- June 23, 2021
- 10:30 AM - 5:00 PM ET
- Organized By:
Virtual Event: FDA Medical Device Virtual Conference 2021
Date: June 23, 2021
Time: 10:30 AM - 5:00 PM ET
This event is FREE to attend, but space is limited!
This one-day virtual conference, hosted by the Office of Medical Device and Radiological Health Operations, offers representatives of registered firms with the Food and Drug Administration (FDA) to learn about current FDA operations.
Attendees will hear from subject matter experts on a variety of topics including:
- Remote Regulatory Assessment;
- ORA/CDRH resources available to industry;
- The UDI Program;
- Post-Market Risk Management; and
- Effectively communicating with the FDA.
Visit: https://www.fda.gov/about-fda/ora-program-areas/medical-device-radiological-health for additional information on ORA’s Medical Device & Radiological Health program area.
For questions or any additional information, please send an email to: ORAMedDeviceConference@fda.hhs.gov
|Virtual Conference Agenda with Summaries||pdf (167.31 KB)|
|Presentation 1. Opening Presentation - Rosanna Goodrich||pdf (287.69 KB)|
|Presentation 2. ORA-CDRH Medical Device Resources Available for Industry - Corson, Sullivan, and Bediakoh||pdf (875.28 KB)|
|Presentation 3. AccessGUDID Are You There Yet & Why You Should Be - understanding UDI and the latest deadlines - CDR Stephen Smith||pdf (1.79 MB)|
|Presentation 4. FDA Review of Class I and II Recalls - Meredith Andress||pdf (784.00 KB)|
|Presentation 5. Effective Communication Before and During an Inspection - Debara Reese||pdf (437.31 KB)|
|Presentation 6. Effective Communication After an Inspection - Karen Archdeacon||pdf (232.98 KB)|
|Presentation 7. Risk & TPLC - Katelyn Staub-Zamperini||pdf (870.25 KB)|
|Presentation 8. Uncovering and Maximizing the Value of FDA Inspections - LT Colin Tack||pdf (1.19 MB)|
|Presentation 9. Lets Talk About RRAs||pdf (414.09 KB)|
|Presentation 10. SP Ending Presentation- Rosanna Goodrich||pdf (68.03 KB)|