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(19)& (11)EP 2 322 558 A1EUROPEAN PATENT APPLICATION(12) (43) Date of publication:(51) Int Cl.:C07K 16/28 (2006.01)18.05.2011 Bulletin 2011/20(21) Application number: 10184690.5 (22) Date of filing:
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De novo design refers to the process of creating a new product or process from scratch, utilizing novel concepts and approaches, especially in healthcare and technology fields.
Entities or individuals who wish to market a new device that is not substantially equivalent to an existing device must file a de novo design with the regulatory authority.
Filing a de novo design typically requires completing a specific form provided by the regulatory authority, including detailed descriptions of the product, intended use, and safety and effectiveness information.
The purpose of de novo design filings is to classify new devices that are low to moderate risk and do not fit existing categories, allowing them to be reviewed and authorized for market entry.
Key information includes product description, proposed labeling, risk analysis, clinical data, and details about the manufacturing process.
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