FDA issued 2015 qualification and Certification Guide for small medical device enterprises
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Last Update: 2014-08-11
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Source: Internet
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Author: User
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Source: aozida 2014-08-11 Eastern time August 1, 2014, the U.S Food and Drug Administration released the "2015 financial year qualification and Certification Guide for small medical device enterprises" on its official website, which clearly stipulated the time limit requirements and data requirements for applying for small enterprise qualification According to the FDA, "small business" refers to the business with annual sales less than US $100 million Enterprises meeting this requirement can apply to FDA for small enterprise qualification Once approved by FDA as a small enterprise, the enterprise can enjoy the reduction of device review fee (such as 510k review fee) and the opportunity to obtain a pre market application fee (such as PMA application) for free For example, for the 510 (k) application in fiscal year 2015, the standard charge is usd5018, and for small enterprises, the charge is usd2509; for the PMA application in fiscal year 2015, the standard charge is usd250895, and for small enterprises, the charge is usd62724 It can be seen that enterprises with small enterprise qualification really need to pay a lot less than ordinary enterprises However, for the annual fee, ordinary enterprises and small enterprises have to pay the same amount Compared with the charges in fy2014, see the table below: when applying for the qualification certification of small enterprises to FDA, enterprises need to submit a 3602a form Form 3602a consists of three parts, the first and second parts are completed by the enterprise itself, and the third part is completed by the local national taxation authority The validity period of qualification certification for small enterprises is limited to the fiscal year of the year, and enterprises need to apply for it year by year
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