Events

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

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 Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

  1. Overview
  2. Agendas
  3. Speakers
  4. Location & Housing
  5. Pricing

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

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)! After years of hosting this event virtually, 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

510(k) Submissions Workshop

*Schedule reflects Eastern Time 
February 5, 2024
 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 amBreak
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 
February 6, 2024
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 amRegulatory 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 pmFDA 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 pmBreak  
2:15 – 4:15 pmApplied 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 pmAdjournment 

Investigational Device Exemption (IDE) Submissions Workshop

*Schedule reflects Eastern Time 
February 7, 2024
8:30 – 9:00 am Registration Check-In and Continental Breakfast 
9:00 – 9:05 am Welcome and Introductions 
9:05 – 10:00 am What Is an IDE? 
Anne Talley, Chemical Engineer, FDA     
– Regulatory Context 
– When is an IDE needed? 
– Roles of sponsors, investigators and IRBs 
– The IDE Application and Helpful Tips 
10:00 – 11:00 am Developing an IDE Strategy 
Tony Blank, Senior Director of Regulatory Affairs, AtriCure  
– What to consider and when 
– Preclinical testing before human studies 
– Making the best use of pre-submission meetings 
– Using foreign data in a US submission 
– Characteristics of a successful IDE submission 
11:00 – 11:15 am Break 
11:15 am – 12:30 pm Preparing the Technical & Functional Aspects of an IDE 
Kristin Zielinski Duggan, Partner, Global Regulatory, Hogan Lovells 
– Monitoring 
– Consenting of patients 
– Enrollment requirements 
– Adverse event reporting 
– Sponsor records and reports 
– Investigator records and reports 
– Protocol deviations 
12:30 – 1:30 pm Networking Lunch 
1:30 – 2:15 pm Regulatory Compliance During Study Conduct  
Tony Blank, Senior Director of Regulatory Affairs, AtriCure  
– Clinical study reports (interim and final) 
– Dissemination to the medical community and to regulators 
– Incorporation into pre-market submissions 
– Assessment of impact to product labeling 
– Requirements for registering trials on CT.gov    
2:15 – 3:00 pm Reporting Results   
Kristin Zielinski Duggan, Partner, Global Regulatory, Hogan Lovells  

– Clinical study reports (interim and final) 
– Dissemination to the medical community and to regulators 
– Incorporation into pre-market submissions 
– Assessment of impact to product labeling 
– Requirements for registering trials on CT.gov   
3:00 – 3:15 pm  Break 
3:15 – 4:00 pmOptimizing the Pre-Submission Meeting 
Tony Blank, Senior Director of Regulatory Affairs, AtriCure  
– What to consider and when 
– Preclinical testing before human studies 
– Making the best use of pre-submission meetings 
– Using foreign data in a US submission 
– Characteristics of a successful IDE submission
4:00 – 4:45 pmBIMO Inspections 
Amrin Chowdhury, Health Scientist, FDA    
– The purpose of a BIMO inspection 
– When and how a BIMO inspection occurs 
– Preventing findings and responding to findings 
– Typical and atypical observations – cautionary tales from the field 
4:45 – 5:15 pm Speaker Q&A 
5:15 pm Adjournment 

