CFDA: Ophthalmic Optical Coherence Tomography Registration Technical Review Guidelines Released

On March 2, in order to strengthen the supervision and guidance of the registration of medical device products and further improve the quality of registration examination, the State Food and Drug Administration organized the “Guidelines for the Technical Review of Ophthalmic Optical Coherence Tomography Registration”, which is hereby released.

Ophthalmic optical coherence tomography registration technical review guidelines

This guideline is intended to guide registered applicants in the preparation and writing of Ophthalmic Optical Coherence Tomography (OCT) registration application materials, and also provides a reference for the technical review department to review the registration application materials.

This guideline is a general requirement for ophthalmic OCT. Applicants should determine whether the content is applicable based on the specific characteristics of the product. If not applicable, the reasons and corresponding scientific basis should be specified, and the contents of the registration application materials should be enriched and refined according to the specific characteristics of the products.

Because the current mainstream OCT is based on the principle of frequency domain coherence, this guideline mainly considers the OCT using the frequency domain coherence principle. For the OCT adopting the time domain coherence principle or other working principles, this guideline can be referred to.

This guiding principle is a guiding document for registered applicants and technical reviewers, but does not include administrative matters involved in the review and approval, and is not enforced as a regulation. The guidelines should be used in compliance with relevant regulations. . If there are other methods that can meet the relevant regulatory requirements, it can also be used, but detailed research materials and verification materials are required.

This guiding principle is formulated under the current regulations and standards system and the current level of cognition. With the continuous improvement of laws and standards, and the continuous development of science and technology, relevant content will be adjusted in a timely manner.

First, the working principle (only in the frequency domain OCT as an example)

The ophthalmic optical coherence tomography is to measure and calculate the backscattered light from the ocular tissue by optical interference of near-infrared light to generate an ocular tissue tomographic image. When light enters the human eye from infinity, part of the light is absorbed by the tissue in the eye, and the remaining light is reflected or scattered by the tissue. This partially reflected or scattered light is received by the optical coherence tomography scanner and filtered by the principle of optical coherence. Unless the stray light is generated by a particular tissue, the light is highly selective and clearly imaged for a particular tissue being examined. Ophthalmic optical coherence tomography images the tissue by different reflection, absorption and scattering abilities of various tissues in the eye to achieve a clear resolution of the tissue structure.

Second, the registration unit division

The division of the registration unit shall comply with the requirements of the relevant guiding principles, and in principle shall be based on the technical principle, structural composition, performance indicators and applicable scope of the product. In general, if the different models are only functional, they can be used as a registration unit. For example, the OCT of the anterior segment and fundus retina can be combined with the anterior segment OCT or the fundus retina OCT as a registration unit; OCT for different intended uses. Can not be used as a registration unit, such as OCT for the anterior segment of the eye and OCT for the fundus retina should be registered separately; OCT of different working principles can not be used as a registration unit, such as frequency domain OCT, time domain OCT, sweep source OCT should be respectively registered.

Third, the list of medical equipment safety and effective basic requirements

The applicability of the clauses in the list of requirements for the safety and effective basic requirements of medical devices is referred to Appendix 1. Applicants can judge according to the characteristics of products, and the methods used to prove compliance and the documents providing objective evidence for compliance are filled in by the applicant according to the actual situation. Evidence provided for compliance, if included in the product registration filing, should indicate its specific location in the filing. For example: VIII, registration inspection report (medical electrical safety: protective part of mechanical risk); Chapter 4.2 of the manual. For documents not included in the product registration declaration, the name of the evidence document and its number in the quality management system document shall be indicated for future reference.

Fourth, the main points of review

(1) Product name

The product name consists of a core word and no more than three characteristic words. The core word of the ophthalmic optical coherence tomography scanner is “scanner”. The three characteristic words are “ophthalmology”, “optical coherence” and “fault”, which are indispensable. It can also be named "Ophthalmic Optical Coherence Tomography". If there is a product name different from the above, the product name should be given the basis for naming.

(2) Structural composition

The product structure may include an optical host, a power supply section, a chin rest portion, an anterior segment adapter (optional), non-embedded software, and the like. For non-embedded software, the software name and version number should be specified in the composition; for embedded software, it is not necessary to enumerate in the structure, but the software release version and the full version naming rules should be specified in the product technical requirements. If the product must be used in conjunction with the computer during the clinical examination, regardless of whether the computer is part of the product, the brand and specification of the computer to be used shall be limited and shall be consistent with the computer used in the electromagnetic compatibility test.

