RAPS Workshop: Traveling to De Novo Land by eSTAR: Planning for a Successful Journey

Registration Fees & Deadlines

Learning Objectives

Upon completion of this workshop, participants will be able to:

• Identify what types of products should go through the De Novo process
• Understand how current FDA initiatives impacting the De Novo program
• Understand how to prepare a De Novo request
• Describe the advantages and disadvantages of the De Novo process to their business

Who Should Attend?

Who is the intended audience?

Regulatory Affairs Professionals:

• Regulatory Affairs Specialist
• Regulatory Affairs Manager
• Regulatory Affairs Director

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Agenda

Agenda

 **Subject to Change; FDA speakers invited

Speakers

Bryan Feldhaus, JD, LLM
President, DuVal & Associates, PA

Bryan specializes in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. His practice includes providing legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), conducting sales training, and interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters. He also provides strategic advice and advocacy regarding clinical trials and regulatory submissions including formal and informal appeals and strategic 510(k) submissions. Additionally, Bryan counsels companies on compliance matters, conducts compliance assessments, collaborates with clients to develop compliance programs, and provides compliance training to ensure clients understand and achieve their compliance goals in the context of their business objectives. Finally, Bryan advises medtech companies regarding their HIPAA and GDPR obligations as it relates to their relationship to patient data.

Lisa Pritchard, BSEEE
Vice President of Regulatory, Quality, Clinical and Engineering

Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, PA, a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics. Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, technical files, and clinical evaluation plans and reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry.

Kathy Herzog, BSME
Sr. Regulatory, Quality, and Compliance Associate, DuVal & Associates, PA

Kathy Herzog, BSME, is a Sr. Regulatory, Quality, and Compliance Consultant at DuVal & Associates, PA, a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She has worked in the medical device industry for over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and class III products in the, orthopedic, neuromodulation, urological, and wound dressing therapeutic areas. She is experienced with US marketing submissions (Q-submissions, IDEs, 510(k)s, De Novos, Breakthrough Device Designation requests, Emergency Use Authorizations, HUDs/HDES, PMAs and PMA supplements) and regulatory strategy planning for US, EU, CAN, and AU submissions, labeling development, promotional copy review, Medical Affairs and off-label information management, risk assessment, adverse event reporting, quality system compliance, SOP development, and compliance training.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions