San Francisco Bay Area Chapter Hybrid Event: Top 3 Mistakes to Avoid in your 510(k) Submission to the FDA or Third Party

Michael E. Adjodha
M.ChE., CQIA | Supervisory Chemical Engineer | Assistant Director| Center for Devices and Radiological Health (CDRH) | U.S. Food and Drug Administration (FDA)

Michael has 29 years of experience as an engineer in the Federal Government, including 25 years with FDA’s Center for Devices and Radiological Health. His experience includes 22 years as a medical device reviewer of dental devices with FDA, and experience as a project manager with the U.S. Nuclear Regulatory Commission, and a Patent Examiner with the U.S. Patent and Trademark Office. As a reviewer for FDA, Michael reviewed over 1000 510(k) submissions for dental restorative and prosthetic devices, evaluated numerous 513(g) classification requests and PMA 30-day notices, and provided SME support to FDA field offices regarding compliance and enforcement actions. He also authored or co-authored several device-specific guidance documents, including dental composite resins, dental amalgam, noble metal alloys, base metal alloys, bone grafting materials, light activators, oral scanners for CAD/CAM, temporary mandibular condyle devices, and denture base resins. His work also involved preparing responses to Citizen Petitions and developing environmental assessments for agency-initiated actions. Currently, he supervises the Restorative and Surgical Dental Devices Team within the Division of Dental and ENT Devices with CDRH where he provides oversight and direction for reviews and decisions on 510(k), IDE, De Novo, Q-Sub, and 513(g) submissions.

Melissa Hall
Policy Analyst | 510(k), De Novo, 513(g), Device Determinations & Custom Devices Lifecycle Team | Office of Regulatory Programs (ORP) | Office of Product Evaluation and Quality (OPEQ) | Center for Devices and Radiological Health (CDRH) | U.S. Food and Drug Administration (FDA)

Melissa Hall is currently a 510(k), 513(g), Device Determination Program Expert in the Office of Regulatory Programs (ORP) within the Center for Devices and Radiological Health (CDRH). Her work focuses primarily on interpreting, updating, and developing policy related to both 510(k) and 513(g) submissions. In addition, she serves as the lead for the CDRH Third Party 510(k) program.

Melissa began her career at FDA in 2013 as a lead reviewer focused primarily on the review of spinal devices. She then served as the Assistant Director for the Spinal Devices Division within CDRH providing leadership and serving as an expert in the guidance, regulation, and review of spinal devices. Prior to her current role she worked as a consumer safety officer in the Division of Industry and Consumer Education (DICE) educating external stakeholders about the various regulatory resources and requirements established by FDA.

Before joining the FDA, Ms. Hall worked at the USPTO reviewing orthopedic devices patents. She received her Master of Science in Biomedical Engineering at the New Jersey Institution of Technology (NJIT), and a Bachelor of Science in Biological Sciences from the University of Maryland Baltimore County (UMBC).

Stephanie M. Fitts
PhD | Vice President, Global Quality and Regulatory Affairs at Align Technology

Stephanie is the Vice President, Global Quality and Regulatory Affairs, at Align Technology, a global medical device company focused on dental devices. She has served in this role since 2019 and leads the global regulatory and quality functions for all manufacturing sites and business units.

Prior to Align, Stephanie served as Vice President at TransEnterix, Inc., a medical device company focused on the use of robotics to improve minimally invasive surgery. Here, she was responsible for global strategy and management of regulatory affairs, clinical research, and quality assurance programs. Stephanie previously served in Regulatory and Quality leadership positions Baxano Surgical, Inc. (formerly TranS1, Inc.), Stryker Orthopedics and Medtronic, Inc.

Stephanie earned a PhD in Bioengineering from Pennsylvania State University and a BS in Engineering Science from the University of Virginia.

Prabhu Raghavan
MS, MBA | Principal Consultant, MDQR Solutions | UCSC Extension Instructor, SaMD

Prabhu is a quality and regulatory professional with over 20 years of experience in medical devices and has held senior leadership positions in both startups and large organizations. He is currently the Principal Consultant at MDQR Solutions, boutique consulting company focusing on providing regulatory affairs and quality engineering services for medical device startups. He is also an instructor for regulatory affairs at University of California, Santa Cruz. Previously, he was the VP of Regulatory and Quality at AliveCor, a startup utilizing artificial intelligence to help patients manage their arrhythmia. Prior to AliveCor, Prabhu was an executive at Jan Medical, a startup focused on noninvasively detecting brain abnormalities, and at Stryker, where he held several senior leadership roles in regulatory affairs and quality assurance. Prabhu started his career developing machine learning algorithms at Bell Laboratories. Prabhu has 5 issued patents. He has a Master of Science in Electrical Engineering from Rutgers University and a joint MBA from University of California, Berkeley/Columbia University.

Prithul Bom
CEO, Regulatory Technology Services (RTS) Third Party Review Organization (3PRO) | PhD Candidate

I have 22 years of healthcare, medical device, biotech and IVD industry experience, starting with my career as a software developer in 1998 at Lawson Software, Infor. In addition to software development (Infor), I have served in Business Development (Johnson & Johnson, RCRI, WMDO), Scientific Affairs and Global Head of Regulatory Affairs (Theorem, Chiltern), and Executive Strategist - Medical Device & Diagnostics (Covance, Labcorp). My managerial experience includes managing regulatory scientists in Asia, Europe and North America. I have authored and or managed numerous 510(k), IDEs, de novos, and clinical development plans / protocols. I have led and or supported numerous FDA meetings which include Q-submissions, and pre-IND and IDE meetings. As the Executive Lead, I have overseen numerous Phase I-IV clinical studies (radionuclides, contrast media). My specific scientific and regulatory experience since 2013 has been in general imaging modalities including reviewing 510(k) and managing diagnostic contrast agents and radionuclides studies for MR, PET, SPECT, X-ray, CT, Ultrasound, EEG, and Near Infrared.

Surina Gulati
Senior Quality Systems & Compliance Engineer at Align Technology | RAPS SF Chapter Leadership

Surina has over 5 years of quality and regulatory experience in the medical device industry. She currently serves as a member on the SF RAPS Chapter Leadership team. Surina works as a Senior Quality Systems Engineer at Align Technology Inc. Prior to Align, Surina worked for a Stanford StartX AI/ML Medical Device Start-up after completing her MS from Johns Hopkins University in Biotechnology & Entrepreneurship. Surina started her career at Thermo Fisher Scientific, in the BioProduction Division after graduating from University of California Berkeley.