FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
STAT

FDA warns medical device makers about rise in fabricated data

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by ...
MD&M East

Database System to Boost FDA’s Postmarket Surveillance Capability

(click to enlarge)A potential organizational structure for FDA's Sentinel initiative. It can take a long time for FDA to piece together medical device reports (MDRs) and other data to determine that ...
Medical Xpress

As FDA slashes workforce, number of new medical devices reaching the public has fallen

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...
The American Journal of Managed Care

Time to Publication of Cost-effectiveness Analyses for Medical Devices

This study examines the availability of cost-effectiveness analyses for medical devices, both in terms of the number of studies and when studies are published. Objectives: Academic researchers and ...