7 years in the medical device industry at Bard Peripheral Vascular, Inc.. During that time she worked and lived both in the US and Germany and facilitated approval of multiple PMAs, Supplements, IDEs, and 510(k)s. Her last four years at Bard were spent as a manager of a regulatory affairs team working on pre and post- market issues for Class II and Class III devices. Lindsay holds a Bachelors of Science in Engineering for Biomedical Engineering with a Pre-Med emphasis from Arizona State University.