This year at the Food and Drug Administration (FDA) Regulatory Education for Industry (REdI) Conference, the Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL) Office Director, Dr. Ed Margerrison, will present "Accelerating Medical Device Innovation with Regulatory Tools" on Wednesday July 21st at 9:25 am – 10:05 am. This is part of CDRH efforts to develop tools that help innovators improve the development and assessment of emerging medical technologies.
This webinar is part of the Regulatory Education for Industry (REdI) conference, which runs from July 19 to July 23. Registration for the conference, which includes the CDRH webinar, is free.
Accelerating Medical Device Innovation with Regulatory Tools
The CDRH provides resources to facilitate medical device innovation and accelerate upstream pre-competitive innovation within the medical device industry. These resources include providing innovators with regulatory science tools to help develop and assess medical technologies that can spin out multiple products. The tools reduce the need for device developers to design ad-hoc test methods and allow them to focus their limited resources on how well their new product works, not how well it may be tested. This presentation will introduce the FDA’s Catalog of Regulatory Science Tools (https://www.fda.gov/medical-devices/science-and-research-medical-devices...) to help assess new medical devices and provide helpful resources and tips for finding and using these tools that can assist with development and assessment of emerging medical technologies.
This webinar appears on page 7 of the conference agenda: https://sbiaevents.com/files2/REdI-2021-Agenda.pdf#page=7
Additional Medical Device related topics include:
- Demystifying Medical Device Regulations
- Accelerating Medical Device Innovation with Regulatory Tools
- Q-Sub Program: What Is It and Best Practices
- The 510(k) Program - Overview and Program Updates
- The 510(k) Program - How to Determine an Effective Predicate Device
- Bioresearch Monitoring Sponsor Inspections
- Additive Manufacturing of Medical Devices