In this session, we will share insights to help you strategically prepare an eSTAR 510(k) or DeNovo submission. The presentation will cover managing text field content and limitations, organizing and naming attachments, creating advocacy in a modular format, options for creating the 510(k)Summary, and leveraging the Cover Letter and Executive Summary to your advantage. You will learn practical tactics to optimize the quality and facilitate review of your submission. We will also provide an overview of the FDA’sreview process for eSTAR submissions and strategies for how to manage submission updates in response to requests for Additional Information.
BACKGROUND:
The FDA eSTAR is currently voluntary for510(k) and De Novo submissions to CDRH andCBER, but beginning October 1, 2023, it will berequired for all new 510(k) submissions.eSTAR stands for “electronic SubmissionTemplate and Resource.” The FDA provides two eStar templates for downloading- one for IVDs and one for non-IVDs. The eSTARtemplates are interactive PDF documents tha tguide you through submission preparation by automatically generating required informatio nfields based on responses to questions. Information is provided in a combination of text fields and attachments. The content requirements in the eSTAR template are comparable to an eCopy 510(k) or De Novo submission, however, the preparation differs.
Registration Fees & Deadlines
Free
Learning Objectives
Upon completion, participants will:
- Have a working understanding of how the eSTAR templates are designed, their content requirements, and how to use the built in help features
- Be able to prepare an eSTAR 510(k) or De Novo submission
- Know how to manage submission updates during the review process.
Audience Learning Level
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.
Who Should Attend?
Regulatory Affairs professionals, management,and personnel who will prepare documentation
Lisa Pritchard
VP, Regulatory, Quality, clinical & Engineering
Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal &Associates, P.A. She works extensively onworldwide 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); qualitysystem strategies, SOP development and review, and compliance topics.
Prior to joiningDuVal & Associates, Lisa executed successful Regulatory, Quality and Compliance strategies at American Medical Systems, Medtronic,Uromedica, and EnteroMedics. She brings over 30 years of experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment ,inspection/audit preparation and conduct, quality system design, risk assessment,development of design control documentation,usability evaluations clinical trial design, and adverse event reporting. She frequently presents on topics relevant to the medica ldevice industry and is a guest lecturer with the biomedical engineering program at the University of Minnesota.
Lisa earned her Bachelor of Science, Electrical and ElectronicsEngineering, from North Dakota StateUniversity.
Kathy Herzog
Senior Regulatory, Quality & Compliance Consultant
Kathy Herzog, BSME, is a Sr. Regulatory,Quality, and Compliance Consultant at DuVal &Associates, P.A., 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 cardiac, orthopedic, neuromodulation, and urological, 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, MedicalAffairs and off-label information management, risk assessment, adverse event reporting, quality system compliance, SOP development,and compliance training.
Cancellations
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 raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
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 raps@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
For additional hands-on
support, you can also connect with RAPS support 30 min prior to the
workshop: https://www.raps.org/website/virtual-event-help
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.