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The importance and benefits of filing 510(K)

1. One-time fee, no subsequent fee

2. If the company makes any change, K number will remain unchanged, which belongs to the company's permanent intangible fixed assets

3. When a company is listed or acquired, it is usually valued at at least 10 times the value of its fixed assets

4. K is approved without any subsequent work and is held permanently

PS: THE FDA financial budget announces the fee standard of the next year around August every year, and the annual fee increase standard is 5-10%. The later the registration cost is, the higher the regulatory requirements are.

510(K) Main submissions

• Applicant information -- applicant's name, address, etc

• Product description - Product name, grade, shape and structure, purpose of use and other product information

• Labeling, information about sterilization

• Perfomance Standard: Describes the performance standards applicable to the product

• Material evidence of substantial equality

• Test inspection report: data on test inspection results of performance and bioconformance

510(K) Premarket license content

PMA requires additional information for safety and effectiveness audits in addition to general matters, and additional GMP on-site audits for final approval

• Preclinical Laboratory Testing Data

- Tests on physical, chemical and mechanical properties of instruments and materials

- Biological conformance tests such as toxicity tests for materials

• Animal Testing Data

- New materials are suitable for deformed materials, artificial pacemakers, etc

• Human Clinical Testing Data

The importance and benefits of filing 510(K)

510(K) Main submissions

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400-0569-812