Can the interference test results of qualitative diagnostic reagents be represented only by positive or negative outcomes?
Interference tests are generally conducted using a paired comparison method, comparing the results of samples containing high concentrations of interfering substances with those containing no or normal concentrations of interfering substances (control). For qualitative diagnostic reagents that can provide quantitative data (such as OD values, Ct values, etc.) or count results, it is recommended to perform a numerical difference analysis. It is not advisable to represent the results of interference tests solely by positive or negative outcomes.
Can bare-metal stents and drug-eluting stents be classified into the same registration unit?
No, they cannot. The coating is a crucial component of drug-eluting stents and significantly affects the product's safety and effectiveness. According to the "Guidance on the Division of Medical Device Registration Units" for non-active medical devices, medical devices containing drugs (active substances) and those not containing drugs (active substances) should be classified into different registration units.
The second series of issues to focus on when conducting biocompatibility evaluations for active medical devices such as patient monitors, which have many accessories in contact with the human body
Patient monitors typically include modules for ECG, body temperature, blood oxygen, non-invasive blood pressure, invasive blood pressure, respiration, EEG, anesthesia, etc., each with several accessories that come into contact with the human body, resulting in numerous accessories being declared. For easier review of the documentation, the following requirements are recommended: 1. Refer to the structure of the application form, classify by functional module, and list the names, contact parts, contact duration, nature of contact, method of biological evaluation (exemption, evaluation, testing), and corresponding evaluation documentation names and numbers for each accessory that contacts the body. 2. For biological testing, also specify the biological test items, basis for testing, test results, and test report numbers. 3. For tests conducted on representative accessories, the reasons for selecting typical models should be explained.
Can product work length that does not meet the requirements of new standards be adjusted in nominal values and tolerances based on original inspection report data to comply with new standards?
Textual modifications based solely on original inspection report data are not permissible. It is essential first to consider whether changes in product design parameters and systems are involved. If such changes are involved, samples produced after the changes should be provided for inspection. If there are no such changes, and the original production quality system control meets the new standards, re-inspection is not necessary.
Can the β2 microglobulin clearance rate test for high-flux hemodialyzers be conducted at a single blood flow rate without covering the entire range of blood flow rates?
According to clause 3.5.1.2 of the mandatory industry standard YY 0053-2016, high-flux hemodialyzers should be evaluated for β2 microglobulin clearance rate at a clinically common blood flow rate, and it is permissible to choose a single blood flow rate for this evaluation.
What issues should be considered when registering in vitro diagnostic reagents using overseas clinical trial data?
When using overseas clinical trial data for registration in China, applicants must submit the ethics opinions, clinical trial protocols, and clinical trial reports from the overseas institutions. These documents, including their format, content, and signatures, must meet the clinical trial quality management requirements of the country or region where the trials were conducted. Additionally, applicants should provide a detailed analysis of the differences in clinical trial-related factors between domestic and overseas trials, explaining the differences and the measures taken to address them. When necessary, documents related to the laws, regulations, norms, or standards on clinical trial quality management from the country or region of the overseas trial should also be submitted. Applicants must provide complete overseas clinical trial data without selection, and the overseas clinical trial report should include an analysis and conclusions of the complete clinical trial data.
What to consider for the compatibility of metal powder and printing parameters in additive manufacturing for dental restoration using laser selective melting
The compatibility between metal powder and printing parameters involves the powder's production process and the key process parameters of the printing equipment. Regarding the production process, it is necessary to submit the fundamental principles and selection criteria (such as electrode induction melting gas atomization, plasma inert gas atomization, vacuum induction melting gas atomization, plasma rotating electrode atomization), the key process parameters (such as gas pressure, flow rate and temperature, the inner diameter and spray angle of the atomization nozzle, pressure and oxygen content in the atomization tower, current and rotation speed of the rotating electrode atomization process), and related research validation materials. As for the compatibility with the key process parameters of the printing equipment, considerations should include laser power, spot diameter, scanning speed, scanning spacing, powder layer thickness, printing direction, atmospheric protection, support structures, and the temperature of the forming chamber, along with submitting related research validation materials.
What factors should be considered for the coverage of gene mutation sites in companion diagnostic reagents
For tumor companion diagnostic gene mutation detection reagents, if the gene is known to have multiple mutation sites for the same companion diagnostic purpose (such as the same companion drug), then the subsequent product design should fully consider the coverage of mutation sites in combination with the product risk-benefit analysis, and the detection range of the sites should not be arbitrarily reduced for the ease of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene test and is related to adverse drug reactions, insufficient coverage of mutation sites may increase patient risk.
Does the mandatory standard GB 11417 "Ophthalmic Optics Contact Lenses" require shelf life to be specified as an indicator in product technical requirements and tested?
According to the "Guidelines for Compiling Technical Requirements for Medical Device Products" and other relevant requirements, the shelf life of corneal contact lenses does not need to be specified as a performance indicator in the product technical requirements and tested. The shelf life study materials should be submitted during registration application in accordance with relevant standards and requirements.
One of the series of issues that should be considered when conducting biocompatibility evaluations for active medical devices with many accessories that come into contact with the human body
For active medical devices that have many accessories intended to act on the human body (including direct and indirect contact), in the potential biological risk management process, the biocompatibility evaluation work is suggested to be divided into the following three categories: 1. For those exempt from biocompatibility evaluation, it is recommended to refer to the National Food and Drug Supervision and Administration [2007] No. 345, and issue a descriptive document stating that the conditions specified in Article 4, Paragraph (1) have not occurred. 2. For those undergoing biocompatibility evaluation, it is recommended to follow the systematic approach diagram shown in GB/T 16886.1-2011 for the biological evaluation process during risk management, to select and evaluate the accessories. 3. For those undergoing biocompatibility testing, it is recommended to follow Appendix A of GB/T 16886.1-2011 to identify the data or tests that need to be supplemented for a complete risk assessment data set.