Name: Indiana Chapter In Person Event: FDA ASCA Program Roadshow
Start: 2026-08-05T16:00:00
End: 2026-08-05T18:00:00
Location: Eli Lilly and Co.

Indiana Chapter In Person Event: FDA ASCA Program Roadshow

The ASCA Program allows medical device manufacturers to use Summary Test Reports from accredited laboratories to demonstrate conformity with FDA-recognized consensus standards. It enhances confidence in testing quality and streamlines premarket review.

4pm – 6pm EDT 5 August 2026 + Add to calendar Indianapolis, IN Eli Lilly and Co.

The FDA and NAMSA will discuss the Accreditation Scheme for Conformity Assessment (ASCA) Program which enables manufacturers of FDA regulated medical devices to leverage ASCA Summary Test Reports from ASCA-accredited testing laboratories in demonstrating conformity with FDA-recognized consensus standards. The Program enhances confidence in qualified testing laboratories, mitigates risk, and streamlines premarket review of test reports.

Objectives

Program offerings will:

Provide an overview of the CDRH Division of Standards and Conformity Assessment (DSCA)
Cover the fundamentals of the ASCA Program • Discuss ASCA case studies and data demonstrating premarket benefits
Explore best practices for interacting with testing laboratories
Address data integrity in conformity assessment
Share Program updates
Invite stakeholder feedback on potential program improvements

ASCA Engagement Opportunities

The ASCA Team is available to present:
• Virtually or in-person
• Domestically and internationally (subject to location, lead time, and presenter availability)
• As independent presenters or as contribution speakers at larger events/meetings

Contact Information

Email [email protected] to learn more!

Location

Eli Lilly and Co.
893 South Delaware Street
Indianapolis, IN 46225

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.