Webinar:  Sterility Information in Premarket Notification (510k) Submissions for Medical Device
Channel: Invent Healthcare
Date: 2018-06-26

Webinar:  Sterility Information in Premarket Notification (510k) Submissions for Medical Device
Slide: https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM485832.pdf

Summary: The focus of today’s Webinar is to review the document and help manufacturers and other stakeholders understand the information provided in this final guidance. Your presenter is Steven Turtil, a biologist from the Office of Device Evaluation. This guidance seeks to ensure that manufacturers incorporate adequate sterilization methods for 510(k) devices labeled as sterile and provide appropriate documentation and information to the FDA for premarket review for established and novel sterilization processes.