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 ...

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...

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 ...

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 ...

Bipartisan senators introduced the Health Tech Investment Act (S. 1399), which would establish a Medicare reimbursement pathway for FDA-cleared medical devices that utilize artificial intelligence and ...

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 ...