The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...

This course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles. Medical devices go through a long and complex process of development ...

The FDA is set to exempt certain types of software from regulatory oversight as it reconsiders its approach to products on the fringes of the medical device sector. Officials at the agency set out ...

"The new definition for medical devices will be aligned with that of the International Medical Device Regulators Forum and one which is globally accepted," an official said. Once the new definition is ...

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical ...

The domestic medical devices industry in the country has suggested that the definition of manufacturer in the draft New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, to be changed with more ...

In what would translate into streamlining and tightening of regulations of manufacture, sale and distribution of the $2.12-billion medical devices market, the category will get a separate definition ...