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  FDA 510K

Medical device FDA510 (K) application
ZCQC has provided 510 (K) application writing and technical support services; ZCQC has successfully accepted a large number of 510K applications in the country and continue to provide professional authority for 510 (K) applications for medical enterprises of different products.
According to FDA requirements, most of the second class products, a small part of the class and three categories of products, FDA medical equipment before registration, the need to submit FDA510 (K) demonstration report to the FDA, to demonstrate the product itself, the safety and effectiveness The FDA510 (K) itself is not registered, is a prerequisite for product FDA registration;
FDA510 (K) involves a large number of FDA regulatory requirements, safety, effectiveness and other requirements, the application needs to apply the test standards, FDA regulations and guidelines are numerous, usually difficult to complete by the manufacturers and individuals, ZCQC based on our On the successful acceptance of various types of products 510K experience and experience, have the ability to provide for the guests 510 (K) to write and related technical support services; to ensure that:
- Submission of 510 (K) file format integrity (ie 510 (K) file administrative audit)
- Compliance with the safety and validity of the 510 (K) file submitted (ie 510 (K) technical review) and try to avoid and reduce FDA review questions
- All product information, test reports, etc. submitted in the 510 (K) file are substantially in line with FDA regulations, standards and guidelines, and there will be no significant omissions and errors;
- We will only submit the FDA review and ensure the smooth approval of the FDA after reviewing, collating and ensuring that all documents and information received comply with FDA regulatory requirements.
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At present, the FDA has increased the difficulty and intensity of FDA review, and any 510 (K) application needs to be approved based on the manufacturer's proficiency in the product and the proficient combination of the service provider. Any person or service provider who is able to obtain 510 (K) approval if you are induced to a very low price and promise no need or have to submit very little information means that you need to face:
- the submission of 510 (K) content is incomplete, the information is false or lack of important hiccups, argument weakness, can not be approved by the FDA, was eventually rejected; wasted your costs and time, but also affected the product as soon as possible to obtain more orders May sometimes lead to supply default;
- Illegal or informed circumstances Illegal use of other manufacturers to apply for 510 (K) documents leading to a violation of legal issues;
- FDA and laboratory audits may be initiated after being found by the FDA;
- is prohibited in the US Customs customs clearance products and require recall products;
- has been approved 510 (K) was canceled;
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More questions are welcome to contact
US FDA Registration Advisory Line: 15602970173 QQ: 2695669655

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