Oct 20, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and requests associated thereto. The document provides an overview...
Read More
Oct 15, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and regulatory framework associated thereto. Table of Contents Due...
Read More
Sep 12, 2019
North America
The Food and Drugs Administration (FDA), the US authorized body who provides regulation and supervision in the sphere of medical products and devices, finalized a guidance on De Novo applications. De Novo Pathway De Novo is a special procedure applied for new market...
Read More
May 28, 2019
North America
The US FDA announced the launch of a pilot regulatory project related to the “Software as a Medical Device” (SaMD) in the course of amendments to the medical devices certification rules. 2019 Test Plan The development of technologies and regulatory needs are...
Read More
Dec 12, 2018
North America
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this program, products are automatically classified as Class...
Read More