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) ...

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 ...

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), ...

The TCET pathway builds off of prior initiatives including CED. CED is a pathway where CMS uses the NCD process to deny coverage for the item or service except for patients using the item or service ...

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

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic ...

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 ...