FDA Certification

In order to receive FDA approval for a drug or a high-risk medical device, a drug's or device's manufacturer must prove to the FDA that the item is "safe and effective." Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.

The FDA does not do its own testing of new drugs, medical devices, or other items. Instead, it reviews the results of clinical testing and studies performed by the item's manufacturer. The FDA approval process requires the manufacturer to work with the FDA during human trials of drugs and other devices to ensure trials meet rigorous scientific standards and that human subjects are protected from unnecessary risks. The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer's clinical trials and other research. Based on this analysis, the agency decides whether or not to approve a drug or medical device for a particular use.

We have developed a comprehensive FDA Compliance guidlines which help you to attain an international FDA Certification, this gives your customers an added confidence in using your products.