SESSION HIGHLIGHT FROM THE:
3rd Semi-Annual Medical Device Sterilization Conference

July 24-25, 2017 | Arlington, VA

Hyatt Centric Arlington

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REVIEWER OBSERVATIONS: FDA’S PERSPECTIVE ON DEVICE STERILIZATION

As such a heavily regulated industry, medical device manufacturers are cognizant of changing standards and regulations that impact sterility assurance and validation. As the science behind medical device product sterilization continues to develop and analysis of product sterilization becomes increasingly sophisticated, regulators increase the guidance surrounding sterility assurance and validation, requiring a continuous interpretation and integration of new requirements. The FDA will share key observations along with common challenges seen within the field. Following the presentation, the FDA will answer questions previously submitted by attendees.

• Establishing proper validation documentation for future success

• Observations and concerns from device inspections/submissions

• Avoiding common sterilization mistakes seen in the field

• Clarifying expectations for novel sterilization modalities

Presented by: Steven Turtil, Biologist, FDA and Pat Weixel, Postmarket Team Leader, FDA

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