(3) Intended use and contraindications

Ophthalmic OCT is used for tomographic imaging of the anterior segment of the eye and/or posterior segment of the eye, and is used by trained personnel. The anterior segment OCT can be used for tomography of the cornea and the anterior chamber. It can be achieved by adding an anterior segment adapter to the OCT of the posterior segment of the eye, as well as an OCT device dedicated to the anterior segment of the eye. Posterior segment OCT is mainly used for retinal tomography, if other analysis (such as glaucoma progression analysis), imaging (such as fundus imaging, vascular imaging) or measurement (such as retinal thickness measurement, macular thickness measurement) function, can also be expected Described in the use, but should be supported by the corresponding technical data and clinical evaluation data.

Product contraindications are patients who have received photodynamic therapy within 48 hours. Extreme caution should be exercised in OCT examinations for high-risk populations of light radiation hazards, aphakic eyes, infants, or patients who are not sensitive to light caused by fundus diseases.

(4) Summary information

1. The main functions of the product, the functions of the various components, and the characteristics that distinguish it from similar products should be described. The difference between the characteristics of similar products is the focus of technical review, such as the analysis function, measurement function, vascular imaging, colorful, etc. compared with similar products; or the source wavelength is different, the scanning resolution is improved, and scanning is compared with similar products. Features such as speed increase. In addition, the product should be described in the background of research and development, how to achieve, what is the meaning of improvement, what technical problems or clinical problems are solved.

2. The reference similar products or predecessors should provide information on similar products (listed at home and abroad) or previous generation products, and explain the research background and purpose of the application for registration. For similar products, the reason for choosing it as a reference for research and development should be explained. At the same time, the list shows the similarities and differences between the application for registration products and reference products (similar products or predecessors) in terms of working principle, structural composition, performance indicators and scope of application.

(5) Research data

1. Product performance study

Product performance study data and product technical requirements should be provided for research and development instructions, including functional, safety indicators, and other indicators related to quality control, the criteria or methods used, the reasons for the use, and the theoretical basis. The basis for determining the function and performance indicators in the research data should be clear and specific, and cannot be described in a general way as “based on product characteristics” and “determined according to clinical needs”. The product characteristics and clinical needs should be specified. For the reference of similar products, relevant information of similar products should be provided. For some indicators set according to national standards and industry standards, attention should be paid to whether specific requirements (such as numerical values) are given in the standard. For those who do not give specific requirements, the applicant should explain the basis for determining the functions and performance indicators of the declared products. , that is, the reason for the design input determination.

2. Biocompatibility evaluation study

Biocompatibility evaluation should be carried out on the materials in the OCT that are in contact with the patient and the user. If the user wears gloves, the biocompatibility evaluation may not be performed on the part that the user touches, but it should be clearly stated in the specification that the user needs Wear gloves to operate." If the sputum and the forehead part are to be used in conjunction with the pallet paper and the forehead paper, and the patient is not in direct contact with the patient, the biocompatibility evaluation may not be performed, but it should be clearly stated in the specification. If the sputum part is in direct contact with the patient, the biocompatibility evaluation study data should be provided in accordance with the regulations, and attention should be paid to the following aspects:

(1) Biocompatibility evaluation should evaluate the materials in the finished product rather than the raw materials. Some materials production and processing processes may change the biocompatibility results of the materials, such as adding processing aids or processing processes (such as high temperature) have changed. The nature of the raw materials.

(2) The biological test report in the research data may provide a domestic test report or an overseas test report. The domestic test report may be a commission test, and the test report shall include sample preparation methods, test methods and test results. Biological tests conducted within the territory shall be commissioned by biological laboratories with medical device inspection qualifications and within the scope of their inspection in accordance with relevant standards; biological laboratory reports issued by foreign laboratories shall be accompanied by foreign laboratories. It meets the quality assurance documentation required by the GLP laboratory.

(3) The biological test report shall reflect the product name and model and correspond to the declared product. If a report on other products is provided, the difference between the tested product and the declared product should be evaluated. It should be proved that the raw materials and sources, production processes, etc. affect the biocompatibility re-evaluation.

3. Sterilization/disinfection process research

Ophthalmology OCT is an outpatient examination and diagnosis equipment. It is generally not used in the operating room. It is in contact with healthy skin on the surface of the human body. It does not need to be sterilized. It can be disinfected according to the routine equipment of the hospital. The research data of sterilization/disinfection process may not be provided. However, if the product composition contains accessories that need to be sterilized, the corresponding research materials should be provided in accordance with the regulations.

4. Product life study

The service life of OCT is generally mainly determined by the loss of components and components during use, aging, etc. Applicants should perform aging/fatigue tests on the equipment according to the claimed service life, or aging the key components that affect the service life of the equipment. Fatigue tests, such as parts that are not replaceable (or costly to replace) in the equipment, and provide appropriate research data. The research data should demonstrate that the OCT's product performance and safety are still in accordance with the expected requirements after the aging/fatigue test. The period of use can also be reasonably inferred, analyzed, and calculated based on existing data, but detailed instructions and supporting information should be provided.

