The management of medical devices by the FDA is carried out through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging, and distributors of medical devices to comply with legal regulations in their business activities.
The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, all of which are under FDA supervision. Based on their medical use and potential harm to the human body, the FDA classifies medical devices into categories I, II, and III, with higher categories providing more supervision.
If the product is a novel invention that has never existed in the market, the FDA requires manufacturers to conduct rigorous human experiments and have convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.
The FDA certification of medical devices includes: manufacturer registration with FDA, product registration with FDA, product launch registration (510 form registration), product launch approval (PMA review), labeling and technical modification, customs clearance, registration, and pre launch report of medical and health devices. The following materials must be submitted: (1) five complete packaged finished products, (2) device construction drawings and text descriptions, (3) device performance and working principle; (4) Safety demonstration or test materials of the device, (5) Introduction to manufacturing process, (6) Summary of clinical trials, (7) Product manual If the device has radioactive properties or releases radioactive substances, a detailed description must be provided.
Factory and product registration of medical devices
The FDA has a clear and strict definition of medical devices, Its definition is 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: those clearly listed in the National Formula or the United States Pharmacopeia or the appendices of the aforementioned two; those expected to be used for the diagnosis of animal or human diseases, or other physical conditions, or for the cure, alleviation, and treatment of diseases Those who affect the functions or structures of animals or human bodies, but do not achieve their main objectives through metabolism.
Only products that meet the above definition are considered medical devices. Under this definition, not only various instruments and tools in hospitals, but also fitness equipment such as eyeglass frames, eyeglasses, toothbrushes, and massagers that consumers can purchase in general stores, are within the scope of FDA's management. It is slightly different from the recognition of medical devices in China.
According to different risk levels, the FDA classifies medical devices into three categories (I, II, III), with Class III having the highest risk level. The FDA has clearly defined the product classification and management requirements for each type of medical device, and there are over 1700 types in the FDA medical device product catalog. Any medical device that wants to enter the US market must first clarify the classification and management requirements of the products applied for listing.
The FDA has formulated many bills for medical devices, which are amended and supplemented from time to time, but there are not many fundamental bills, mainly including the Federal Food, Drug, and Cosmetic Act (FD&C Act); Public Health Services Act; Fair Packaging and Labeling Act; Health and Safety Radiation Control Act; Safety Medical Device Act; Modernization Act. The FDA has provided very detailed explanations and specific operational requirements for these bills. Before planning to enter the US market, companies need to carefully evaluate the regulations and specific requirements related to their products (including different US product standard requirements).
After clarifying the above information, enterprises can start preparing relevant application materials and follow certain procedures to apply to the FDA for approval and recognition. For any product, companies need to register and list their products. For Class I products (accounting for about 47%), General Control is implemented, and the vast majority of products only need to be registered, listed, and implement GMP regulations to enter the US market (with very few products even exempt from GMP, and very few retained products requiring a 510 (K) application or PMN (Pre market Notification) to be submitted to the FDA); For Class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises also need to implement GMP and submit 510 (K) applications (very few products are exempt from 510 (K)); For Class III products (accounting for about 7%), pre market licensing is implemented. After registration and listing, enterprises must implement GMP and submit a PMA (Pre market Application) application to the FDA (some Class III products are still PMN).
For Class I products, after the enterprise submits relevant materials to the FDA, the FDA only makes announcements and does not issue relevant documents to the enterprise; For Class II and III devices, enterprises must submit PMN or PMA. At the same time as the announcement, the FDA will provide the enterprise with a formal market access approval letter (Clearance), which allows the enterprise to directly sell its products in the US medical device market under its own name. As for whether to conduct on-site GMP assessment at the enterprise during the application process, it is determined by the FDA based on comprehensive factors such as product risk level, management requirements, and market feedback.
Based on the above content, it can be seen that the vast majority of products can obtain FDA approval for listing after enterprise registration, product listing, and implementation of GMP, or after submitting a 510 (K) application.
The 1.510 (K) file, also known as the document required by the FDA for PMN, is commonly referred to as the 510 (K) file due to its corresponding FD&C Act section 510.
2. Substantial Equality Comparison (SE)
3.510 (K) Review Procedure
Before applying, it is necessary to clarify whether the product is recognized by the FDA as a medical device, product category, management requirements, and the scope of application work;
Check whether there are mandatory standards in the United States for products applying for listing, and whether the products comply with these standards (usually requiring formal inspection reports from testing agencies);
Before preparing the 510 (K) application documents, it is necessary to consider whether it is truly necessary to submit, when to submit, and which nature of 510 (K) application to submit: regular 510 (K), special 510 (K), simplified 510 (K);
Provide timely written and timely answers to questions raised by the FDA during the application process;
All documents submitted to the FDA should use Letter Size (21.5cm X 29.7cm) for paper size;
All companies submitting materials to the FDA must keep a backup, as the FDA electronically scans and logs in the application materials upon receipt, and destroys the application materials without returning them to the company.
For a small number of products, the FDA will conduct on-site GMP assessments on enterprises. Enterprises need to refer to the US GMP management requirements and be equipped with appropriate translators who have a certain understanding of GMP and the enterprise during FDA on-site audits;
Inform the official contact person of the FDA that they need to have a certain understanding of FDA regulations and work procedures, and be able to communicate directly with the FDA for timely feedback. Enterprises can clarify their own or entrust consulting agencies to be responsible for daily communication with the FDA.