How should artificial vertebral body product registration units be divided?
Artificial vertebral body products are used for vertebral replacement to provide immediate stability. Products with different materials for the parts that perform the main functions (e.g., the material replacing the vertebra, including the material grade) should be divided into different registration units. According to the commonly used materials for artificial vertebral body products, artificial vertebral bodies made of materials like polyetheretherketone (PEEK), TC20 titanium alloy, and TC4 titanium alloy are divided into different registration units. If the materials of the product components are different, but the products are used as a whole assembly or combination, they can be declared under the same registration unit. Standardized artificial vertebral bodies and customized artificial vertebral bodies belong to different registration units.
Dental implant products registration units should be divided
Dental implants are medical devices implanted in the jawbone through surgical procedures to support denture restorations. Implants with different body materials should be classified into different registration units; implants with different surface treatment methods should be classified into different registration units; implants with different compositional structures should be classified into different registration units; implants with different forming processes should be classified into different registration units. Implant systems that must be used together inseparably to achieve the intended purpose can be declared as a single registration unit.
How to execute modifications related to the "Interpretation of Labeling" section in the instructions for in vitro diagnostic reagents
According to the "Notice of the General Administration Office on Issues Related to Textual Changes in the Instructions for In Vitro Diagnostic Reagents" (Food and Drug Administration Equipment Management [2016] No. 117), textual changes in the informative content of instructions for in vitro diagnostic reagents can be modified by the registrant themselves, including the "Interpretation of Labeling" section in the instructions for in vitro diagnostic reagents. If the registrant improves the interpretation of corresponding labels in the instructions for in vitro diagnostic reagents according to the YY/T0466 series of standards, resulting in changes to this content but not involving other changes requiring permission, the registrant should make the modifications themselves. Here, the YY/T0466 series of standards refers to either the YY/T0466 series of standards or the corresponding ISO 15223 standard. If the registrant makes modifications themselves, they should provide an explanation upon renewal of registration.
What clinical evaluation data should be submitted for polyurethane foam dressings
For polyurethane foam dressings that meet the conditions of the "Revised Catalog of Medical Devices Exempt from Clinical Trials," applicants should submit comparative data between the declared product information and the content described in the catalog, as well as a comparative explanation of the declared product with domestically registered medical devices approved in the catalog and corresponding supportive data. For polyurethane foam dressings not within the scope of the exemption list, applicants should, while meeting the requirements of registration regulations, select appropriate clinical data of similar products according to the "Technical Guidance Principles for Clinical Evaluation of Medical Devices" for clinical evaluation and issue a clinical evaluation report as required by these guidelines. Applicants can also confirm the safety and effectiveness of the product's clinical application through clinical trials. If conducting clinical trials, considerations should include the purpose of the clinical trial, study population, selection of control groups (if necessary), sample size estimation, evaluation of assessment indicators and quantification methods, statistical analysis methods, and other related aspects.
If the applicant's name has changed and the report issued by a third-party organization shows the applicant's name as the previous name, can the report still be used?
The applicant must provide detailed documentation explaining the process of this change, along with supporting evidence. If it is merely a textual change in the name, the third-party report can still be used. If there has been a substantive change in the applicant, documents must be provided to prove that the current applicant can legally use the report. Additionally, an evaluation should be conducted to determine if this change has a substantive impact on the report's results.
Can frozen samples be used in clinical trials of in vitro diagnostic reagents?
In clinical trials of in vitro diagnostic reagent products, case samples that meet the inclusion criteria need to be used for testing. When selecting specific samples for inclusion, attention should be paid not only to the selection of cases (see the common question "Common Issues Regarding Case Samples for Clinical Trials of In Vitro Diagnostic Reagents"), but also to the storage conditions of the samples. In principle, the use of clinical trial samples should closely match the status of samples during the clinical use of the reagent. For example, if samples are freshly collected for testing during clinical use, fresh samples should be considered for the clinical trial. If there may be sample storage processes during clinical use (such as freezing under certain conditions), and the instructions specify the corresponding sample storage conditions and expiration dates, samples under these storage conditions can also be included in the clinical trial. Whether using freshly collected samples or frozen samples, it is essential to ensure that the storage conditions and duration of the samples for inclusion comply with the requirements for storing the respective product samples.
When changes occur in medical devices, in what situations should their biocompatibility be reassessed?
Cases where the biocompatibility of medical devices needs to be reassessed include: (1) Changes in the source of materials or technological conditions used in manufacturing the product; (2) Changes in product formulation, processes, primary packaging, or sterilization; (3) Changes in the final product during storage period, such as alterations in storage period and/or transportation conditions; (4) Changes in the intended use of the product; (5) Signs indicating that the product may cause adverse reactions in the human body.
How should the registration units for artificial ligaments, artificial tendons, and artificial tendon membranes be divided?
Artificial ligaments are used to strengthen natural ligaments or for ligament repair, artificial tendons are used for tendon repair, and artificial tendon membranes are used for tendon membrane repair. Since they have different scopes of application and intended uses, they should be divided into separate registration units. Products made of different materials should be categorized into different registration units. If components of a product (such as screws for artificial ligaments) are made of different materials but are used as a whole assembly or in combination, they can be declared under the same registration unit.
For the App (user analysis software) in the continuous glucose monitoring system product composition, if the Android version of the App is registered and an iOS version is added, is it necessary to register, test, and submit clinical data?
Adding an iOS version of the App requires testing in conjunction with the host device and submitting software research data for the iOS version of the App in accordance with the "Guiding Principles for the Technical Review of Medical Device Software Registration." If the software's functionality remains unchanged and only the operating environment changes, clinical data submission may not be necessary. Otherwise, clinical evaluation data must be submitted in accordance with the "Guiding Principles for the Clinical Evaluation of Medical Devices."
How should the registration units for synthetic resin denture products be divided?
Synthetic resin teeth are mainly made from acrylic ester polymers and are used in the production of partial and full dentures, replacing missing or damaged teeth to form an artificial dental arch, restoring the external shape of teeth, and chewing function. Products with different main chemical compositions should be divided into different registration units, while products with only different color shades can be declared as a single registration unit. Products with different key production manufacturing processes and forming methods should be divided into different registration units (such as compression molding, injection molding, 3D printing, CAD/CAM, etc.). Products with different key performance indicators due to different modification mechanisms from traditional materials should be divided into different registration units (e.g., surface hardness, wear resistance, etc.). Products with different clinical application technologies should be divided into different registration units.