5. Software research

Applicants should provide corresponding software research materials in accordance with the regulations and the Guiding Principles for the Registration of Medical Device Software Registration (National Food and Drug Administration Circular No. 50 of 2015). The technical review focuses on whether the software research data meets the requirements of the Medical Device Software Registration Technical Review Guidelines, whether the requirements specifications are consistent with the software functions, whether the software verification and validation report conclusions are passed, whether there are remaining defects and residual risks. Acceptable. If the product composition includes both embedded software and stand-alone software, whether the corresponding information is provided for all software.

6. Optical radiation safety research data

Products containing light sources should provide research data on optical radiation safety. For ophthalmic OCT, applicants can provide ISO 15004-2 "Ophthalmic Instruments - Basic Requirements and Test Methods - Part 2: Photohazard Protection" test report (may be The self-inspection report, the entrusted inspection report or the registration inspection report may also be an overseas inspection report, or other research materials that can prove the safety of light radiation to the human eye.

7. Environmental test

The transportation, storage and use environment will affect the performance of optical products. Therefore, applicants should provide research data on environmental tests, and may also conduct registration tests. After the environmental test, the test provisions should at least include core indicators such as power and resolution at the cornea.

(6) Clinical evaluation data

Ophthalmic OCT is an opto-mechatronics product with complex hardware and software technology. Currently, it is not included in the second category of medical device exemption from clinical trials. Applicants may conduct analysis and evaluation according to the data obtained from clinical trials or clinical use of medical devices of the same type in accordance with the Technical Guidelines for Clinical Evaluation of Medical Devices (Notified by the State Food and Drug Administration, No. 14 of 2015). The items in Attachment 2 should be included. The review should pay attention to whether the clinical evaluation includes all the declared models. Can the comparison between the declared products and the products of the same variety prove that the two are basically equivalent, whether the supporting materials of the same variety are sufficient, whether the performance parameters are comprehensive, and whether the core components are comprehensive. Equivalent. For ophthalmic optical products, the assembly and installation process has a significant impact on product performance, and the review should also focus on whether the production process is equivalent.

If the comparison data (including supporting data) of the declared product and the same variety of products can prove that the two are basically equivalent, it is necessary to check whether the clinical data of the same variety is sufficient, and whether the products used in the clinical data are comparative products of the same variety. Non-other products (the application product is A, the comparison product is B, and the submitted clinical data is product C), and the scope of application in the clinical data is consistent with the scope of application of the registration application (application product A and comparison product B) Substantially equivalent, but only provides clinical data of the scope of application of Part B of the product, then A can only approve the registration of the same part of the scope of B).

The comparison data (including supporting data) between the declared product and the same product cannot prove that the two are basically equivalent. The applicant should evaluate whether the difference has adverse effects on the safety and effectiveness of the product, and can report the product's own data. Verification and/or validation, such as non-clinical research data, clinical literature data, clinical experience data, and clinical trial data for differences in China. In the review, the focus is on whether the evaluation information for the difference is sufficient.

Applicants who fail to provide clinical evaluation data in accordance with the above requirements shall be in accordance with the requirements of the "Quality Management Regulations for Clinical Instruments Clinical Trials" (National Food and Drug Administration, National Health and Family Planning Commission Order No. 25), in two (including) The above clinical trial institutions conduct clinical trials. For clinical trials, if the model number of the clinical trial is a typical model, clinical evaluation should be carried out for other models in the same registration unit. Clinical trials can be paired with the application of two different instruments (test and control instruments) to the same subject. The control equipment should be preferred to use similar products. For those who cannot select the same type of products for the control test, the applicant should discuss the reasons. Clinical trials can be designed for non-inferiority comparisons, with no special requirements for randomization, but it is recommended to blind the evaluators. In the review, it is considered whether the subjects in the clinical trial program, control selection, boundary value selection, test hypothesis, blind method, evaluation index (reproducibility, image quality consistency, etc.) are reasonable; whether statistical considerations are sufficient, including samples Whether the quantity meets the statistical requirements, whether the test results are adequately statistically analyzed, whether the multi-center clinical trial plan is consistent (including whether the control group is consistent); whether the clinical trial conclusion is clear, and the safety of the intended use of the declared product is safe. Whether the sexual/validity evaluation index reaches the preset end point, and the risk of the product is acceptable relative to the expected return, and can meet the demand for clinical use. If there are adverse events during the clinical trial, the sponsor shall record the adverse events and analyze whether they are related to the test equipment.

