How to Get FDA Approval | 合法醫療器材資訊網

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2017年1月17日 — FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical ... Read More

2021年3月3日 — How to know if a medical device is FDA-approved, cleared, or authorized. The FDA does NOT issue registration certificates. Read More

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, ... Read More

2020年8月12日 — FDA's export certification provides the agency's official attestation concerning a product's regulatory or marketing status, based on ... Read More

2020年8月30日 — How to register facilities and products, and how to update registrations. Animal and Veterinary. Domestic and foreign establishments that ... Read More

FDA regulates the sale of medical device products in the U.S. and monitors the safety ... Jun 30 - FDA recommends using only FDA-cleared or NIOSH-approved ... Read More

FDA Learning Portal for Students, Academia, and Industry. Find education and resources related to FDA's regulatory, product quality, and safety ... Read More

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may ... Read More