Transparency website aims to improve
This article was originally published in The Silver Sheet
Executive SummaryAfter receiving 46 comments about its new transparency website, CDRH said it will implement certain recommendations to improve it. However, most responders to a survey on the website, launched April 19, said they found it to be very useful. The website now includes links to various device-related databases and the CDRH management directory, and includes information on topics such as health hazard evaluations and health risk assessments. It also recently added a chart that explains to manufacturers and patients how adverse events are processed by the agency. (See "1FDA To Manufacturers: Describe Adverse Events More Fully"
You may also be interested in...
Revised bill released by the US Senate Finance Committee adjusts the manufacturer discount program in Medicare Part D and includes new provisions aimed at easing beneficiary cost sharing obligations.
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.