FDA’s performance management system, FDA-TRACK, allows the public to track the agency’s progress on a range of measures, including whether the agency is hitting its inspection targets and whether it is hitting its targets for completing reviews of product applications (see April 7 blog post).
New performance data is now available on FDA-TRACK. Check out FDA-TRACK for updates from November 2010, including updates on the number of Freedom of Information Act (FOIA) requests processed in FY 2010 and the agency’s progress filling vacancies on FDA advisory committees.
Afia Asamoah, Transparency Initiative Coordinator
Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’. The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008). The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date. You can find the database here.
We encourage your feedback on the database and welcome your suggestions for additional information you would like to see. You can provide feedback on the FDA Web site.
Afia Asamoah, Transparency Initiative Coordinator
FDA has posted a video explaining FDA-TRACK, the performance management system the agency launched in April (see April 7 blog post). FDA-TRACK is a web resource that provides information about the breadth of FDA's activities to promote and protect the public health.
The video features FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein and FDA Center Directors Drs. Bernadette Dunham and Janet Woodcock. View the video below, then check out the information currently available on FDA-TRACK about FDA's progress on a range of activities and let us know what you think.
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.
Transparency Initiative Coordinator
Today, FDA launched a new website that will help the public understand the breadth of FDA's core responsibilities to promote and protect the public health. The website is called FDA-TRACK: Agency-wide Program Performance. FDA-TRACK is FDA's new agency-wide performance management and accountability tool.
The FDA-TRACK website will allow you to gain insights about:
- Each of our program offices and what they do
- Each program office's key performance goals and projects
On a quarterly basis, each FDA program office will submit monthly performance data and present that information to FDA senior leadership. This information will be posted on the FDA-TRACK website and the public can track this information and monitor the accomplishments and trends for each key program area.
Visit the FDA-TRACK website resource at http://www.fda.gov/fdatrack and let us know what you think. You can suggest changes and let us know if you found the information to be useful by emailing FDATRACK@fda.hhs.gov. Feedback you provide may be used to improve the program.
Malcolm Bertoni, Assistant Commissioner for Planning at FDA
As part of the final phase of the Transparency Initiative, we are looking for ideas from the public on how FDA can increase transparency with regulated industry, in order to foster a more effective and efficient regulatory process. These comments will be used to inform draft recommendations the Task Force will put forward this spring on ways FDA may improve transparency to regulated industry.
FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency – biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines – are integral to public health and to the U.S. economy.
The Task Force held public meetings in June 2009 and November 2009. Based upon input received so far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and FDA intends to issue draft proposals for public comment soon.
For this final phase, we are particularly interested in comments on how FDA can make improvements in certain areas. The first area we would like to hear comments about is:
What training and education should FDA provide for regulated industry about the regulatory process in general, or about new requirements?
We will post additional topics over the next couple of weeks.
We look forward to your ideas.
Transparency Task Force