Description
This document supersedes the guidance “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” dated January 13, 2005.
Scope & Applicability
Product Classes
8Specific product area mentioned in previous guidance.
Modeling requirements for non-bifurcated vessels; measurement of particulates generated during simulated delivery and deployment
recommendations for verifying unconstrained expanded diameter
Specific category of metal expandable biliary stents.
A balloon expandable stent is expanded by a balloon catheter.; Testing requirements for balloon expandable stents including RBP and fatigue; requires a compliance chart for pre-mounted versions
A self-expanding stent's diameter increases from its pre-deployed size to its post-deployed size.; Specific stent type requiring foreshortening data
Generally 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.
Guidance for non-clinical engineering tests and labeling
Stakeholders
3Entity responsible for submitting applications under section 524B
An independent third-party body that can categorize adverse events.
Independent board to oversee neonatal trials
Regulatory Context
Attributes
10Mechanical property of the stent providing radial support.; pressure at which stent experiences irrecoverable deformation
average diameter following deployment at various pressures
Rated Burst Pressure attribute for labeling
device description attribute for labeling
Pressure at which 99.9% of balloons can survive with 95% confidence; Pressure testing for catheters intended for ISR
Maximum diameter between the proximal end of the mounted stent and distal tip
expanded to the maximum labeled diameter for self-expanding stents
perform testing on sizes that represent four corners of the stent design
Reported in a table to show calculation method
Includes manufacturing, loading, and expansion steps
Identified Hazards
Hazards
10Assessment of particles generated by the device during use.
pyrogenic responses to chemical leachants
dislodgment of the stent prior to deployment
Risk from excessively slow inflation or deflation of a balloon
Risk during compatibility testing with PTCA catheters
MRI of patients with stents poses potential hazards including heating
Risk associated with rusting components in guidewires.
Failure mode evaluated during durability testing
Failure mode evaluated during durability testing
corrosion concern for nitinol devices; may lead to higher rates of nickel ion release
Related CFR Sections (2)
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (Status: Final)
- Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry (Status: Final)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff (Status: Final)