Sarah B. Nelson has been in the regulatory industry for over 10 years, with a focus on medical devices in Orthopedics, Regenerative Medicine and In Vitro Diagnostics.

Prior to joining NAMSA, Sarah started at the U.S. Food and Drug Administration (FDA) as a Commissioner’s Fellow in Regenerative Medicine and continued as Lead Reviewer and Senior Lead Reviewer for the Division of Orthopedic Devices. She led multidisciplinary teams on complex reviews of Orthopedic Devices and Combination Products. Sarah has also held regulatory affairs specialist and management positions with Siemens Healthineers where she developed global (US, EU, China and Japan) regulatory strategies for In Vitro Diagnostic (IVD) devices throughout the total product lifecycle. Sarah holds a Master of Science in Biomedical Engineering from the University of Connecticut.

CORE COMPETENCIES

• Evaluating and managing a wide range of FDA submission types including 510(k), pre-submission, IDE, PMA, De Novo and EUA
• Experience with submissions as both an FDA Lead Reviewer and author/submitter
• Conducting reviews of novel device or device combination product classification through pre-submission, 513(g) and Request for Designation (RFD)
• Leading multidisciplinary teams developing regulatory assessments, strategy and submissions
• Developing regulatory strategies and assessment to support global marketing plans including key regions such as US, EU, Asia Pacific and Latin America
• Experienced with quality management systems in accordance with ISO13485 and 21 CFR 820
• Providing regulatory impact assessments in accordance with design control procedures and documentation to support submissions and audits with global regulatory bodies

RECENT PROJECTS

• Managed global regulatory strategy of laboratory diagnostic instruments and associated assays of varying device classifications and submissions including EU IVDR, FDA pre-submissions, 510(k)s and PMAs
• Led a multidisciplinary team at FDA in assessment of standard development and testing procedures for novel orthopedic implant claims

PUBLICATIONS

• Nguyen AK, Nelson SB, Skoog SA, et al. Effect of simulated body fluid formulation on orthopedic device apatite-forming ability assessment. J Biomed Mater Res. 2023; 111(5): 987-995. doi:10.1002/jbm.b.35207