FDA 510k review

NormalTCI testing can enable your medical devices to receive review and approval faster than submitting them directly to the FDA. We offer a greater chance of successful submission of 510k in the first round. By increasing the likelihood of your first successful submission and accelerating the FDA 510 (k) process, we can help you deliver your medical products to customers faster, thereby improving the profitability of your institution.

The medical device products we test

Regarding the FDA 510 (k) review plan

Section 510 (k) of the Food, Drug, and Cosmetic Regulations requires that if a medical device manufacturer intends to introduce a device into commercial circulation for the first time or to introduce a significantly altered or modified device, they must submit a pre-market notification for the applicable device. This process allows the FDA to determine whether the device is identical to an existing device on the market, ensuring the safety and effectiveness of all medical devices on the market.

The FDA 510 (k) third-party review program enables external FDA accredited conformity assessment organizations to conduct 510 (k) reviews. The purpose of this program is to maintain high-quality 510 (k) reviews and shorten review time by utilizing external expertise and resources. The overall efficiency of third-party review schemes enables you to quickly launch products into the market.

Please consult NormalTCI for specific questions

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