510K Evaluation

2024 Submissions Workshop Evaluation

April 22 / Morning Sessions

510(k) - Charles Chiang *

Update - Courtney Lias *

De Novo - Joseph Cleveland *

STeP - Jade Noble *

Pre-Submissions - Nam To *

April 22 / Afternoon Sessions

Diagnostic Data... - Sara Brenner/Keith Campbell *

Predetermined Change... - Brittany Schuck *

Consensus Standards - Konstantinos Makrodimitris *

Medical Device Cybersecurity / James Graves *

April 23 / Morning Sessions

DICE - Eva Ellsworth *

Study Design - Marina Kondratovich *

eMDR - Michelle Rios / Fariba Maramkhah *

CLIA - Tamara Pinkney *

Bioresearch Monitoring - Adaliz Santaliz-Cruz *

April 23 / Afternoon Sessions

eSTAR - Lili Duan *

CDRH Portal - Nels Anderson *

Registration and Listing - Lisa King *

Quality System Regulations - Eric Horowitz *

Investigational Device...- Brittany Aguila *

Please rate the overall event on the following using the same scale of 1 being poor to 5 being excellent:

What speakers/topics would you like to suggest for future programs? *

Please tell us your years of regulatory experience *

Format & Organization *

Time Frames *

Overall relevance / value *

What suggestions for improvements or additions to the program would you offer? *

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