Premarket Approval (PMA) Submissions Workshop 

*Schedule reflects Eastern Time 
February 8, 2024
8:30 – 9:00 am Registration Check-In and Continental Breakfast 
9:00 – 9:05 am Welcome and Introductions 
9:05 – 10:00 am Beginning at the Beginning 
Quynh Hoang, Senior Regulatory Consultant, FDA and Life Science
Practice, King & Spalding  
– When is a De Novo or PMA required 
– PMA:  what to expect 
-What are the standards of evidence 
-What are the standards of review 
-Will submission go to panel 
-How much will it cost 
-How long will it take to get approval 
10:00 – 10:45 am Development of a PMA Submission Strategy 
Susannah Gilbert, FDA 
– Product definition 
– Development of testing requirements and strategy 
– Desired patient population 
– Desired claims 
– Early interactions with FDA 
– Planning for product iterations 
10:45 –
11:00 am 
Break   
11:00 – 12:00 pm Mechanics of PMA Quality System Submission
Development and Review   
Jhumur Banik, PMA Policy Analyst; PMA, HDE, Q-Submission and Device Tracking Lifecyle (PHQ) Team, Division of Submission Support (DRP1), Office of Regulatory Programs (ORP), CDRH, FDA   
– Defining data requirements  
– Required elements 
– Presentation of information with clarity 
– Expectations during review 
– Best practices 
– Manufacturing & Quality Systems 
– Case for Quality 
 
12:00 – 1:00 pm 
Networking Lunch 
1:00 – 2:00 pm During Submission Review 
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific 
– Interactions with the FDA 
– When/How to expect questions 
– Types of letters 
– Timelines 
– Day 100 meetings 
– Labeling review 
2:00 – 3:00 pm Conditions of Approval Studies 
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific 
– Criteria and objectives 
– Early collaboration with FDA 
– Reaching agreement 
– Reporting outcomes 
– 522 Studies 
3:00 – 3:15 pmBreak 
3:15 – 4:15 pm Preparation for Advisory Panels 
Jessica Ringel, Partner, King & Spalding 
– When? 
– Who are the panel members? 
– Why have a panel meeting? 
– Preparation for a panel meeting 
– What to expect before, during, and after 
– Best practices 
4:15 – 5:15 pm Networking Reception 
February 9, 2024
8:30 – 9:00 am Continental Breakfast 
9:00 – 10:00 am Inspection Activity 
Jacob Dyer, Senior Regulatory Officer, FDA  
– Pre-approval inspections 
– How to prepare for an inspection 
10:00 – 11:00 am Dealing with the Unexpected 
Tony Blank, Senior Director of Regulatory Affair, AtriCure  
– Clinical outcomes 
– Animal test results 
– Adverse panel recommendation 
11:00 – 11:15 am Break   
11:15 am – 12:15 pm The Care and Feeding of Approved PMAs 
Monica Montanez, Principal Strategy Consultant, NAMSA 
– Periodic (“Annual”) Reports 
– Supplemental Submissions  
– 30-day notices 
12:15 – 1:15 pm Networking Lunch 
1:15 – 2:00 pm CDRH Ombudsman’s Office 
Ken Skodacek, Center for Devices and Radiological Health, Deputy Ombudsman, FDA   
– Roles & Responsibilities 
– The Appeals Process 
2:00 – 2:15 pm Break 
2:15 – 4:15 pmApplied Learning and Breakout Discussions 
Tony Blank, Senior Director of Regulatory Affair, AtriCure  
– PMA Recap 
– Facilitated Breakout Group Deep Dive 
-Hypothetical Case Studies  
-Key Takeaways  
-Regroup for Final Program Q&A 
4:15 pmAdjournment  

Meet the 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. Previously, she was a Lead Reviewer/Biomedical Engineer with Office of Health Technology 2 where she conducted numerous lead and consulting reviews while also contributing to the standards and guidance development efforts in the cardiovascular devices space. Before joining FDA, she worked in Regulatory Affairs for medical device manufacturers. She received her BS and MS degrees in Biomedical Engineering from Rensselaer Polytechnic Institute (RPI) in NY.  

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.  

Jennifer has nearly 30 years’ Regulatory experience.  She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device.  She also works with integration projects, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program.    

Jennifer has supported global strategies for some of Boston Scientific’s mechanical circulatory support devices, transcatheter aortic valves, left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons/guidewires, and vascular surgery grafts/fabrics.  Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics). 

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.

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.  

Amrin received her MS in Health Science from George Washington University. 

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. 

