For limit of detection (LOD) and linearity studies in in vitro diagnostic reagents, how should batches and instrument types be considered?
The LOD and linearity studies for in vitro diagnostic reagents involve the establishment and validation of LOD and linearity. The samples used for establishing and validating the LOD should not be duplicated, and the samples during the study should cover all claimed types or major types. Applicants should submit registration information for all applicable instrument types, structural composition, instrument performance, reaction program settings, and a comparison of reaction systems. Representative instrument types and other types should have basic similarities in working principles, detection methods, reaction conditions, and signal processing. If there are representative instrument types within the applicable models for the product, applicants may choose to perform the establishment study on three batches of products and the validation study on one batch of products using the representative instrument type. They should also perform the validation study on three batches of products using other instrument types. Alternatively, applicants can choose to perform the establishment study on three batches of products and the validation study on one batch of products using all applicable instrument types. The analytical performance of all applicable instrument types should be essentially consistent. If any analytical performance for a particular test item differs across different instrument types, a thorough analytical performance establishment and validation study should be carried out specifically for those differences using the different instrument types. These are the general requirements for conventional in vitro diagnostic reagents. For new products, new methods, special products, or new issues that arise during performance evaluation, the specific situation should be analyzed based on the submitted documentation.
How to change contraindications in the instructions for use of a marketed medical device?
For changes in contraindications and other contents outside the items specified in the registration certificate and its annexes, the registrant can apply for changes by submitting an application to notify the change of the instructions for use.
Can the product name of medical electrical equipment include descriptive terms like "portable" or "handheld"?
The generic name of medical devices should follow the "Guiding Principles for Naming Generic Names of Medical Devices" and the naming guidelines of various product classification catalogs. The GB 9706.1 standard provides clear definitions for "handheld equipment", "mobile equipment", "portable equipment", and "transportable equipment"; however, meeting these definitions does not automatically allow the inclusion of these descriptive terms in the product name. Characteristics that are inherently common to a type of product are generally not reflected in its generic name. For example, a surgical electrode is invariably handheld, so the term "handheld" would not be added to its name. Conversely, if a product type usually comes in various designs and it's necessary to distinguish between these designs, then descriptive terms might be added. For instance, a "portable ultrasound diagnostic device" typically supports prolonged internal battery operation and is easy to hold and carry, suitable for switching between different usage scenarios like outpatient clinics, wards, operating rooms, and emergency situations. On the other hand, an ultrasound diagnostic device without any descriptive term typically refers to a cart-based mobile system, which usually does not involve changes in usage scenarios but simply moves between different locations (e.g., from one exam room to another). Therefore, descriptive terms are only considered in the product name when the product design significantly deviates from the norm and excluding such terms would cause ambiguity. For example, ultrasound surgical devices typically consist of a console (tabletop equipment), a transducer, and a handpiece. If a product integrates the power source, control components, transducer, and handpiece into a single handheld unit, it could be named "handheld ultrasound surgical device."
What items need to be tested for the shelf life validation of citric acid disinfectant?
According to GB 27949-2020 "General Requirements for Disinfectants for Medical Devices", the shelf life of a properly packaged product should be no less than 12 months. The test items should refer to the relevant clauses in the technical requirements, such as the content of each main active ingredient (the content decline after storage should be ≤10%, and the content of the main active ingredients after storage should not be lower than the lower limit specified in the product technical requirements), microbial killing indicators, appearance (including whether there are color changes, precipitation or the formation of suspensions), fill volume, pH value, corrosion resistance, etc.
If the raw materials for orthopedic or dental implant products come from two suppliers, what validations need to be conducted?
If the raw materials for orthopedic or dental implant products come from two suppliers, the applicant needs to evaluate the suppliers according to the requirements of the quality management system. In the registration application materials, the product raw material suppliers must be clearly identified. If the same raw material is sourced from two different suppliers and it is not possible to confirm that the components, content, and synthesis methods used by the two manufacturers are identical, the provided documentation must include performance verification/validation and risk assessment (including biological evaluation) for the products made from raw materials of different sources. This ensures that the products made from the raw materials from both sources have consistent performance and meet safety and effectiveness requirements.
For the blue light blocking performance of soft hydrophilic contact lenses, what special considerations should be taken into account?
