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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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Erica, Sablan, RAC Avatar

Erica Sablan, RAC

As Senior Director of IVD Regulatory Consulting at Precision, Erica brings over 30 years of experience supporting the development of in vitro diagnostics, including molecular diagnostics, next-generation sequencing, and companion diagnostics. Her expertise spans the full IVD lifecycle—from RUO to IVD and DTC genetic testing—and includes analytical and clinical study design, U.S. FDA submissions (Q-Submissions, IDEs, De Novo, 510(k), PMA, and BLA), and EU IVDR CE-IVD registrations and Annex XIV performance study submissions. She has supported both startups and global diagnostic organizations and regularly serves as the client representative in FDA and EU Notified Body interactions.
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