Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices and, as such, play a key role in promoting safety and public health. When manufacturers rely upon FDA-recognized standards, submission documentation is less burdensome and more streamlined.
This session will demonstrate the value of standards, explain how to cite them to maximize efficiencies, including in eSTAR, and introduce participants to the FDA’s latest program to enhance standards’ use: the Accreditation Scheme for Conformity Assessment, or ASCA. This discussion will also provide updates and insights to help regulatory professionals understand the FDA eSTAR program and how to cite standards using the eSTAR templates.
Registration Fees & Deadlines
Member $20 | Nonmember $40 | Students: Free
Speakers
Gail Rodriguez, Ph.D.
Senior Policy Advisor, CDRH, OSPT1
US Food and Drug Administration
Patrick Atell, Ph.D.
Assistant Director, Tools & Templates Team, CDRH, RP/DRP4,
US Food and Drug Administration
Patrick Axtell, Ph.D., is a biomedical engineer and software developer at the FDA. He graduated from The College of William and Mary with a bachelor’s degree in Biology, and he received his doctorate in Biomedical Engineering with a specialization in Neural Engineering from The University of Illinois in Chicago in 2007. Patrick was a reviewer for restorative and neurological devices for seven years and is now the assistant director for the tools and templates team for CDRH. Patrick developed the smart template, which guides reviewers through the evaluation of medical devices, and eSTAR, which guides applicants through the process of preparing 510(k)s and other submission types.
Chapter Event Sponsor
Location
Boston Scientific Corporation
4100 Hamline Ave N, Bldg 3
Visitors Center
St Paul, MN
Campus Map
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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org