Medical Device Submissions Workshops – 510(k) and De Novo
8:30 am – 4:15 pm ET
February 3-4, 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
8:30 am – 4:15 pm ET
February 3-4, 2025
Medical Device Submissions Workshops – 510(k) and De Novo
8:30 am – 4:15 pm ET
February 3-4, 2025
AdvaMed is proud to host the Medical Device Submissions Workshops: 510(k) and De Novo in February 3-4, 2025! Choose to attend virtually or in person at AdvaMed’s Washington, D.C. office, where FDA officials and industry experts will provide essential guidance through the 510(k) and De Novo submission processes. Understanding the IDE process from start to finish will help reduce errors and ensure compliance with all FDA requirements. By attending this in-depth workshop, medtech professionals are better equipped to meet regulatory demands and bring their devices to market faster.
Join us to get your questions answered, discuss specific challenges, and gain expert insights into the 510(k) and De Novo application requirements to gain a deeper understanding of this essential regulatory pathway. Don’t miss this opportunity to enhance your regulatory knowledge and connect with your fellow regulatory peers!
Who should attend?
These workshops are valuable for anyone aiming to streamline the regulatory process, reduce submission risks, and confidently bring their device to market such as:
- 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 preliminary 2025 510(k) and De Novo agenda below or download it here.
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Day One
*Schedule reflects Eastern Time
| Time | Session |
|---|---|
| 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 am – 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 Jemin Jay Dedania, Director of Regulatory Affairs, Global Regulatory, Hogan Lovells Melissa Hall, Founder and Principal Consultant, Statera 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 |
Day Two
| Time | Session |
|---|---|
| 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 Elaine Tseng, Counsel, King & Spaulding – 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 Ginny Hu, Director, Regulatory Affairs, Dexcom – Key eligibility criteria – Benefit-risk analysis |
| 11:30 am – 12:00 pm | Preparing the De Novo Submission Bryan Osborne, Senior Director, Regulatory Affairs, 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, Policy Analyst, FDA Peter Yang, De Novo Program Lead, Office of Regulatory Programs, Office of Product Evaluation, Center for Devices and Radiological Health, 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 Peter Yang, De Novo Program Lead, Office of Regulatory Programs, Office of Product Evaluation, Center for Devices and Radiological Health, 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 *In person participants, only – 510(k) & De Novo Recap – Facilitated Breakout Group Deep Dive – Hypothetical Case Studies & Key Takeaways – Regroup for Q&A |
| 4:15 pm | Adjournment |
Join medical device submissions experts and FDA officials who will provide essential guidance through the 510(k) and De Novo submission processes.
Meet the Speakers
Tony Blank, Senior Director of Regulatory Affairs, AtriCure
Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired).
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.
Jemin has worked with combination products and medical devices since completing his master’s thesis in biomedical engineering, in which he focused on novel growth factor technologies in bone healing. Upon graduating from the New Jersey Institute of Technology, he was a lead reviewer, and later a team lead, at FDA’s Center for Devices and Radiological Health in the Division of Orthopedic Devices (now the Office of Health Technology 6) for nearly eight years. He then transitioned to Stryker, where he served as a specialist and later manager in the Regulatory Affairs department. At Stryker, Jemin developed regulatory strategies for new product development projects, authored regulatory submissions, provided guidance on novel combination product submissions, interfaced with notified bodies, led advertising and promotion reviews, supported mergers and acquisition due diligence and integration efforts, and developed his staff.
Angela DeMarco, Biomedical Engineer, Center for Devices and Radiological Health, FDA
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.
Angela began her career at FDA as a research fellow performing literature reviews for medical devices, aided in the preparation of advisory panel meetings, and coordinated registry workshops. She then worked as a senior lead reviewer focused primarily on the review of neurorehabilitative devices before transitioning to policy work that informs how the FDA regulates medical devices and conducts premarket reviews.
Melissa Hall, Founder and Principal Consultant, Statera Regulatory Consulting
Melissa is a seasoned regulatory affairs professional with 11 years of experience, specializing in Food and Drug Adminstration (FDA) regulations for medical devices. As a former-FDA reviewer, manager, industry educator, and policy analyst, she has a deep understanding of the Agency’s position and regulatory pathways. In her current role as a regulatory consultant and advisor, she assists companies in preparing effective regulatory submissions and offers strategic communication with the FDA. Continuing her passion for industry education, Melissa is an active RAPS member who has spoken at various RAPS conferences, including most recently, RAPS Convergence about effectively utilizing eSTAR. She also serves as a regulatory advisor to various MedTech start-up companies in the Larta accelerator program. She has experience assisting clients in the cardiovascular, orthopedic, spine, ENT, ophthalmology, dental, and imaging medical device spaces.
