Medical Device Submissions Workshops – 510(k) and De Novo
510(k) and De Novo Submissions Workshop: February 3-4, 2025
IDE Submissions Workshop: February 5, 2025
PMA Submissions Workshop: February 6-7, 2025
Gain exclusive access to FDA and industry experts who will guide you through the critical medical device submissions process step-by-step during our hybrid workshops!
Medical Device Submissions Workshops – 510(k) and De Novo
510(k) and De Novo Submissions Workshop: February 3-4, 2025
IDE Submissions Workshop: February 5, 2025
PMA Submissions Workshop: February 6-7, 2025
Medical Device Submissions Workshops – 510(k) and De Novo
510(k) and De Novo Submissions Workshop: February 3-4, 2025
IDE Submissions Workshop: February 5, 2025
PMA Submissions Workshop: February 6-7, 2025
Join us in February for our three back-to-back, Medical Device Submissions Workshops, including: 510(k) and De Novo; Investigational Device Exemption (IDE); Premarket Approval (PMA)! We’re excited to offer a hybrid experience that includes a virtual and in-person option in our Washington, D.C. office! The hybrid format allows us to offer a more comprehensive and interactive experience, while providing the same access to real-world case studies, tips and best practices directly from the FDA and leading industry experts.
These workshops are instrumental in guiding professionals through the intricate world of medical device submissions, so if you’re new to medical device regulatory affairs, or looking to strengthen your foundational knowledge, this is the perfect program for you.
Who should attend?
- Medical device professionals new to the FDA regulatory submission process
- Regulatory Affairs Professionals
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Regulatory Affairs Rotational Associates
View the 2024 510(k) and De Novo agenda below. Join the mailing list to receive the latest news and updates on the 2025 Workshops.
*Download the 2024 IDE and PMA agendas.
510(k) Submissions Workshop
*Schedule reflects Eastern Time
Day 1
| 8:30 – 9:00 am | Registration Check-In and Continental Breakfast |
| 9:00 – 9:05 am | Welcome and Introductions |
| 9:05 – 10:30 am | The Law and Regulations Sally Maher, Regulatory Consultant, Sally Maher Consulting – 510(k) definition – 510 and 513 FDCA – Guidance for 510(k): general & product specific – How to find it – How to use it – Different types of 510(k)s; which to use – Review of bundling 510(k)s – FDA Product Codes – Activity |
| 10:30 – 10:45 am | Break |
| 10:45 pm – 12:00 pm | 510(k) Strategy and Planning Tony Blank, Senior Director of Regulatory Affairs, AtriCure – Staff involved – Role of each function – RA responsibilities – Use of guidance – Global considerations – Pre-submissions – Predicates – Breakthrough Devices Program – Safer Technologies Program |
| 12:00 – 1:00 pm | Networking Lunch |
| 1:00 – 2:15 pm | Preparing the Submission Jemina Jay Dedania, Director of Regulatory Affairs, Global Regulatory, Hogan Lovells Melissa Hall, Founder and Principal Consultant, Stratera Regulatory Consulting – General information including how to select a predicate device – Assembling the 510(k) – eCopy – eSTAR |
| 2:15 – 2:30 pm | Break |
| 2:30 – 3:15 pm | The FDA Review Process Angela DeMarco, Biomedical Engineer, Center for Devices and Radiological Health, FDA – How it works at FDA – FDA/industry interactions – Refuse to Accept – Submission Issue meetings – FDA holds – Interactive review – Least Burdensome flag – Current pilots |
| 3:15 – 3:30 pm | Break |
| 3:30 – 4:00 pm | CDRH Ombudsman’s Office Ken Skodacek, Center for Devices and Radiological Health, Deputy Ombudsman, FDA – Roles & Responsibilities – Appeals Process |
| 4:00 – 5:00 pm | Networking Reception |
Day 2
| 8:30 – 9:00 am | Continental Breakfast |
| 9:00 – 10:15 am | Clearance: Launch and After Tony Blank, Senior Director of Regulatory Affairs, AtriCure – What clearance does and does not mean – Promotional practices for 510(k) devices – FDA – FTC – Complaint Handling and MDRs – When to File a New 510(k) for Device Modifications – Catch-up 510(k)s |
| 10:15 – 10:30 am | Break |
| 10:30 – 11:00 am | De Novo Quynh Hoang, Senior Regulatory Consultant, FDA and Life Science Practice, King & Spalding – Definition of a De Novo – Final Rule on De Novo – When De Novo is used – Differentiation from 510(k) |
