Combination Product Industry News & Guidance
Sharing device-related information and wisdom
that will help you succeed
The Experiential Learning Program (ELP) is a collaborative learning experience between CDRH Staff and industry participants in the following businesses:
- Medical devices
- Emerging technologies
- Lab practices
- QMS
- Patient needs and their Impact on device development
Through the ELP you will educate FDA Staff on the design and manufacturing of your drug delivery devices and development challenges thru open discussion and Q&A. Industry participants host up to 15 FDA staff members for a 1 to 2-day (virtual or on-site) program. It is a unique opportunity to help familiarize FDA staff about your product and to have your voice heard about development challenges you experience.
Suttons Creek has several former FDA reviewers who have participated in this program in the past and know how valuable it can be for reviewers.
The FDA has listed Combination Products (Drug Delivery Systems and Infusion Pumps) as areas of interest for 2024. We know these are challenging regulatory environments, so this is your chance to have open two-way conversation and education on these topics.
Specific areas of current interest include:
- Performance testing
- Drug filling processes
- Stability testing
- Supplier controls and managmenet
- Risk analysis
For more information, click here to visit the FDA’s information page.
If you have questions about ELP’s Spring 2024 cycle, please contact the ELP Program Manager at [email protected].
And, you can always reach out to talk to us at Suttons Creek for an insider’s perspective of the process.