Medical device FDA certification
The FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which oversees the manufacture, packaging, and distribution of medical devices in compliance with the law.
FDA Sterilization Process Validation Information Guide (English)
Medical devices range from small medical gloves to large cardiac pacemakers, all under FDA oversight. Based on medical use and possible harm to the human body, the FDA classifies medical devices as Class I, II, or III, with the higher the category the more oversight.
If the product is a novel invention that does not exist in the marketplace, the FDA requires the manufacturer to conduct rigorous human trials and have compelling medical and statistical evidence of the product's effectiveness and safety.
Medical device FDA certification, including: manufacturers in the FDA registration, product FDA registration, product listing registration (Form 510 registration), product listing review and approval (PMA audit) Healthcare device labeling and technical modifications, customs clearance, registration, pre-market report, the following materials must be submitted:
(1) five copies of the finished product with complete packaging,
(2) the device construction and design of the device. p>(2) the structure of the device and its text description,
(3) the performance of the device and the principle of operation;
(4) the device's safety demonstration or test materials,
(5) the manufacturing process,
(6) a summary of the clinical trials,
(7) the product specification. If the device has radioactive energy or release radioactive material, must be described in detail.
Factory and product registration of medical devices
The FDA has a clear and strict definition of a medical device, which is defined as follows: "A medical device is an instrument, apparatus, tool, machine, appliance, insertion tube, in-vitro reagent, and other related articles, including components, parts, or accessories, that are: (a) expressly listed in the National Formulary or the Uniformed Services; or (b) expressly listed on the National Formulary or the Uniformed Services. National Formulary or the Unite States Pharmacopeia, or the appendices to the foregoing; intended for use in the diagnosis of disease or other physical conditions in animals or human beings, or for the cure, mitigation, or treatment of disease; and intended to affect the function or structure of the body of animals or human beings without metabolizing them to achieve its primary purpose. ".
Only products that meet the above definition are considered medical devices. Under this definition, not only are all kinds of instruments and tools used in hospitals, but even eyeglass frames, eyeglass lenses, toothbrushes, and fitness equipment such as massagers, etc., which can be purchased by consumers in general stores, fall within the scope of the FDA's management. It is slightly different from the domestic recognition of medical devices.
Based on the different levels of risk, the FDA divides medical devices into three classes (I, II, III), with Class III having the highest level of risk.
The FDA clearly defines the product classification and management requirements for each type of medical device. The FDA has clearly defined the product classification and management requirements for each medical device, and any medical device that wants to enter the U.S. market must first be clear about the product classification and management requirements for the application.
The FDA has developed many bills for medical devices, and from time to time to modify and supplement, but the fundamental bill is not much, including: the Federal Food, Drug & Cosmetic Act (FD&C Act, the fundamental bill); the Public Health Service Act; the Fair Packaging and Labeling Act; the Health and Safety Radiation Control Act; the Safe Medical Devices Act; the Modernization Act. For these acts, FDA gives a very detailed explanation, and supporting specific operational requirements. Companies planning to enter the U.S. market need to carefully evaluate their product-related regulations and specific requirements (including the requirements of different U.S. product standards).
After clarifying the above information, companies can begin to prepare the relevant filings and follow certain procedures to file with the FDA to obtain approval. For any product, the enterprise needs to carry out enterprise registration (Registration) and product listing (Listing). Class I products (accounting for about 47%), the implementation of the general control (General Control), the vast majority of products only need to be registered, listed and the implementation of GMP specifications, the product can enter the U.S. market (a very small number of products are exempted from the GMP, a very small number of reserved products need to be submitted to the FDA 510 (K) application that is, the PMN (Premarket) Notification)); for Class II products (about 46%), the implementation of special control (Special Control), enterprises in the registration and listing, but also need to implement GMP and submit 510 (K) application (very few products are 510 (K) exemption); for Class III products (about 7%), the implementation of the pre-market licensing, the enterprise registration and listing, must implement GMP and submit 510 (K) application (very few products are 510 (K) exemption); for Class III products (7%), the implementation of pre-market licensing, the enterprise registration and listing, the implementation of GMP and 510 (K) application. For Class III products (about 7%), the implementation of pre-market authorization, companies in the registration and listing, the implementation of GMP and submit to the FDA PMA (Premarket Application) application (some Class III products or PMN).
For Class I products, enterprises submit relevant information to the FDA, the FDA only announcement, and no relevant documents issued to the enterprise; for Class II and III devices, enterprises shall submit PMN or PMA, the FDA in the announcement at the same time, the FDA will give the enterprise to the formal approval of the market access letter (Clearance), that is, to allow the enterprise to their own name in the U.S. medical device market direct sales of their products. sell their products in the U.S. medical device market directly under their own name. As to whether the application process to the enterprise for on-site GMP assessment, the FDA based on product risk level, management requirements and market feedback and other comprehensive factors to decide.
Consolidating the above content can be seen, the vast majority of products in the enterprise registration, product listing and implementation of GMP, or then submit a 510 (K) application, can be approved by the FDA to market.
1. 510 (K) documents, that is, the FDA PMN required documents, because of its corresponding FD&C Act Chapter 510, it is usually referred to as 510 (K) documents.
2. Substantial Equivalence Comparison (SE)
3. 510 (K) review process
In the pre-application must be clear whether the product is recognized by the FDA as a medical device, product categories, management requirements, clear application for the content of the work;
Application for marketing of the product access to the U.S. mandatory standards, the product is consistent with the standard (generally require formal inspection reports of testing organizations);
Application for marketing of products to see if there is a U.S. mandatory standards, whether the product meets the standards (generally require testing)
Before preparing the 510(K) application documents, you need to consider whether you really need to submit, when to submit, and which nature of the 510(K) application: regular 510(K), special 510(K), simplified 510(K);
The FDA in the process of the application of the question should be given in writing in a timely manner, timely answer.
The paper size of all information submitted to the FDA should be Letter Size (21.5cm X 29.7cm);
All the information submitted to the FDA enterprises need to keep a backup, because the FDA in the receipt of the application information that is electronically scanned logged in at the same time, the destruction of the application information, and will not be returned to the enterprise.
For a small number of products, the FDA will conduct on-site GMP assessment of enterprises, enterprises need to refer to the U.S. GMP management requirements, and in the FDA on-site audits are equipped with appropriate, the GMP and the enterprise has a certain understanding of the interpreter;
To inform the FDA of the official contact person to the FDA need to have a certain degree of understanding of the FDA regulations and work procedures, and to communicate directly with the FDA, to facilitate timely feedback. facilitate timely feedback, and companies can specify their own or entrust a consulting organization to be responsible for daily communication with the FDA.