Table 2.

Common concerns, with applicable resources and references, raised by the FDA during review of premarket submissions for uncoated catheters

CategoryMain Issues of FDA Concern Missing or Insufficient in SubmissionsReference for Deficiencies
Device descriptionDescription of catheter accessories not clearFDA 1997 GD: Sections D-1 and D-4d (96)
Inconsistency in catheter materials
Lack of colorant information provided
Inadequate diagrams of proposed or predicate devices
Predicate device comparisonMaterials (including colorants) different from predicate cathetersFDA 1997 GD: Sections III and E-3 (96)
FDA 2016 GD: Section 4 (97)
LabelingIncomplete or missing lists of warnings and complicationsFDA 1997 GD: Sections B-1 and B-3-k (96)
Missing list of contraindicationsFDA 2016 GD: Section IV.F (97)
Incomplete cleaning/chemical compatibility
Incomplete instructions on proper positioning
Incomplete instructions on ways to reduce catheter-related bloodstream infections
Sterilization/shelf lifeLack of real-time aging validation or concern about design changes on agingFDA 1997 GD: Sections F-5-b Attachment 2 (96)
Internal standards not in agreement with industry standardFDA 2016 GD: Section IV.E (97)
Lack of comparison of packaging materials and configuration for proposed and predicate devicesPredicate reviews and requirements
Inconsistent shelf life with past version of deviceIndustry standards
BiocompatibilityIncomplete test methods and reportsFDA 1997 GD: Section F-1 (96)
Extraction procedure inadequately describedOther guidance and International Organization for Standardization standards cited
Inadequate systemic toxicity testingFDA 2016 GD: Section IV.C (97)
Inadequate thrombosis study results
Inadequate toxicology risk assessment
Materials incompletely characterized
Performance testingPerformance testing did not support reversibilityFDA 2016 GD: Section IV.G.2 (97)
Incomplete clamp test methods and results
Incomplete mechanical hemolysis test results
Air/leak testing result inadequate
Flow rate testing: proper solvent
Inadequate tensile test results with reduced performance after accelerated aging
Inadequate pressure versus flow-testing methodology
Lack of acceptance criteria for recirculation testing
Inadequate chemical tolerance or exposure test results
Differences in MRI compatibility between proposed and predicate devices
  • FDA, US Food and Drug Administration; GD, Guidance Document; MRI, magnetic resonance imaging.