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) ...

Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The "Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions (January 15, 2026)" training has been added to ResearchAndMarkets.com's ...

It appears that authors Anika Kumar and colleagues (November 2023) are potentially misinformed about the regulatory landscape in the US. According to the Food and Drug Administration (FDA), ...

CDRH Unveils Medical Device Innovation Pathway Bombarded by demands that it be more supportive of medical product innovation (see, for example, the next story), FDA in February announced its Medical ...

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 ...

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 ...