Originally Published MDDI January
2005
Coatings
Regulatory Guidances
Phil Triolo
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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• Draft Guidance Document for Testing Biodegradable Polymer Implant Devices.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
