FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site
Today, the U.S. Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. This site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data to support those decisions.
The new Web site is part of an ongoing effort within FDA to enhance communication and transparency. This Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as:
- basic information about medical devices and how FDA regulates those products
- information about medical devices before and after the products are on the market, in a searchable database
- information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices
- memos from FDA employees explaining the reasons for the agency’s decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device
- a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process
CDRH plans to add new information about premarket submissions, product performance & safety, compliance & enforcement, and science & research to this website monthly.
The Web site includes a feedback feature that will allow CDRH to collect input and suggestions from the public about the information provided. Visit the CDRH Transparency Web site at www.fda.gov/CDRHTransparency and let us know what you think. Feedback provided will be used to improve and expand the website.
Afia Asamoah
Transparency Initiative Coordinator
I had a severe post-surgical complication that I’m convinced was related to a subcutaneous local anesthetic pump and/or its contents, but that’s not how the ER doc or hospitalist classified my visit – one in which they were admittedly not familiar with the equipment. I believe I would have been one of the 700+ statistics had they not removed the pump, which they did only after failing to determine any other cause of the extreme hypotension & bradycardia.
Is anyone investigating or tracking near misses?
The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.
Thanx
It’s good when we can see transparency..Thanks a lot!
Not only is transparency valued by the public when it comes to the approval or disapproval of medical devices but the fact that the public is allowed to give input is extremely valuable in opening communication and coming up with relevant solutions.
Transparency on medical devices is really important.
Transparency on medical devices is really important.
An excellent addition to the FDA site. Transparency regarding medical devices is very important and needed.
Here’s another great action that will certainly contribute for improve transparency. If consumers trust FDA this will be better for all. You’re doing a great job!
Very informative and it has helped me a lot. A round of aplause. Thank you.
Creating web sites for multiple small business, this is going to help me a lot in my day to day work! Thanks much!
The more the public knows first hand about these issues the better we all will be.
Absolutely pent written content, appreciate it for selective information. “Necessity is the mother of taking chances.” by Mark Twain.