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Regulatory Guidances

Originally Published MDDI January 2005

Originally Published MDDI January 2005


Regulatory Guidances

Phil Triolo

For many devices regulated by CDRH, guidance documents recommend the information to be provided in a 510(k) application for a device and its coating. These include:

• Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters. This guidance specifically addresses the requirements for antimicrobial and lubricious coatings applied to urinary catheters.
• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters. This guidance addresses the requirements for antimicrobial and antithrombotic-augmented intravascular catheters.
• Draft Guidance Document for Testing Biodegradable Polymer Implant Devices. Although this document is written for orthopedic implants, primarily degradable screws and fixation devices, much of it is applicable to evaluating any biodegradable polymer implant or coating.
• Guidance for Industry on the Testing of Metallic
Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. This guidance identifies specific requirements for the physical and mechanical properties of thermal porous coatings on orthopedic implants to demonstrate substantial equivalence to existing devices, thereby removing the necessity to conduct postmarket studies.

Copyright ©2005 Medical Device & Diagnostic Industry

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