He obtained his bachelor’s degree in biomedical engineering from the University of Tennessee, his master’s degree in the same field from the New Jersey Institute of Technology, and his MBA from Johns Hopkins Carey Business School.  

Jemin maintains a Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS). RAC is the only credential for regulatory professionals in the health care product sector. 

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.   

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. 

Prior to her work at FDA, she performed research with robots intended for use in stroke rehabilitation at the MedStar National Rehabilitation Hospital. She obtained her Master’s degree in biomedical engineering from The Catholic University of America, Washington, D.C. 

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.

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. 

Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years – including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels – Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date. 

Kristin also assists companies with compliance challenges, including 483 and Warning Letter responses, adverse events reporting, recalls, Department of Justice (DOJ) investigations, and product liability litigation, as well as with due diligence for investments and acquisitions. 

Kristin’s practice covers products in many therapeutic areas, including software products, cardiovascular products, orthopedic and gynecologic implants, plastic and reconstructive surgery devices, radiology devices, gastroenterology devices, wound care products, dental implants, endoscopes and minimally-invasive surgical solutions, and in vitro diagnostics. 

Kristin previously served as Vice President for Strategic Consulting at a Washington, D.C.-based scientific consulting firm. Throughout her career, she has published and presented on various FDA regulatory issues. She is also an adjunct professor teaching an experiential seminar on FDA Regulation of Medical Products (Medical Devices, Drugs, and Biologics), which is part of the Executive Master of Science in Health Systems Administration (EMHSA) program at Georgetown University’s School of Nursing and Health Studies. 

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. 

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. 

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. 

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. She is the in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica also holds a Master’s of Science in Regulatory Science from the School of Pharmacy University of Southern California.  

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.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.  She further assists life sciences firms with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program.    

Jessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.  She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance. 

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.  He represented the CDRH Innovation Team as a founding member of the Center’s Payor Communications Task Force, which provides opportunities to improve patient access to innovative medical devices important to public health by engaging manufacturers, payors, and healthcare technology assessment organizations.  He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement. 

Prior to joining FDA/CDRH in 2008, he worked for ~20 years in the medical device industry, serving in engineering and leadership roles with a focus on managing teams that served as the clinical and technical interface between the company and healthcare providers.  He has extensive experience designing and testing devices, conducting animal studies, conducting IDE and international clinical trials, preparing regulatory submissions, negotiating with FDA, and launching products for marketing and sales in U.S. and international markets. 

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.  

After hosting this event virtually for the past few years we’re excited to include a hybrid option for the 2024 Workshops. Attendees can register to join us in our AdvaMed offices located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

Housing

You can secure housing within AdvaMed’s room block at the JW Marriott hotel on 1331 Pennsylvania Avenue N.W. Washington, DC 20004. Click here to reserve your room before the housing block closes on January 19, 2024.

510(k) and De Novo Pricing

AdvaMed Member In Person: $1650

AdvaMed Member Virtual: $1350

AdvaMed Accel Member In Person: $950

AdvaMed Accel Member Virtual: $650

Non-Members In Person: $2150

Non-Members Virtual: $1850

Government/Academic/Nonprofit In Person: $950

Government/Academic/Nonprofit Virtual: $650

Investigational Device Exemption (IDE) Pricing

AdvaMed Member In Person: $975

AdvaMed Member Virtual: $1350

AdvaMed Accel Member In Person: $950

AdvaMed Accel Member Virtual: $500

Non-Members In Person: $1275

Non-Members Virtual: $975

Government/Academic/Nonprofit In Person: $775

Government/Academic/Nonprofit Virtual: $500

Premarket Approval (PMA) Pricing

AdvaMed Member In Person: $1650

AdvaMed Member Virtual: $1350

AdvaMed Accel Member In Person: $950

AdvaMed Accel Member Virtual: $650

Non-Members In Person: $2150

Non-Members Virtual: $1850

Government/Academic/Nonprofit In Person: $950

Government/Academic/Nonprofit Virtual: $650

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