(VII) Risk analysis

OCT-related hazards include energy hazards, biological hazards, environmental hazards, hazards associated with operational use, software hazards, ergonomic hazards, functional failures, hazards from maintenance and aging. In the review process, the safety analysis should be combined with the safety and effectiveness checklist to check whether the risk analysis is complete, and whether the risk control measures taken can effectively reduce the risk and whether the remaining risks are acceptable. The format of the risk analysis report can be referred to Appendix 3, and the contents listed in Appendix 3 are only examples. The applicant should adjust and improve according to the characteristics of the product.

(8) Product technical requirements

The technical requirements of the product mainly include the performance requirements of tomography, the performance requirements of the measurement (if any), the performance requirements of the light source, the functional requirements of the software, the electrical safety requirements, the electromagnetic compatibility requirements, the environmental test requirements, and the 11 safety products. Features, software release versions, and naming rules. For models with multiple specifications, the differences between the models should be clarified.

1. The performance of tomography includes the depth of the scan, the lateral resolution and the longitudinal resolution of the scan in the tissue (should be optical resolution rather than digital resolution, measured rather than calculated, no tolerance), scan speed (frequency) The diopter adjustment range, the angle of view (if applicable), and the positional consistency of the image surface on which the image is displayed on the image surface and the mark is OCT scanned. If the product integrates the function of the fundus camera, refer to the relevant requirements of YY 0634-2008 "Ophthalmic Instrument Fundus Camera".

2. Performance requirements for measurements include measurement accuracy and measurement repeatability.

3. The performance requirements of the light source include the wavelength of the light source and the working distance of all the light sources (scanning light source, illumination light source, measuring light source, etc.) of the device.

4. The functions of the software mainly include software analysis and calculation functions, data management functions, scanning modes, etc. For functions that require clinical verification (for example, room angle observation and vascular imaging), it is not suitable to be formulated in product technical requirements.

5. The electrical safety requirements mainly include GB 9706.1. If the product composition contains a computer, or the product belongs to the category of the system in GB 9706.15, the applicability of GB 9706.15 should also be considered.

6. Electromagnetic compatibility shall comply with the requirements of YY 0505.

7. If the laser source contains laser light, the applicability of GB 7247.1 should be considered.

8. The environmental test shall be carried out in accordance with GB/T 14710. The technical requirements of the product shall specify the conditions of the environmental test and the items to be tested.

9. Other functions and performance claimed by the applicant.

This guideline only gives the reference function and performance requirements, and the specific parameters are formulated and verified by the applicant. The preparation of product technical requirements is shown in Appendix 4. The test methods for functions and performance indicators are recommended and are not mandatory. Applicants can develop their own test methods. The test methods developed by themselves should be given at the same time. The origin of the test method or the analysis of the rationality and feasibility.

(9) Registration inspection report

1. The technical review focuses on whether the specifications and structure of the inspection report are consistent with the application form, and whether the terms in the inspection report are consistent with the technical requirements of the product (including indicators and tolerances).

2. For imported products, if the applicant fails to carry out the whole test of GB 9706.1-2007 in China, the IEC 60601-1 full test report issued by the overseas testing agency shall be provided at the same time. The version of IEC 60601-1 in the report shall be It is consistent with the international version corresponding to GB 9706.1-2007. If submitting the electrical safety test report issued by the overseas testing agency, the applicant shall submit the qualification certificate of the testing institution at the same time, which proves that the institution has the ability to carry out the full testing according to the IEC 60601-1 standard. The technical review focuses on whether the specifications, product composition, and production address of the overseas inspection report are consistent with the application content.

3. For the same registration unit with multiple specifications and models, the most complex structure, the most functional, and the highest index should be selected as the typical model for performance and electrical safety testing. EMC testing is reported independently and should be linked to performance and electrical safety inspection reports.

4. The basic information (voltage, frequency, etc.) of the product in the electromagnetic compatibility report, the equipment used in combination, and the group classification shall be consistent with the relevant contents such as the manual.

5. The product type in the EMC report is generally a desktop device. However, if the product composition includes a workbench, it should be tested according to the floor-standing device. If the workbench is an optional accessory, it should be tested according to the desktop device and the floor-standing device. .

6. If the product in the instruction manual is classified as Class B according to GB 4824, harmonic distortion, voltage fluctuation and flicker in electromagnetic compatibility shall be applied and tested.

(10) Instructions and labels

The instructions and labels shall comply with the requirements of the instructions and labels in the Medical Device Manual and Label Management Regulations (Order No. 6 of the State Food and Drug Administration), GB 9706.1 and YY 0505, and shall include the period of use, revision of the instructions or The date of preparation, basic performance and other details, the description of the basic performance should not contain the words "test or test". Technical parameters, group classification, etc. should be consistent with product technical requirements and test reports.

Fifth, the writing unit

Center for Medical Device Technology Evaluation of the State Food and Drug Administration. (CFDA)

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