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FDA Medical Device Registration

Author:admin Release time:2022-04-12 16:17:05Click:
definition
 
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 articles, including components, parts or accessories, which are clearly listed in the appendix of national formula or the United States pharmaceutical or both of the above; Intended for the diagnosis of animal or human diseases or other physical conditions, or for the cure, mitigation and treatment of diseases; Those who are expected to affect the physical function or structure of animals or human bodies, but do not achieve their main purpose through metabolism ". Only products that meet the above definition can be regarded as medical devices. Under this definition, not only various 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 identification of medical devices in China.

FDA has established a classification system for more than 1700 medical devices, which are divided into three categories based on risk and product use.
 
a) Type I conventional control (exempt, no exempt)
 
b) Class II conventional control and special control (exemption, no exemption)
 
c) Category III routine control and pre market approval
 
Among them, class I products have the lowest risk and class III products have the highest risk.
 
If the product is classified as class I or class II and belongs to the exemption category, the enterprise registration + product listing can be legally sold;
 
If the product is classified as class I or class II and there is no exemption, it needs to comply with 510k before listing;
 
If the products are classified as class III, most of them need pre marketing approval application (PMA), and a few products can meet 510k.
 
How to determine product classification
 
FDA provides a classified database for public query
 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
 
Query the classification according to the registered product information database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm

other
 
The FDA logo cannot be used on the product;
 
FDA medical product registration query link:
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
 
Enter the corresponding owner / operator number to query;
 
30-90 days after registration or Fei number registration, FDA will assign it to the enterprise;
 
The annual fee needs to be paid to FDA every year, and the annual fee amount is different every year, which shall be subject to the issued by FDA;
 
If the product is no longer sold in the United States, the annual fee may not be paid;
 
Generally, enterprise registration and product listing can be completed in 1 to 2 weeks.
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