NOR-STA in FDA MDDT pilot program

24.09.2015 - 10:42

On September 21st Argevide NOR-STA was accepted for the MDDT (Medical Device Development Tools) pilot program implemented by FDA. Under this program, NOR-STA’s suitability as an assurance case tool supporting the development and evaluation of medical devices will be assessed.

The evaluation process will take a few months. A positive qualification will mean that FDA confirms the usefulness of the tool in ensuring and demonstrating safety of medical devices. For more information about the MDDT program please visit the FDA.

Food and Drug Administration (FDA) is a US government agency which regulates about 25% of the consumer market in the US, including food market, dietary supplements, drugs, cosmetics, medical devices, electromagnetic radiation emitting devices and biological materials. In many cases, a positive qualification of the product is a prerequisite for admittance to the US market. FDA qualification is also recognized outside the United States as a benchmark of quality and confirmation of the absence of negative effects on health.

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