Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) ...

WASHINGTON -- Roughly 3,000 medical devices enter the U.S. market every year through a system generally requiring little or no patient testing to verify safety and effectiveness. Unlike new ...

As Medical Devices have continued to innovate, embedded software has grown. Software, artificial intelligence (AI), and machine learning (ML) are now a part of nearly every medical device. These ...

The American Telemedicine Association, the College of Healthcare Information Management Executives (CHIME) and Otsuka America Pharmaceutical are among the groups in support of the Centers for Medicare ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...

MDDAP is a tailored version of the CMMI framework and provides a model and method by which medical device manufactures can better understand, measure, and improve their capability to develop high ...

An accelerated regulatory pathway in Mexico has positioned the country as a priority launch market for medical devices. Guerreschi: This pathway is designed to reduce approval timelines by the Federal ...