| 11:00 – 11:30 am | Regulatory Strategy for De Novo Holly Drake, Director, Regulatory Affairs – Medical Devices, Dexcom Raffy Brown, Regulatory Affairs – Medical Devices, Dexcom – Key eligibility criteria – Benefit-risk analysis |
| 11:30 am – 12:00 pm | Preparing the De Novo Submission Holly Drake, Director, Regulatory Affairs – Medical Devices, Dexcom Raffy Brown, Regulatory Affairs – Medical Devices, Dexcom – Content – Assembling the submission |
| 12:00 – 1:00 pm | Networking Lunch |
| 1:00 – 1:30 pm | FDA Review Process for De Novo Pooja Panigrahi, FDA – Use of Pre-Submission meeting – Rationale for De Novo – Clinical Protocols – Special Controls |
| 1:30 – 2:00 pm | Maintenance of a Granted De Novo Pooja Panigrahi, FDA – Post-market requirements – Classification Order – De Novo database, granting order, decision summary – Use as a predicate – Making changes to granted De Novo device |
| 2:00 – 2:15 pm | Break |
| 2:15 – 4:15 pm | Applied Learning and Breakout Discussions Quynh Hoang, Senior Regulatory Consultant, FDA and Life Science Practice, King & Spalding – 510(k) & De Novo Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies & Key – – Takeaways – Regroup for Q&A |
| 4:15 pm | Adjournment |
Reference our 2024 speakers below until the 2025 experts are announced. Stay updated by joining the mailing list.
510(k) and De Novo Speakers
Raffy Brown, Director, Regulatory Affairs – Medical Devices, Dexcom
Raffy Brown is a director of regulatory affairs at Dexcom, Inc. with over 25 years of experience in the pharmaceutical and medical device industries. Her areas of expertise include global medical device and combination product regulations related to vascular therapies and diabetes management. She has a master’s degree in chemistry from the University of Kansas.
Jemin Jay Dedania , Director of Regulatory Affairs, Global Regulatory, Hogan Lovells
Jemin Dedania assists clients with regulatory and policy issues, with a focus on U.S. Food and Drug Administration (FDA) medical device and combination product strategies. He advises medical technology companies on matters related to life cycle management, promotional issues, and compliance, and provides general advice on navigating FDA’s regulatory framework.
Angela DeMarco, Assistant Director of the 510(k), De Novo, 513(g), Device Determinations and Custom Devices Lifecycle Team, ORP, CDRH
Angela DeMarco is currently the Assistant Director of the 510(k), De Novo, 513(g), Device Determinations and Custom Devices Lifecycle Team in the Office of Regulatory Programs (ORP) within the Center for Devices and Radiological Health (CDRH). She was with the 510(k) team for 6 years prior to assuming the role of Assistant Director. Her work focuses primarily on interpreting, updating, and developing policy related to premarket submissions.
Holly Drake, Director, Regulatory Affairs – Medical Devices, Dexcom
Holly Drake is a director of regulatory affairs at Dexcom, Inc. with 18 years of experience in the medical device industry. Her areas of expertise include medical device regulations, regulations and guidance on medical software applications, and clinical studies related to diabetes management. She has a Bachelor of Science degree in biomedical-mechanical engineering from the University of Southern California.
Melissa Hall, Founder and Principal Consultant , Statera Regulatory Consulting LLC.
Melissa is a seasoned medical device regulatory expert with over 10 years experience at the FDA. She has held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. Her review expertise ranges across all premarket submission types, with a specific focus in the orthopedic device space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes, and as a policy analyst, she served as a regulatory expert addressing complex regulatory issues and ensuring laws, regulations, and guidances were applied consistently across the center. Now serving as a consultant, she continues her dedication to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategy that best aligns with their business goals.
Quynh Hoang, Consultant, FDA and Life Sciences, King & Spalding
Quynh Hoang is a senior regulatory consultant in the FDA and Life Sciences practice of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process for medical devices and combination products with a device constituent part (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as, in the FDA’s postmarket process for adverse signals.
