STAT

FDA proposes changes to key approval pathway for medical devices, five years after promising

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) ...
JD Supra

A Pathway for Medicare Coverage for Breakthrough Devices: Take Two

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 ...
MD&M East

Factors Influencing FDA Clearance Time for Medical Devices: Evolution of a Critical Regulatory Pathway

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 ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

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 ...
Fierce Healthcare

Coalition of 33 organizations endorses CMS' proposal to quickly cover new medical devices

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 ...
MD&M East

Mexico’s Shortened Regulatory Timetable Attracts Medical Device Manufacturers

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 ...