This two day workshop provides attendees the unique opportunity to better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the workshop you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Who should attend? Past attendees had titles including:
- Manager of Regulatory Affairs
- Director of Quality and Regulatory Affairs
- Regulatory Affairs Specialist/Associate
- Vice President of Regulatory & Clinical Affairs
- Regulatory Technical Specialist
- Quality Manager
- Director of Global
- ...and many more!
Who else is going? Connect with regulatory professionals from industry-leading companies that include:
- Boston Scientific
- Cardinal Health
- Edwards Lifesciences
- Johnson & Johnson
Agenda topics will include:
- FDA’s updates to the 510(k) process
- Different types of 510(k)s
- Considerations for determining a product's regulatory route to market
- Factors to consider when planning and assembling a 510(k) submission
- Tips and hints on interacting with FDA during the 510(k) review process
- Deciding when to submit a new 510(k) for a device modification
- And more
- Marjorie Shulman, Director, Premarket Notification Program, ODE/CDRH/FDA
- Tony Blank, Barton & Blank LLC
- Andy Van Haute, Sidley Austin
- Frank Pokrop, Director, Regulatory Affairs, BD
Marjorie Shulman has been with the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA) since 1984. She is currently on the Premarket Notification Staff (510(k) Staff) in the Office of Device Evaluation (ODE) and is also the Reclassification/Classification Coordinator for CDRH. Ms. Shulman is the Project Officer for the ODE and the Office of Communication, Education and Radiation Programs Document Control Centers and CDRH's Mailroom. Ms. Shulman has been on numerous policy setting groups with in the FDA with the most 2 recent being the enactment of the Medical Device User Fee Modernization Act. Ms. Shulman received her undergraduate degree from the University of Maryland and received her MBA from Hood College in May 1997.
Anthony (Tony) Blank is Cofounder and Senior Advisor at Barton & Blank LLC, a specialized regulatory consulting firm for the medical device and combination products industry. Mr. Blank has served in a variety of roles in the medical products industry - including Clinical and Regulatory - for the past 25 years. Most recently, Mr. Blank spent 12 years at Boston Scientific Corporation in both Corporate and Business regulatory leadership roles, including Vice President of Regulatory Affairs for the CRV businesses (Cardiology, Rhythm and Vascular). Under his leadership, the Boston Scientific obtained numerous regulatory approvals for medical devices and combination products. Among these are world-wide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resychronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Mr. Blank has likewise been an active representative for Boston Scientific, 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 cochaired). He is very involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.
Andrew Van Haute, Esq. is an associate Sidley’s Washington, D.C. office who counsels life sciences companies on a wide range of FDA and healthcare regulatory issues. As part of Sidley’s Healthcare group, Andy advises pharmaceutical and medical device manufacturers and other healthcare entities on compliance with the Federal Anti-Kickback Statute and other fraud and abuse laws, healthcare compliance programs, federal healthcare program reimbursement and Sunshine Act compliance. And as a member of Sidley’s Food, Drug, and Medical Device Regulatory group, Andy provides advice to FDA-regulated companies on clinical trials registration, product approvals and clearances, advertising and promotional claims and adverse event reporting obligations. Andy has spoken at a variety of national and local conferences to physician groups and others on issues of importance to the life sciences industry. He is a frequent guest lecturer at George Washington University’s Healthcare Corporate Compliance Certificate Program and has also been a guest lecturer at Northwestern University’s multi-disciplinary NUVention program. Prior to joining Sidley, Andy had a particular focus on the medical device industry, having served as associate general counsel for AdvaMed, the leading global trade association for medical technology companies. In this position Andy developed legal and compliance policy positions on behalf of the industry and worked closely with industry leaders to advance the Association’s priorities. Andy played a key role in the 2008 development of AdvaMed’s revised Code of Ethics on Interactions with Health Care Professionals, as well as in the development subsequent best practices guidance for companies on implementing the Code. He also worked closely in the areas of device promotion, Physician-Owned Distributors (PODs), Physician Payment Sunshine, OIG exclusion policy and the creation and harmonization of ethical standards for industry in markets around the world. While at AdvaMed, Andy also advised the Association and its staff on a broad scope of internal legal issues.
Frank Pokrop has worked in the drug and medical device industries for more than 20 years and has obtained these certifications: CSQE, CISA, CPGP and RAC. His background includes worldwide submissions, recall management, product launches, vigilance reporting, and manufacturing operations for drugs and devices. He has been a member of MD&DI's Editorial Advisory Board since 2006, he volunteers at UCSD on the “B” IRB, he has been an officer in the San Diego Regulatory Affairs Network (SDRAN) since 2010.
AdvaMed Member Registration: $1,595
Accel Member Registration: $695
Government and Non-Profit Registration: $695
Non-Member Registration: $2,095
Cancellation and Refund Policy
All cancellations must be received via email to firstname.lastname@example.org. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at email@example.com with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.