FDA medical registration

Product introduction： FDA's management of medical devices is carried out through the device and radiation health center (CDRH), which supervises the production, packaging and business activities of dealers of medical devices in compliance with the law.A wide range of medical devices, ranging from medical gloves to cardiac pacemaker, are under the supervision of FDA. According to the medical use and possible harm to human body, FDA divides medical devices into categories I, II and III. The higher the category, the more supervision.If the product is a novel invention that does not exist in the market, FDA requires the manufacturer to conduct strict human experiments and have convincing medical and statistical evidence to show the effectiveness and safety of the product.FDA certification of medical devices, including: Manufacturer's registration with FDA, product FDA registration, product listing registration (510 form registration), product listing review and approval (PMA review), label and technical transformation, customs clearance, registration and pre marketing report of medical and health devices, the following materials must be submitted: (1) five copies of finished products with complete packaging, (2) device structure diagram and text description, (3) device performance and working principle; (4) Safety demonstration or test materials of the device, (5) introduction to manufacturing process, (6) summary of clinical trial, (7) product specification If the device has radioactive properties or releases radioactive substances, it must be described in detail.Factory and product registration of medical devicesFDA has a clear and strict definition of medical devices, It is defined as follows: 'The so-called medical devices refer to the instruments, devices, tools, machinery, appliances, insertion tubes, in vitro reagents and other related articles, including components, parts or accessories that meet the following conditions: those explicitly listed in the appendix of national formula or the United States Pharmacopeia or both; those expected to be used in the diagnosis of animal or human diseases, or other physical conditions, or for the cure, mitigation and treatment of diseases; and It refers to the physical function or structure of an animal or human body, but does not achieve its main purpose through metabolism '.Only products that meet the above definition can be regarded as medical devices. Under this definition, not only all kinds of instruments and tools in the hospital, but also fitness equipment such as spectacle frames, spectacle lenses, toothbrushes and massagers that consumers can buy in general stores belong to the management scope of FDA. It is slightly different from the domestic identification of medical devices.According to different risk levels, FDA divides medical devices into three categories (I, II and III), and category III has the highest risk level. FDA clearly stipulates the product classification and management requirements of each medical device. There are more than 1700 kinds of FDA medical device product catalogue. If any kind of medical device wants to enter the American market, it must first clarify the classification and management requirements of the products applying for listing.FDA has formulated many bills for medical devices, which are revised and supplemented from time to time, but there are few basic bills, mainly including: the federal food, drug and Cosmetics Act (FD & C act); Public health services act; Fair packaging and Labeling Act; Health and safety radiation control act; Safe medical devices act; Modernization Act. The FDA has given a very detailed explanation of these bills, with specific operational requirements. Before planning to enter the U.S. market, enterprises need to carefully evaluate the regulations and specific requirements related to their products (including different U.S. product standard requirements).After clarifying the above information, enterprises can start to prepare relevant application materials and report to FDA according to certain procedures to obtain approval. For any product, the enterprise needs to carry out enterprise registration and product listing. For class I products (accounting for about 47%), general control is implemented. Most products only need to be registered, listed and implement GMP specifications, and the products can enter the U.S. market (very few products are exempted from GMP, and very few reserved products need to submit 510 (k) application to FDA, namely PMN (premarket notification)); For class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises need to implement GMP and submit 510 (k) application (510 (k) exemption for very few products); For class III products (accounting for about 7%), the pre marketing license is implemented. After registration and listing, the enterprise must implement GMP and submit PMA (premarket application) application to FDA (some class III products are still PMN).For class I products, after the enterprise submits relevant materials to FDA, FDA only makes an announcement and does not issue relevant certificates to the enterprise; For class II and III devices, enterprises must submit PMN or PMA. While announcing, FDA will give enterprises a formal market access approval letter (clearance), that is, enterprises are allowed to directly sell their products in the American Medical Device Market in their own name. Whether to go to the enterprise for on-site GMP assessment during the application process is determined by FDA according to comprehensive factors such as product risk level, management requirements and market feedback.It can be seen from the above that most products can be approved by FDA for listing after enterprise registration, product listing and GMP implementation, or after submitting 510 (k) application.1.510 (k) document, that is, the document required by FDA for PMN, is usually called 510 (k) document because of its corresponding FD & C act chapter 510.2. Substantive equality comparison (SE)3.510 (k) review procedureBefore the application, it must be clear whether the product is recognized as a medical device by FDA, product category, management requirements, and the content of the application;Check whether there is a mandatory standard in the United States for the products applying for listing and whether the products meet the standard (generally, the formal inspection report of the testing organization is required);Before preparing 510 (k) application documents, it is necessary to consider whether it is really necessary to submit, when to submit and what kind of 510 (k) application to submit: regular 510 (k), special 510 (k) and simplified 510 (k);The questions raised by FDA during the application process shall be answered in writing and in time;The paper size of all materials submitted to FDA shall be letter size (21.5cm x 29.7cm);All data submitted to FDA shall be kept in backup by the enterprise, because FDA will scan and log in electronically after receiving the application data, destroy the application data at the same time, and will not return it to the enterprise.For a small number of products, FDA will conduct on-site GMP assessment on enterprises. Enterprises need to refer to the GMP management requirements of the United States, and provide appropriate translators with a certain understanding of GMP and enterprises during FDA on-site audit;Inform the official contact person of FDA that they need to have a certain understanding of FDA regulations and working procedures, and can communicate directly with FDA to facilitate timely feedback. The enterprise can clarify itself or entrust a consulting agency to be responsible for daily communication with FDA.

