Join the NJ and Philadelphia chapters as we host FDA and Intertek speakers discussing FDA’s Accreditation Scheme for Conformity Assessment (ASCA) and how it streamlines premarket review by elevating the quality and consistency of testing laboratories, enabling reviewers to assess complex areas like biocompatibility and EMC in minutes rather than hours.
Every medical device that reaches a patient first passes through a gauntlet of testing — mechanical, biocompatibility, electrical safety, performance testing and then navigate FDA's premarket review. Just testing a medical device can take months and generate several hundreds of pages of documentation. But what if the review of those test reports could take less than an hour, enhanced by FDA's confidence in the testing, and minimize deficiencies?
This presentation overviews and provides updates on FDA's Accreditation Scheme for Conformity Assessment (ASCA) Program — a premarket tool that puts voluntary consensus standards to work by ensuring testing laboratories are held to a higher standard of quality and accountability. Learn how ASCA streamlines review of challenging technical areas like biocompatibility and electromagnetic compatibility, precipitates fewer deficiencies, and protects the integrity of test data — all while building a global network of trusted labs. Real premarket submission case studies demonstrate the benefits of ASCA Summary Test Reports: reviews that once took a multitude of hours completed in minutes, submissions once stalled for months resolved in weeks. Whether you're a manufacturer, a test lab, or someone curious about how FDA keeps pace with an ever-evolving device landscape, this session offers a clear-eyed look at a program reshaping conformity assessment in premarket review.
Location
Temple University Learning Center at Ambler Campus
580 Meetinghouse Road
Ambler, PA 19002
Parking is free, please register in advance: https://ambler.temple.edu/visitor
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 [email protected]. 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 [email protected] 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 [email protected].
Speakers
