On August 1, 2014, US Eastern Time, the U.S. Food and Drug Administration issued a “Guide to the Qualification and Certification of Medical Device Small Business Companies in FY2015†document on the official website of the U.S. Food and Drug Administration. The requirements are clearly defined.
According to FDA regulations, "small businesses" are companies that have annual sales of less than $100 million. In compliance with this condition, companies can apply to FDA for the qualification of small businesses. Once approved by FDA's Small Business Qualification, companies can enjoy a reduction in equipment review fees (such as a 510k review fee) and a free opportunity to obtain a Premarket Application (such as a PMA application).
For example, for the 510(k) application in fiscal year 2015, the standard fee is USD5018, the small business fee is USD2509; for FY2015, the standard fee is USD250,895, and the small business fee is USD62,724. It can be seen that the fees paid by companies with small business qualifications are indeed much lower than those of ordinary enterprises. However, for annual fees, the amount that ordinary companies and small businesses have to pay is the same.
When applying to the FDA for certification of a small business qualification, the company must submit a 3602A form. The 3602A table consists of three parts, of which the first and second parts are completed by the company itself, and the third part is completed by the National Taxing Authority. The period of validity of a small business qualification certification is limited to the fiscal year of the current year, and companies need to apply year by year.
Freeze-drying powder process includes: fresh fruit selection - cleaning - cutting - blanching - cooling - drying - grinding beating - gel grinding - sterilization - pre-freezing - vacuum freeze-drying - ultra-fine grinding - weighing packaging - testing - finished product.
Firstly, fresh and mature fruits with good quality were selected in the pre-treatment area of the food lyophilizer, and the leaves were removed to remove impurities. Then, preliminary cleaning and simultaneous sterilization of fruit surface were carried out. After sterilization, the fruits were cleaned and drained again. After the drain, the fruit is sliced and treated by blanching process. After the color preservation, the fruit is treated by pulping, and then pasteurized. The pretreatment process is finished before lyophilization.
The processing core of freeze-drying powder is the equipment area of food freeze-drying machine. After pre-treatment, the fruit enters the equipment of food freeze-drying machine and crystallizes into a solid state at low temperature, and then sublimates and dries in a vacuum environment to obtain freeze-drying products with little water content. Freeze-dried products out of the warehouse into the food freeze-dried post-processing area, ultrafine grinding, and then according to the need to do weighing packaging, after testing the finished products packed into storage.
Freeze-Dried Half Of Fruit,Mulberry Fruit Powder,Freeze Orange Powder,Raspberry Freeze Dried Powder
Shaanxi HuiKe Botanical Development Co.,Ltd , https://www.oasis-hk.com