FDA certification: The United States Food and Drug Administration is abbreviated as FDA. FDA is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radioactive products produced or imported in the United States. It is one of the earliest federal agencies whose main function is to protect consumers.

The FDA manages medical devices through the Device and Radiation Health Center (CDRH), which oversees the production, packaging, and distributors of medical devices to comply with laws and conduct business activities.

The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, which are under the supervision of FDA. According to medical uses and possible harm to the human body, FDA classifies medical devices into categories Ⅰ, Ⅱ, and Ⅲ. The more categories are monitored. If the product is a novel invention that has never existed on the market, the FDA requires manufacturers to conduct rigorous human experiments and have convincing medical and statistical evidence to demonstrate the product's effectiveness and safety.

FDA certification of medical devices, including: manufacturers registered in FDA, FDA registration of products, product listing registration (Form 510 registration), product listing review approval (PMA review) labeling and technical transformation of medical and health care devices, customs clearance, registration, pre-marketing The report must submit the following materials:

(1) five complete packaging products,

(2) device construction drawing and text description,

(3) device performance and working principle,

(4) device safety demonstration or test materials ,

(5) Introduction to manufacturing process,

(6) Summary of clinical trials,

(7) Product description, if the device has radioactive energy or releases radioactive material, it must be described in detail.

Registration and certification procedures: FDA has a clear and strict definition of medical devices, which is defined as follows: "The so-called medical devices refer to instruments, devices, tools, machinery, appliances, insertion tubes, in vitro reagents and other related items that meet the following conditions, Including components, parts or accessories, which are clearly listed in the National Formulary or the Unite States Pharmacopeia or the aforementioned two appendices, are expected to be used for the diagnosis of animal or human diseases, or other physical conditions, or for the cure, mitigation and Treatment is expected to affect the function or structure of the animal or human body, but does not achieve its main purpose through metabolism. "

Only products that meet the above definition are regarded as medical devices. Under this definition, not only various instruments and tools in the hospital, but also fitness equipment such as eyeglass frames, eyeglass lenses, toothbrushes and massagers that consumers can buy in general stores Etc. are all within the scope of FDA management. It is slightly different from the domestic recognition of medical devices.

According to the different risk levels, FDA classifies medical devices into three categories (Ⅰ, II, and III), with category III having the highest risk level. FDA clearly stipulates its product classification and management requirements for each medical device, and the FDA medical device product catalog has included more than 1,700 products. Any medical device that wants to enter the US market must first clarify the classification and management requirements for the product to be listed.

The FDA has formulated many bills for medical devices, which are revised and supplemented from time to time, but there are not many fundamental bills, mainly including: Federal Food, Drug and Cosmetic Act (FD & C Act, fundamental bill), public health service bill, and fair packaging And Labeling Act, Health and Safety Radiation Control Act, Safe Medical Device Act, Modernization Act. The FDA gave very detailed explanations of these bills, and they were accompanied by specific operational requirements. Before planning to enter the US market, companies need to carefully evaluate the relevant regulations and specific requirements for their products (including different US product standard requirements).

After the above information is clarified, the enterprise can proceed to prepare the relevant declaration materials and apply to the FDA in accordance with 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 implemented GMP regulations, and the products can enter the US market. Exempted, very few reserved products need to submit 510 (K) application (PMN (Premarket Notification)) to FDA; for Class Ⅱ products (about 46%), special control is implemented, companies are registering and After listing, it is necessary to implement GMP and submit 510 (K) applications (very few products are exempted from 510 (K)); for Class III products (approximately 7%), the pre-market licensing is implemented, and enterprises are registering and After listing, you must implement GMP and submit a PMA (Premarket Application) application to the FDA (some Class III products are still PMN).

For class Ⅰ products, after the company submits relevant information to FDA, FDA only makes announcements, and no relevant documents are issued to the company; for class Ⅱ and class Ⅲ devices, companies must submit PMN or PMA, and FDA will give the company A formal market access approval letter (Clearance), which allows companies to sell their products directly on the US medical device market in their own name. As for whether to go to the enterprise for on-site GMP assessment during the application process, it is up to the FDA to determine the comprehensive factors such as product risk level, management requirements and market feedback.

Based on the above, it can be seen that most products can be approved by the FDA after they have undergone enterprise registration, product listing and GMP implementation, or after submitting a 510 (K) application.

1. The 510 (K) document is also the document required by the FDA for PMN. Because it corresponds to Section 510 of the FD & C Act, it is usually called the 510 (K) document;

2. Substantial equality comparison (SE);

3. 510 (K) review procedure.

Before applying, it must be clear whether the product is recognized by the FDA as a medical device, product category, management requirements, and the content of the application work. Check whether the product applied for listing has the US mandatory standard and whether the product meets the standard (generally requires formal inspection by the testing agency report);

Before preparing 510 (K) application documents, you need to consider whether you really need to submit, when to submit, and what kind of 510 (K) application to submit, regular 510 (K), special 510 (K), simplified 510 (K) ;

Written and timely answers to questions raised by FDA during the application process;

Letter size (21.5cm X 29.7cm) should be used for all paper sizes submitted to FDA;

All enterprises submitting information to FDA must keep a copy, because FDA will electronically scan and log in after receiving the application information, and destroy the application information at the same time, and will not return the enterprise.

For a small number of products, FDA will conduct on-site GMP assessment of the enterprise. Enterprises should refer to the US GMP management requirements and be equipped with appropriate translators who have a certain understanding of GMP and the enterprise during the FDA on-site audit.

Inform the FDA's official contact person to have a certain understanding of FDA regulations and work procedures, and be able to communicate directly with FDA to facilitate timely feedback. Companies can clarify themselves or entrust a consulting agency to be responsible for daily communication with FDA.

application process:

1. Business registration

1) Enterprise registration application form:

FDA confirms and publishes the company serial number.

2) Product registration:

Medical device products are divided into 3 categories according to the degree of safety risk:

Class 1, medical device listing control;

Type 2, market access approval (ie 510 (K) approval);

Class 3, approved by PMA before entering the market.

3) Entrusted agent:

"FDA Registration and Notification Commission Agreement" (signed by a legal representative and affixed with the company's official seal).

4) Provide information:

Enterprise legal person business license, business legal person code certificate, corporate legal person registration certificate, etc. (copy with company seal); qualification certificate or production license certificate (copy with company seal), "FDA Registration Application Form" ( One copy each in Chinese and English, with the company's official seal); FDA newly added other documents required to be submitted (if any).

Company profile (time of establishment, economic performance, technical strength, main production varieties and their performance, asset status).

2. Payment

Registration and listing are free;

510 (K), PMA shall be paid according to the charging standard published by FDA online.

3. Register

After the fee is calculated, FDA will complete the registration within 60 working days;

The FDA website announces the registration status, and the FDA of 510 (K) and PMA sends an approval letter.

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