Ginny Hu, Director, Regulatory Affairs, Dexcom
Ginny leads the RA team for digital health regulatory affairs efforts for software based products and solutions at Dexcom, including US/OUS software, data platform, APIs and data product regulatory classification, registration/approval and sustaining. Ginny’s RA team also manages partnerships and cybersecurity regulatory efforts. Her team continues to support all regulatory activities, including US/OUS regulatory pathway, breakthrough device designation, IDE, Q-subs and 510(k) submissions associated with Dexcom’s New Market initiatives.
Sally Maher, Regulatory Consultant, Sally Maher Consulting
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.
Prior to joining Edwards, Ms. Maher held various Senior Vice President roles at Smith & Nephew’s Advanced Surgical Products Division including: Regulatory and Clinical Affairs, Reimbursement and Healthcare Economics, Healthcare Compliance, Research and Development, and New Business Development. Prior to Smith & Nephew, Ms. Maher worked in regulatory, quality, and clinical roles for various organizations including Johnson & Johnson, Pfizer, and the US Food and Drug Administration. She received a bachelor’s degree from Ohio Wesleyan University, and a law degree from the University of Baltimore.
Pooja Panigrahi, Policy Analyst, FDA
Pooja Panigrahi is a Policy Analyst with the 510(k), De Novo, 513(g), Device Determination and Custom Devices Lifecycle Team in CDRH’s Office of Regulatory Programs at FDA. Her work focuses on analyzing, developing, and communicating policy related to De Novo submissions. Pooja began her career at FDA in 2015, previously serving roles as a biomedical engineer/lead reviewer and team lead within the office of orthopedic devices before transitioning to policy work. She obtained her PhD degree in biomedical engineering from Clemson University, and her master’s and bachelor’s degree in materials science and engineering from Northwestern University.
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.
He previously served in the Center’s Clinical Trials Program, where he led the development and implementation of policies and programs intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process.
Elaine Tseng, Counsel, King & Spaulding
Elaine Tseng focuses on regulatory matters in the area of life sciences. A partner in our FDA and Life Sciences practice, Elaine represents medical device, pharmaceutical and other life sciences sector clients in a variety of regulatory strategy, approval, marketing, compliance and enforcement matters.
Elaine primarily represents clients in matters involving the Food and Drug Administration. She provides proactive regulatory strategy and compliance counseling, including in the areas of FDA marketing clearance/approval and exemptions, clinical studies and product development, adverse event reporting, recalls, and other pre- and post-market compliance obligations. Elaine advises on managing FDA inspections, responding to FDA-483s and warning letters, interacting with FDA on compliance and product review matters, pursuing regulatory appeals and petitions and participating in FDA Advisory Committee deliberations. Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions, handling internal investigations involving FDA issues, and conducting audits and assessments of compliance with FDA requirements regarding quality systems/cGMP, clinical trials, and marketing and promotion. She also advises companies on structuring business transactions and ventures to minimize regulatory risk and potential compliance concerns.
Peter Yang, De Novo Program Lead, Office of Regulatory Programs, Office of Product Evaluation, Center for Devices and Radiological Health, FDA
Peter Yang currently serves as the program lead for the De Novo Program within the Office of Regulatory Programs, Office of Product Evaluation and Quality at the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). As the De Novo Program Lead, he oversees the program and provides scientific and regulatory oversight for all De Novo requests across the Center. Before becoming the program lead, Peter was a policy analyst within the De Novo Program for four years. He started his FDA career first as an ORISE postdoc and then as a medical device reviewer in the Division of Surgical Devices. Peter’s background is in bioengineering – specifically tissue engineering and regenerative medicine, and more specifically tendon/ligament tissue engineering. He obtained his PhD from Georgia Tech in 2011.
Attendees joining us in person will come to AdvaMed’s office located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.
This event is offered both virtually and in-person to maximize convenience. Please note that in-person and virtual pricing is the same.
Check to see if your company is an AdvaMed member here.
- AdvaMed Member: $1,600
- AdvaMed Accel Member: $850
- Non-Members: $2,100
- Government/Academic/Nonprofit: $850
Learn more about the other Medical Device Submissions Workshops focused on the Investigational Device Exemption and Premarket Approval process.
IDE Submissions Workshop
February 5, 2024
FDA and industry experts will share the guidelines governing when an investigational device exemption is required. Experts will review the purpose of an IDE, share tips for making the best use of pre-submission meetings, break down the components of an IDE submission and more. This workshop will cover:
- The purpose of an IDE
- Components of a successful IDE submission
- Common errors and deficiencies in an IDE application
- Optimizing the pre-submission meeting
PMA Submissions Workshop
February 6-7, 2024
Using real-world case studies, this workshop will walk you through the practical steps of filing a PMA and offer you actionable insights on how to best navigate the PMA submission process. steps required, best practices and preparation for inspection will be covered throughout this workshop. This workshop will cover:
- Steps to develop a PMA submission strategy
- Preparation needed for an advisory panel meeting
- Tips to prepare for an inspection
- How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
- Management of approved PMAs
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