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FDA's management of medical devices is carried out through the device and radiation health center (CDRH), which supervises the production, packaging and business activities of dealers of medical devices in compliance with the law.

A wide range of medical devices, ranging from medical gloves to cardiac pacemaker, are under the supervision of FDA. According to the medical use and possible harm to human body, FDA divides medical devices into categories I, II and III. The higher the category, the more supervision.

If the product is a novel invention that does not exist in the market, FDA requires the manufacturer to conduct strict human experiments and have convincing medical and statistical evidence to show the effectiveness and safety of the product.

FDA certification of medical devices, including: Manufacturer's registration with FDA, product FDA registration, product listing registration (510 form registration), product listing review and approval (PMA review), label and technical transformation, customs clearance, registration and pre marketing report of medical and health devices, the following materials must be submitted: (1) five copies of finished products with complete packaging, (2) device structure diagram and text description, (3) device performance and working principle; (4) Safety demonstration or test materials of the device, (5) introduction to manufacturing process, (6) summary of clinical trial, (7) product specification If the device has radioactive properties or releases radioactive substances, it must be described in detail.

Factory and product registration of medical devices

FDA has a clear and strict definition of medical devices, It is defined as follows: 'The so-called medical devices refer to the instruments, devices, tools, machinery, appliances, insertion tubes, in vitro reagents and other related articles, including components, parts or accessories that meet the following conditions: those explicitly listed in the appendix of national formula or the United States Pharmacopeia or both; those expected to be used in the diagnosis of animal or human diseases, or other physical conditions, or for the cure, mitigation and treatment of diseases; and It refers to the physical function or structure of an animal or human body, but does not achieve its main purpose through metabolism '.

Only products that meet the above definition can be regarded as medical devices. Under this definition, not only all kinds of instruments and tools in the hospital, but also fitness equipment such as spectacle frames, spectacle lenses, toothbrushes and massagers that consumers can buy in general stores belong to the management scope of FDA. It is slightly different from the domestic identification of medical devices.

According to different risk levels, FDA divides medical devices into three categories (I, II and III), and category III has the highest risk level. FDA clearly stipulates the product classification and management requirements of each medical device. There are more than 1700 kinds of FDA medical device product catalogue. If any kind of medical device wants to enter the American market, it must first clarify the classification and management requirements of the products applying for listing.

FDA has formulated many bills for medical devices, which are revised and supplemented from time to time, but there are few basic bills, mainly including: the federal food, drug and Cosmetics Act (FD & C act); Public health services act; Fair packaging and Labeling Act; Health and safety radiation control act; Safe medical devices act; Modernization Act. The FDA has given a very detailed explanation of these bills, with specific operational requirements. Before planning to enter the U.S. market, enterprises need to carefully evaluate the regulations and specific requirements related to their products (including different U.S. product standard requirements).

After clarifying the above information, enterprises can start to prepare relevant application materials and report to FDA according to certain procedures to obtain approval. For any product, the enterprise needs to carry out enterprise registration and product listing. For class I products (accounting for about 47%), general control is implemented. Most products only need to be registered, listed and implement GMP specifications, and the products can enter the U.S. market (very few products are exempted from GMP, and very few reserved products need to submit 510 (k) application to FDA, namely PMN (premarket notification)); For class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises need to implement GMP and submit 510 (k) application (510 (k) exemption for very few products); For class III products (accounting for about 7%), the pre marketing license is implemented. After registration and listing, the enterprise must implement GMP and submit PMA (premarket application) application to FDA (some class III products are still PMN).

For class I products, after the enterprise submits relevant materials to FDA, FDA only makes an announcement and does not issue relevant certificates to the enterprise; For class II and III devices, enterprises must submit PMN or PMA. While announcing, FDA will give enterprises a formal market access approval letter (clearance), that is, enterprises are allowed to directly sell their products in the American Medical Device Market in their own name. Whether to go to the enterprise for on-site GMP assessment during the application process is determined by FDA according to comprehensive factors such as product risk level, management requirements and market feedback.

It can be seen from the above that most products can be approved by FDA for listing after enterprise registration, product listing and GMP implementation, or after submitting 510 (k) application.

1.510 (k) document, that is, the document required by FDA for PMN, is usually called 510 (k) document because of its corresponding FD & C act chapter 510.

2. Substantive equality comparison (SE)

3.510 (k) review procedure

Before the application, it must be clear whether the product is recognized as a medical device by FDA, product category, management requirements, and the content of the application;

Check whether there is a mandatory standard in the United States for the products applying for listing and whether the products meet the standard (generally, the formal inspection report of the testing organization is required);

Before preparing 510 (k) application documents, it is necessary to consider whether it is really necessary to submit, when to submit and what kind of 510 (k) application to submit: regular 510 (k), special 510 (k) and simplified 510 (k);

The questions raised by FDA during the application process shall be answered in writing and in time;

The paper size of all materials submitted to FDA shall be letter size (21.5cm x 29.7cm);

All data submitted to FDA shall be kept in backup by the enterprise, because FDA will scan and log in electronically after receiving the application data, destroy the application data at the same time, and will not return it to the enterprise.

For a small number of products, FDA will conduct on-site GMP assessment on enterprises. Enterprises need to refer to the GMP management requirements of the United States, and provide appropriate translators with a certain understanding of GMP and enterprises during FDA on-site audit;

Inform the official contact person of FDA that they need to have a certain understanding of FDA regulations and working procedures, and can communicate directly with FDA to facilitate timely feedback. The enterprise can clarify itself or entrust a consulting agency to be responsible for daily communication with FDA.

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