Assurance Case Reports — Infusion Pumps
The FDA has announced a new initiative to address safety problems associated with external infusion pumps. As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps. FDA’s new guidance recommends that infusion pump manufacturers begin to provide additional design and engineering information during premarket review of the devices.
The FDA is recommending that manufacturers demonstrate substantial equivalence through the use of assurance case reports. Assurance case reports have not been previously used in medical device submissions.
To address the manufacturer's education needs to comply with FDA requirements, AAMI offers this webinar on Assurance Case Reports – Infusion Pumps.
The webinar cd content includes a discussion by the FDA explaining what is required for approval when an assurance case is submitted. This is followed by a brief summary of assurance case technology. The bulk of the webinar content is a detailed presentation of the technology of assurance cases and how they are developed. This material includes a detailed but strictly hypothetical example from the medical device domain.
PROGRAM-AT-A-GLANCE
- FDA Perspective
- Brief Background on Assurance Cases
- Technical Issues
- Summary and Wrap-up
SPEAKERS
- John C. Knight, PhD, Professor of Computer Science, University of Virginia
- Richard C. Chapman, BA, MS, Acting Branch Chief, General Hospital Devices Branch, Office of Device Evaluation, Center for Devices & Radiological Health, US Food & Drug Administration (FDA)
WHO SHOULD PURCHASE
The webinar is designed for infusion pump manufacturers.
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD.
- $295 for webinar registrants
- $395 for non-registrants
WAYS TO ORDER
1. Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card
2. Fax – Select and download the order form and fax to 240-396-5781
3. Mail – Select and download the order form and mail with payment to:
Assurance Case: Infusion Pumps CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.