A New Guideline for Intravascular Catheters Issued!
On September 7, 2021, the NMPA released the Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters. The Guideline is used to guide the registration applicant to carry out the clinical evaluation for predicate comparison of intravascular catheter products and help the evaluation agency to conduct a standardized review on the clinical evaluation of such products.
Scope of Application
In this guideline, intravascular catheter refers to single-lumen or multi-lumen tubular device that can be partially or completely inserted or implanted into venous or arterial system and used to establish vascular access to external liquid or other substances. It includes:
- Central venous catheter (CVC)
- Peripherally inserted central catheter (PICC)
- Totally implantable access port (TIAP) with catheter tip or tip entering central vein
- Peripheral venous catheter (PIV, or midline catheter)
Notes: Catheters with independent diagnosis or treatment function, such as vascular balloon dilatation catheters are excluded.
Basic Principles for Pedicate Comparison of Intravascular Catheters
(1) When making predicate comparison, the selected predicate shall be the product which has been released to market and has basically the same intended uses and similar technical characteristics. It should be compared from three aspects:
- Intended use
- Technical characteristics
- Biological characteristics.
(2) It is suggested to firstly consider selecting similar products as the predicates. If it is necessary to select different types of products or multiple products as the predicates, the reason shall be fully explained.
(3) Given the predicate comparison requires a comprehensive evaluation, it is recommended to compare all items when comparing with each predicate except for the cases of completely independent components.
As the new guideline is issued, relevant manufacturers of intravascular catheters shall pay special attention to whether their products meet the above principles when applying for registration. Brady has seasoned staff in registration and can help manufacturers to make an appropriate strategy on the option of clinical evaluation pathway. If you are not sure whether your product is suitable for CER pathway, please feel free to contact us (info@inspirativemed.com) for more information.
