IVD Special – Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.

In our fourth episode of NAMSA’s RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).

During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.

“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal Regulatory Consultant-IVD)

Discussion topics include:

What criteria classify a device as either SiMD or SaMD for IVDs?
What regulatory agencies are taking the lead on future IVD regulations?

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management. Rich started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Linford Leitch

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.

Sonia Lecce, MBA

Sonia is a regulatory affairs expert with over 22 years of experience in introducing new products into multiple regions, including Canada, Japan, Brazil and the United States. She has led multi-country submissions and is well-versed in communications with global regulatory bodies. Sonia has worked with organizations such as Sysmex America, Baxter Healthcare, Catalent Pharmaceuticals and Abbott Molecular. She has an MBA from Keller Graduate School of Management and a Bachelor of Science in Biology from the University of Illinois at Chicago. Recently, she completed a 510(k) Hematology analyzer submission, assembled a 510(k) blood banking project with Biological License Applications (BLAs) and U.S. Food and Drug administration (FDA) interaction, achieved breakthrough designation for oncology diagnostic novel technology and supported pre-submissions for CDx devices.

Duan Threats

Duan is an experienced professional in the In Vitro Diagnostic (IVD) devices industry, with expertise in regulatory compliance and labeling for various IVD devices. He has worked with companies like Sysmex, Abbott Molecular and MABIS DMI Healthcare before joining NAMSA in 2020. Duan’s core competencies include compliance with FDA, Canada and Latin America regulations, creating regulatory assessments and ensuring labels are compliant with international regulations. His recent projects involve regulatory change control assessments, laboratory developed test regulatory assessment, and surveying labeling and registration requirements of Asia-Pacific regional countries.