In the registration application materials, the description of blue light blocking performance should avoid using promotional language such as "reducing radiation hazards." Instead, it is recommended to describe the performance indicators in accordance with the product technical requirements and research data, using terms like "blue light radiation reduction rate" and "UV light radiation reduction rate."
For energy therapy devices, how should the dose-response relationship and energy safety research data be submitted?
For medical devices that provide energy or substance therapy to patients, it is usually necessary to provide research data on the dose-response relationship and energy safety. This data should demonstrate the safety, effectiveness, and rationality of the treatment parameter settings, reflect the effects and relationships between energy and tissues, and confirm that the energy does not cause unacceptable harm to normal tissues beyond the intended target tissues. The dose-response relationship and energy safety research should include data analysis and summary from one or more non-clinical trials (bench tests, ex vivo tissue tests, in vivo animal tests), clinical trials, etc., of the product being submitted. The dose-response relationship study should evaluate the correlation between different energy output levels (covering all performance parameters and adjustment ranges of the product) and clinical application effects (including various indications or types of tissues) under all working modes and output methods of the product being submitted. These data can also serve as the basis for determining performance parameters and support materials for indications. The dose-response relationship study can be conducted through laboratory simulated tissues, ex vivo tissues, and/or in vivo animal tests, with clinical trial data and clinical experience data also being part of it. Energy safety studies should evaluate whether the energy, when acting on the target tissue under all working modes and output methods, causes unacceptable harm to the surrounding normal tissues. For the same indications and application sites, the maximum output energy level can usually be analyzed to represent other levels. Energy safety studies can be conducted through tissue and/or animal tests, analyzing the morphological and pathological changes in tissues before and after the treatment to determine if unacceptable energy damage has occurred. It's important to note that the related studies mentioned above should be conducted based on the product itself to demonstrate its energy characteristics. When conducting these studies, establishing a control group and performing equivalence analysis with already marketed products can also be considered to confirm that the dose-response relationship and energy safety are acceptable.
What Genes and Sites Can Be Included in the Detection Range of Companion Diagnostic Reagents for Tumor Gene Mutation Detection Based on High-Throughput Sequencing Technology (NGS)?
Companion diagnostic reagents for tumor gene mutation detection using high-throughput sequencing technology (NGS) in human formalin-fixed paraffin-embedded (FFPE) tissue samples typically include multiple variant genes and sites in their detection range, based on methodological characteristics and specific indications. These variant genes and sites can be divided into two categories: 1. Primary sites are genes and sites with clear companion diagnostic significance, for which clinical evidence for companion diagnostics should be provided according to relevant guidelines. 2. Secondary sites currently lack clear companion diagnostic significance, but authoritative guidelines both in China and abroad have explicitly stated their clinical significance for corresponding indications. Clinicians can apply these genes and sites based on diagnostic guidelines and the patient's specific condition to guide the patient's treatment process. Furthermore, for multi-gene tumor detection products being developed in tandem with anti-tumor drugs, their detection range includes one or more variant genes and sites involved in clinical trials of the anti-tumor drugs. If current research results demonstrate potential clinical significance for companion diagnostics, the corresponding genes and sites in the product can be included as secondary sites in the application. Once the anti-tumor drugs are launched, these can be updated to primary sites with clear companion diagnostic clinical significance through a change process. Apart from the aforementioned sites, it is not recommended to include other variant genes and sites without clear clinical significance in the detection range of the reagent kit. Additionally, for tumor gene mutation detection reagents that test cell-free DNA in plasma and other samples, the clinical significance of each gene and site for blood-based companion diagnostics and other applications should be demonstrated.
Biological Evaluation Considerations for Platelet Plasma Preparation Devices
The biological evaluation of the product should comply with the specific requirements of GB/T 16886.1 regarding relevant uses, application sites, and contact duration. The contact duration refers to the maximum cumulative time the product is in contact with the human body. Generally, the biological evaluation items should include: pyrogenicity, cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and hemocompatibility.
Do All Contact Lenses Need to Undergo Fade Testing?
Enhance-colored contact lenses (decorative colored contact lenses) are required to undergo fade testing. However, visibility-tinted contact lenses do not need to undergo fade testing. This includes soft contact lenses with visibility tinting and hard contact lenses that are colored to distinguish between left and right lenses.