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CDRH 2015 Priorities to be Addressed at OMTEC

FDA’s Center for Device and Radiological Health (CDRH) issued a list of guidance documents it intends to publish in 2015, as well as other changes to its priorities, such as a retrospective review of previously-issued final guidance documents and a new guidance document database.

Pertinent topics for orthopaedic device companies, based on CDRH’s 2015 priorities, will be addressed by industry experts and CDRH directors at OMTEC 2015, such as FDA Update: What's New in Orthopaedic Devices. Others include the following.

Final Guidance Topics

     Applying Human Factors & Usability Engineering to Optimize Medical Device Design
        • OMTEC Session

     Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
        • OMTEC Session: Improve Your Device Submission Process

     Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

     Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification

     Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing

Draft Guidance Topics

     UDI FAQs
        • OMTEC Sessions: UDI: Lessons in Implementation
        • UDI: How Do I Make This Data Work for Me?

     Medical Device Accessories

     Medical Device Decision Support Software

     Benefit/Risk Factors to Consider When Reviewing IDE Submissions

     UDI Direct Marking

     Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements

     Adaptive Design for Medical Device Clinical Studies

Stay informed on these and other relevant topics through OMTEC’s education sessions.  For all OMTEC 2015 Education, click here.