April 19, 2010—The US Food and Drug Administration (FDA) announced the launch of the Center for Devices and Radiological Health (CDRH) Transparency Web site as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, as well as summaries of data that provide the rationale for agency actions.
According to the FDA, the new Web site is part of an ongoing effort within the CDRH and across the FDA and Department of Health and Human Services to enhance public communication and transparency. The CDRH’s previous Web site provided information about approved products, industry guidance, medical device safety, and adverse event reports. On the new Web site, additional information is displayed in a more user-friendly format.
The Web site includes information related to the following topics:
- Premarket submissions for approved and cleared products: Summaries of the FDA’s reviews of the documents and data that companies submit to the FDA when requesting clearance or approval to market a new or improved device, and the systems the FDA uses to evaluate these submissions
- Postmarket performance and safety: Documents and data describing how well devices perform after they are on the market and information about how the FDA monitors medical device safety
- Compliance and enforcement: Official actions that the FDA has taken in response to problems with devices or device companies
- Science and research: Research programs at the CDRH or sponsored by the CDRH
- Educational resources: Information to help industry and others understand CDRH requirements and processes
- CDRH performance data: Metrics about CDRH programs
- Total Product Life Cycle database: Integrates premarket and postmarket medical device information from multiple data sources into a single snapshot
The Web site includes a feedback feature that will allow the FDA to collect input and suggestions from the public about the information provided. In the coming months, the FDA will expand the CDRH Transparency Web site to include premarket approval and clearance reviews.
“The CDRH Transparency Web site gives the public a window into our work,” commented CDRH Director Jeffrey Shuren, MD. “It provides a closer and clearer look at what we do and why we do it.”
In other news, on April 19, the European Commission announced the adoption of a decision that will oblige all European Union (EU) countries to use a European databank for medical devices (Eudamed) as of May 2011. Although these devices are traded on the European single market, data that are key to their safety—such as conformity certificates and data on clinical investigations—are for the time being collected only at the national level. The Eudamed databank is a secure information technology tool that will ensure rapid access to such data by market surveillance authorities. The databank will also streamline the rules for manufacturers placing in vitro diagnostic devices on the market. More information is available on the EU Web site. Commissioner in charge of Health and Consumer Policy John Dalli commented, “Today's decision means good news for patients across the EU. It will lead to increased patients’ safety thanks to rapid access to critical data by national authorities.”
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By David Wolford, MD, FACC
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This classification and intervention scoring system was created to provide precise treatment to the target vessel and optimize outcomes.
By J. A. Mustapha, MD, FACC, FSCAI, and C. M. Heaney, RN, BSN, CCRC, CIP