Description
FDA has developedthis guidanceto inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices. While FDA is in the process of making more substantial updates to theNon-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systemsguidance, we are issuing this guidance update on select sections in order to notify the industry in a timely manner of our revised recommendations.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Specific product area mentioned in previous guidance.
Regulatory Context
Regulatory Activities
1PMA application for high-risk devices
Document Types
1A summary of the results of performance studies and pathogenic variants
Attributes
1Refers to device sizes with highest corrosion susceptibility or largest surface area.
Technical Details
Substances
4A buffered solution used for nickel leaching tests.
Element released from nitinol bulk during corrosion.
Inert contact surface material used in Salmonella survival study.
Metallic device material subject to corrosion testing.
Testing Methods
4Recommended if device consists of contacting dissimilar metals
Techniques to demonstrate that surfaces are equivalent in geometry and properties
Quantifying nickel ion release over time into a fluid at physiologic temperature.
Testing to assess the susceptibility of the stent to pitting.
Processes
7surface treatment process such as nitinol passivation of a peripheral stent; Surface treatment to minimize nickel toxicity
established surface finishing process
Includes crimping, tracking, and deployment through an in vitro fixture.
One of the topics updated in this guidance.
One of the topics updated in this guidance.
One of the topics updated in this guidance.
One of the topics updated in this guidance.
Identified Hazards
Hazards
3Potential toxicological risk from nickel-rich alloys.
A form of corrosion that can lead to device failure.
Release of nickel ions which may lead to toxicities.
Standards & References
External Standards
2Standard Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements.
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
Specifications
1limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
- Color Additive Petitions - Medical Devices (Status: Final)
- Shelf Life of Medical Devices (Status: Final)
- Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)