Sally Maher, Regulatory Consultant, Sally Maher
Sally Maher is the founder of the consulting group S Maher Consulting, a premier medical device consulting organization. Ms. Maher served on the Board of Directors for ACell Inc. Previously she served as the interim Chief Operating Officer for ACell Inc. Before that she was Vice President of Regulatory and Clinical Affairs at Edwards Lifesciences, Critical Care. She has more than 30 years of medical device and combination product experience in regulatory, clinical, reimbursement, healthcare compliance, and product development.
Ken Skodacek, Center for Devices and Radiological Health, Deputy Ombudsman, FDA
Ken Skodacek has been working with medical devices for over 30 years and serves as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH). In this role, Ken provides a confidential, independent, and impartial resource that informally investigates complaints and resolves disputes. He typically prevents and resolves misunderstandings through candid conversations and facilitated meetings with external stakeholders and FDA staff. The CDRH Ombudsman Program also ensures fair and efficient processing of appeals of CDRH decisions. Outside of his responsibilities at FDA, he has served as the Co-Chair of the American Bar Association’s Ombuds Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association.
PMA Submissions Speakers
Jhumur Banik, Policy Analyst, Biomedical Engineer at FDA
Jhumur Banik, MS, PMP is a Policy Analyst with the PMA, HDE, Q-Submission and Device Tracking Lifecyle (PHQ) Team in the Division of Submission Support (DRP1), Office of Regulatory Programs (ORP) in FDA/CDRH. She is involved in policy development and providing her regulatory and technical expertise on PMAs, PMA GMP, and Q-submissions for internal and external stakeholders among various other duties.
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific
Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions.
Jacob Dyer, Senior Regulatory Officer, FDA
LCDR Jake Dyer is a Senior Regulatory Officer in the Regulatory Inspections and Audits Team at CDRH’s Office of Regulatory Programs. He is currently serving as a Program Analyst and Assessor for the Medical Device Single Audit Program (MDSAP) where he leads efforts associated with MDSAP development and implementation with other regulatory authorities and industry. Jake began his career with the FDA over 8 years ago as an FDA Medical Device Investigator and is a licensed Professional Engineer, Lean Design for Six Sigma Black Belt, Certified Project Management Professional (PMP), Certified Quality Auditor, and a level 2 certified FDA medical device investigator. LCDR Dyer earned his degree in Mechanical Engineering from the University of Rochester and Master of Science Degree from Eastern University.
Jessica Ringel, Partner, FDA and Life Sciences, King & Spalding
Jessica Ringel advises medical device and other life sciences manufacturers and distributors on matters spanning the entire FDA regulatory lifecycle. She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.
Monica Montanez, MS, RAC, CQA, Principle Strategy Consultant – Regulatory
Monica Montanez has over 25 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals. Monica began her medical device career with Millar Instruments and then with Cyberonics (now Liva Nova), CONMED, Generic Medical Devices, Inc, Cochlear and before joining Medtronic in 2010. With NAMSA, Monica then moved into consultancy where the focus of her work has always been working with manufacturers with complex submissions for novel devices.
IDE Submissions Speakers
Amrin Chowdhury, MS, Health Scientist , FDA
Amrin Chowdhury is a Health Scientist for the Division of Clinical Policy and Quality and within the Office of Clinical Evidence and Analysis (OCEA) at the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). She joined the FDA in 2022 serving as a Policy Analyst within OCEA. Prior to joining the FDA, Amrin served as a Project Manager at the Foundation of the National Institutes of Health (FNIH). She was part of a team overseeing a major non-small cell lung cancer (NSCLC) umbrella clinical trial, Lung-MAP.
Kristin Duggan, Partner, Global Regulatory, Hogan Lovells
With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For over 20 years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products.
Anne Talley, Chemical Engineer, FDA
Anne Talley is a Chemical Engineer in the Division of Clinical Policy and Quality within the Office of Clinical Evidence and Analysis (OCEA) in the Center for Devices and Radiological Health (CDRH) at FDA. Anne has over 7 years of experience at FDA, both as a Lead Reviewer/Team Lead in the Office of Orthopedic Devices (OHT6) and within OCEA.
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