Regional Analysis
North America region held dominant position in the global Huber needles market in 2019, accounting for 42.1% share in terms of value, followed by Europe.
Figure 1. Global Huber Needles Market Share (%), by Region, 2019
Geographies Covered:
- The U.S. FDA authorizes the use of Huber needles for long term medication infusion and blood withdrawal
- Huber needles are type of safety vascular access needles that fall under class II with special controls. However, companies need a premarket approval before commercializing the device.
- FDA mandates performance tests for stiffness, bending breakage, corrosive resistance and elasticity of Huber needles
- Huber needle manufacturers are expected to submit performance tests in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of Huber needles. These devices require a premarket approval (PMA) application before marketing and commercialization.
Geographies Covered:
- According to FDA, the basic structure of Huber needle contains needle, needle cap and needle hub. These needles are either straight type available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’ or bent 90 degree angle available in gauges 19, 20, and 22, and length 1’’ to 1-1/2’’
- FDA has set few standard guideline in order to meet the safety requirement. These devices falls under the category of class II devices (Special Controls) or Class III (PMA).
U.S.: 
U.K. : 
India : 
