About the medical equipment FDA attestation

FDA on the management of medical equipment by the device and radiological health center ( CDRH ) for the supervision of the center, medical equipment production, packaging, dealers in compliance with the law of business activities. FDA sterilization process validation information guide ( English ) medical equipment range is very wide, small to large to medical gloves, cardiac pacemaker, are under surveillance of FDA, according to the medical use and possibly to human body injury, FDA medical equipment is divided into I, II, III, the higher the supervision more categories.
If the product is on the market did not exist before new invention, FDA manufacturers require strict human experimentation, and convincing medical and statistical evidence of efficacy and safety of the products.
Medical equipment FDA certification, including: manufacturers registered in FDA, FDA products, product registration registration ( 510 meter register ), product approval ( PMA audit ) health care equipment and technological transformation, customs clearance, label, before listing registration report, shall submit the following materials:
( 1) the complete package of products five,
( 2 ) equipment structure diagram and text,
( 3) equipment performance and work principle;
( 4) equipment safety argumentation or test material,
( 5) manufacturing process,
( 6) clinical trials is summarized,
( 7) product description. If the instrument has a radiation performance or the release of radioactive material, should be described in.
Medical equipment common products
- X ray diagnostic categories of medical products (general purpose, fluorescent X ray, CT etc.)
- operation and other types of laser equipment and laser unit equipment
- special purpose laser products ( including display, observation and medical)
Ultraviolet therapy ( medical equipment with ultraviolet light and products )
Non - physical therapy and diagnosis of other medical ultrasound equipment
Microwave diathermy and microwave blood heater
Ultrasonic physiotherapy equipment
Medical equipment factory and product registration
FDA on medical devices has a clear and rigorous definition, which is defined as follows:" the so-called medical equipment refers to accord with the following condition of instrument, apparatus, machinery, tools, instruments, is inserted into the pipe, in vitro reagent and other related items, including components, parts or accessories: clear out on National Formulary or the Unite States Pharmacopeia or above two appendix; intended to animal or human disease, or other physical condition or for disease diagnosis, cure, mitigation and treatment; expectancy effects in animal or human body structure or function, but not by the new supersedes the old. To achieve its main objective".
Only with the above definition of products is regarded as a medical instrument, in this definition, not only within the hospital of various instruments and tools, even the consumers in general store to buy the glasses frame, eyeglasses, toothbrush with massage fitness equipment belong to the scope of management FDA. It is with domestic medical devices that are slightly different.
According to the risk degree of different medical devices, FDA will be divided into three types (I, II, III, III ) the highest risk grade. FDA will each kind of medical equipment are clearly defined the product classification and management requirements, the FDA medical instrument product catalog of 1700 kinds of. Any kind of medical equipment to enter the American market, we must first find application for the listing of product classification and management requirements.
FDA for the medical device developed by many bills, and constantly modify and supplement, but the underlying bill is not much, mainly including: the federal food, drug and Cosmetic Act ( FD&C Act, fundamental act); the public health service act; fair packaging and Labeling Act; health and safety radiation control act; the safe medical devices act; modernization act. Of these bills, FDA gave a very detailed explanation, and supporting a specific operating requirements. Enterprises in the plan to enter the American market, need to be carefully evaluated for their products relevant regulations and specific requirements ( including different American product standards ).
In the above information, the enterprise can begin to prepare the declaration data, and according to a certain procedure to the FDA declaration to obtain approval. For any product, enterprise needs to undertake business registration ( Registration ) and listing ( Listing ). On the categories of products ( 47% or so), is the implementation of the general control ( General Control ), the vast majority of products only need to register, listing and implementation of GMP specification, product to enter the American market ( one of the very few products even GMP immunity, few retention products are required to submit 510 ( FDA K ) application PMN ( Premarket Notification ) ); for class II products ( 46% or so), is the implementation of special control ( Special Control ), enterprises are in registration and listing, also need to implement GMP and submit 510 ( K ) application ( some products are 510 ( K ); exemption ) on products (7% left and right ), implementation of the premarket approval, enterprises are in registration and listing, required to implement GMP and FDA to submit PMA ( Premarket Application ) application ( Part III products or PMN ).
On the categories of products, enterprises to the FDA to submit relevant information, FDA only notice, there is no relevant documents issued to the enterprise; on, class III devices, the enterprise must submit PMN or PMA, FDA declared at the same time, to the enterprise market access to formal approval letter ( Clearance ), which allows the company to own in the name of the United States medical equipment market for direct sales of its products. As for the application process is to corporate on-site assessment by FDA GMP, according to product risk level, management requirements and market feedback and other factors to decide.
Contents above knowable, the vast majority of products in the enterprise registration, listing and implement GMP, or to submit 510 ( K ) after the application is approved by FDA, can be listed.
1.510 ( K ) file that FDA to PMN files needed, because of the corresponding FD&C Act 510th chapters, it is usually called the 510 ( K ) file.
2 substantially equivalent comparison ( SE )
3.510 ( K ) review procedure
Prior to the application must be clear whether the product is FDA recognized as medical equipment, product category, management requirements, clear job application content;
On the application of the listed products to the United States are not mandatory standard, whether the products meet the standards ( General requirements testing agency official inspection report );
In preparation for the 510 ( K ) application documents, need to consider the real need to submit, when submitting and submit what kind of nature of the 510 ( K ) 510 ( K ) application: regular, special 510 ( K ), 510 ( K );
On the application of FDA in the process of the problems should be given in writing, a timely answer;
All information submitted to the FDA paper size should be using Letter Size ( 21.5cmX29.7cm );
All submitted FDA information enterprises need to keep a copy, because the FDA in receipt of the application materials, electronic scan log, while destroying the application data, does not return enterprises.
A small fraction of the product, FDA will enterprises to conduct on-site GMP assessment, enterprises need to refer to the United States of America GMP management requirements, and in the FDA field when the audit is equipped with the right, on the GMP and enterprises have a certain understanding of the translator;
Inform FDA official contacts of FDA regulations and work procedures have a certain understanding, and can communicate directly with FDA, to facilitate the timely feedback, enterprise can be clear or commissioned by the advisory body responsible for daily communication with FDA