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Rui Enni helps a company in Dongguan obtain FDA 510k registration for ultrasonic atomizer In February 2023, Rui Enni submitted a 510 (k) application for an atomizer, and after efforts, it finally passed the FDA review at the end of November and obtained the US market qualification. In recent years, there have been very few records of nebulizers approved by the FDA. The entire respiratory therapy series of products has received special attention from the FDA, with very strict evaluation standards that make it difficult for consulting firms and manufacturers to handle.   Below is a brief sharing of the problems and experiences encountered during the application process.1. Applicable standards for 510k: Number Category Standard Number 1 Electrical safety IEC 60601-1 2 Electromagnetic Compatibility IEC   60601-1-2 3 software IEC 62304 4 Household Electrical Safety IEC 60601-1-11 5 risk ISO 14971&   ISO TR24971 6 Biocompatibility ISO 10993 series standards (depending on actual testing projects) 7 Gas path biocompatibility ISO   18562-1/-2/-3 8 Cleaning/Disinfection FDA Medical Device Reprocessing Guidelines and Corresponding Standards 9 Particle characteristics FDA Nebulizer Guidelines, United States Pharmacopeia 10 performance standard ISO 27427   2. Biocompatibility requirementsBased on nebulizers, drugs are atomized and deposited into the respiratory tract or lungs through respiration. The biocompatibility of drug pathways such as medication cups, masks, and hoses is classified as permanent (>30 days) external access devices that come into contact with tissues. Therefore, its biocompatibility requirements are high, and in addition to the basic three items, more biocompatibility tests need to be conducted according to the requirements of Table A.1 of ISO 10993-1. Alternatively, chemical characterization and toxicological evaluation can be used instead of partial testing, such as chronic toxicity and genetic toxicity. Special attention should be paid to achieving exhaustive extraction in the testing of chemical characterization, and multiple standard substances should be selected for quantitative analysis in the analysis of organic compounds.3. Biocompatibility requirements for respiratory pathwaysThe atomizer still has a gas pathway, so it needs to be tested according to the ISO 18562 series standards based on the actual situation. In the process of conducting these tests, the main issues are that the testing conditions and methods should be clear and complete, and the results should be as detailed as possible. For example, VOC testing should ensure that it reaches a stable state or is below the allowable intake, and the worst-case exposure within the expected lifespan should be considered during the testing process.4. Characteristics of atomized particlesThe aerosol performance testing of nebulizers is also a key focus of FDA attention. According to the FDA's guidelines for nebulizer evaluation, it should include at least three tests on the particle size distribution of nebulized drugs. The FDA approved atomization particle test is a multi-stage impact test method, which is different from the laser scattering method commonly used in our domestic testing. At present, there are few laboratories in China with testing equipment, methods, and experience in FDA approval, so the choice of laboratory is very important.5. Lifespan characteristicsThe impact of the lifespan of atomizers on atomized particles and their impact on cleaning and disinfection is also a concern for the FDA. In the past, it was easy for everyone to prove the product's compliance through verification after making a prototype. However, this approach often only proves that the product meets the corresponding validation requirements, but cannot prove that the product meets the corresponding validation requirements throughout its entire lifecycle. Finally, to summarize, for some medical devices that receive high attention from the FDA, the FDA has very high requirements for testing reports. Choosing a laboratory with successful experience and rich technical experience will be very important. With the increasingly strict FDA review, the review has now shifted from product descriptive information and accuracy to verification and confirmation reports. So the era of having no problems as long as a laboratory report is obtained, as developed in domestic registration and CE registration, is over.Similarly, choosing a consulting firm with experience in the same product is also a very important factor for the success of the project. Rui Enni Consulting has completed dozens of domestic, CE, and FDA projects for disposable atomizers, compression atomizers, ultrasonic atomizers, and mesh atomizers. I have accumulated rich practical experience in the characteristics of atomizers, and some consultants have also worked in companies in the atomizer industry. These experiences will help Ryan Ni better provide consulting services for atomizer companies.

A certain enterprise in Shenzhen is a medical device manufacturer that integrates research and development with production. The company focuses on innovation and research and development of low-frequency therapeutic devices (TENS and EMS). After years of unremitting research and exploration, several series of low-frequency therapeutic devices have been developed. Such as wired, rechargeable, wireless, remote control, Bluetooth connected, and low-frequency therapy devices with heating function.The NMPA registration cooperation between the company's low-frequency therapeutic device and Ruini took 6 months from submission to approval to obtain the certificate.  

The client in Guangdong for this tutoring is located in Guangzhou. The client independently develops, produces, and sells thermometers, blood pressure monitors, ultrasonic nebulizers, IPL hair removal devices, oximeters, ventilators, etc. The customer's products are exported both domestically and internationally, and they have signed dozens of domestic, US, and EU registration and accuracy verification contracts with Ruini for their products; Obtained NMPA registration certificate after 8 months!

The customer is a well-known manufacturer of blood pressure monitors, and this MDSAP certification includes five member countries. The products include electronic blood pressure monitors (arm and wrist). Throughout the entire coaching process, our company dispatched two system consultants for comprehensive guidance. During the coaching process, they patiently provided guidance on QMS systematization, regulatory conversion, design and development modules, and ultimately successfully obtained the MDSAP certificate.

The customer is an electronic blood pressure monitor and infrared thermometer manufacturer headquartered in Dongguan and with a factory located in Jiangxi. The Korean client of the client requested KFDA certification. Upon receiving the commission, our company immediately planned a practical and detailed system coaching plan, and dispatched two system consultants for coaching. With mutual trust and active cooperation from both parties, we successfully obtained the KGMP audit from South Korea and obtained the certificate smoothly. The entire coaching cycle is 3.5 months.

The client is a high-tech enterprise in Shenzhen and a well-known brand in the medical beauty industry. The enterprise adopts a commissioned production model, and during the MDSAP certification coaching, the certificate holder and two commissioned production enterprises participated in the scope of this certification.The product range includes IPL hair removal devices and radiofrequency skin therapy devices. The entire tutoring period is 3.5 months, and during the synchronization process, the KGMP system was also tutored. Through our company's reasonable system coaching plan, three system consultants were dispatched to provide on-site coaching, successfully completing the preparation and review within the expected period of the client, and obtaining the certificate smoothly.