Information and Data to Include in 510(k) Submissions for Medical Devices Labeled as Sterile Webinat - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Information and Data to Include in 510(k) Submissions for Medical Devices Labeled as Sterile" webinar to their offering.

This webinar addresses the major aspects of the FDA's recently issued draft guidance entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff - January 21, 2016."

In addition, the webinar will address all referenced guidance documents at least to the degree necessary to show why these guidance documents were referenced. Established methods of sterilization will be described, along with Strengths, Weaknesses, Opportunities, Threats (SWOT) Analysis for each of the established sterilization methods. Novel sterilization methods will be described minimally. Specific requirements for reprocessing of Single-Use Medical Devices will be addressed in detail. Pyrogen and endotoxin testing requirements along with information regarding pyrogen and endotoxin testing and Validation of the sterile barrier system (packaging) will be discussed. Specific requirements for devices that contact cerebral spinal fluid will be addressed minimally.

Objectives of the Presentation:

- Scope and purpose of the U.S. FDA's guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff - January 21, 2016"

- Strengths, Weaknesses, Opportunities, and Threats (SWOT) for Established Sterilization Methods

- Detailed requirements for information and data required in Premarket Notification (510(k)) Submission of reprocessed single use devices

- Sources of pyrogens

- Labeling requirements regarding pyrogens

- Specific validation information required and when validation data is required

- Packaging validation

Who can Benefit:

- Regulatory Affairs

- Quality Assurance

- Product Development

- Executive Management, such as CEO, Owner, President, Vice President

Areas Covered:

- Detailed review of the U.S. FDA's guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration - January 21, 2016

- The output of Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analysis for established sterilization methods

- Information requirements and data requirements in Premarket Notifications for Premarket Notification [510(k)] Submission for devices labeled as sterile, with special focus on reprocessed single use devices.

- Sources of pyrogens

- Labeling requirements regarding pyrogens

- Sterilization validation

- Packaging (sterile barrier system) validation

For more information visit http://www.researchandmarkets.com/research/l6r2nd/information_and

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Medical Devices