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How prepare FDA 510 (K) application file
From;    Author:Stand originally
How to prepare medical apparatus and instruments 510 (K) application file

1. 510(K) file also namely the file that FDA requires to PMN place, because its are corresponding FD&C Act the 510th paragraphic, friend says normally 510 (K) file. Right 510 (K) the information that file place must contain, FDA has a main demand, its content is as follows roughly 16 respects:

1) application cases,
2) catalog,
3) authenticity assures to state;
4) equipment name;
5) register number;
6) classification;
7) performance standard;
[the others content is omitted, the detail is contacted with my department please]

2. Equal sex compares essence (SE)

It is essence is equal that the product that equal sex compares essence is the product that should prove to apply for to appear on the market and lawful on American market already sale is compared in security and effectiveness respect. Choosing right product to undertake comparative is 510 (K) the crucial step of application. Below the Ying Congru when undertaking comparative the respect has a consideration:
[content is omitted, the detail is contacted with my department please]

The enterprise must offer enough data proof, the appliance that applies for to appear on the market and by relative appliance it is essence is equal (SE) , otherwise 510 (K) application won't be passed.

3. 510 (K) examine a program

FDA is in those who receive an enterprise to hand over 510 (K) after the data, examine a data above all all ready, if the data is complete, be accepted and give out to the enterprise affirm a gender, application gives out to accept number in the meantime (K YYXXXX) , this number also will serve as the number after be being approved formally; Be like not all ready, ask the business is additional inside formulary time all ready, make an enterprise abandon handling otherwise. FDA enters in-house work order namely after accepting application, still can ask the business is a few more additional possibly among them data. Be in 510 (K) after application passes check and approve, FDA does not give out approval correspondence instantly, however according to product risk grade, market before whether to the enterprise bad report waits to whether undertake to the enterprise spot GMP is assessed certainly, the reappearance after assessment is passed approves correspondence formally to the enterprise (Clearance) ; If beardless spot assesses GMP, criterion 510 (K) formal approval sends correspondence instantly after application is passed.

To a few problems that the attention requires when FDA applies for

1. The product must be made clear to whether be identified by FDA before application demand of category of medical apparatus and instruments, product, government, apply for working content clearly;

2. Have to applying for the product that appear on the market to consult deny American compulsive standard, whether does the product accord with this standard
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