CDRH Steps Into the Social Media Realm

The U.S. Food and Drug Administration (FDA) has become much more social lately.

In an effort to enhance public communication and transparency, the FDA’s Center for Devices and Radiological Health (CDRH) has launched a Twitter account, its second in eight months. FDADeviceInfo focuses on safety issues such as device recalls and provides information on device approvals and radiation-emitting products. One of its inaugural posts on May 12 informed followers of a public meeting on infusion pumps (which took place May 25 and 26) in Silver Spring, Md. It gave an overview of the topics slated for discussion as well as a meeting agenda.

A later message, posted on May 20, provided followers with information about the FDA’s approval of the Alair Bronchial Thermoplasty System, a product designed to reduce the number of severe asthma attacks. In that Twitter message, the CDRH provided a link to the FDA’s approval letter, information about the company that makes the device (as well as a photo of the product), an explanation of how the system works, and medical conditions under which it should not be used.

With FDADeviceInfo, the CDRH now has more than 2,200 Twitter followers between its two accounts (403 for FDADeviceInfo and 1,873 for FDAcdrhIndustry). The agency started its first account, FDAcdrhIndustry, last September to discuss general issues in the device industry. Some of the latest Twitter messages discuss indoor tanning and tanning beds.

In addition to the pair of Twitter accounts, the CDRH has a Transparency Web site that provides information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions. The site (http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/default.htm) is part of the CDRH’s transparency initiative.

“The Center for Devices and Radiological Health Transparency Web site give the public a window into our work,” CDRH Director Jeffrey Shuren, M.D., said when the site was unveiled in April. “It provides a closer and clearer look at what we do and why we do it.”

The site includes information related to the following topics:

•Premarket submissions for approved and cleared products: Summaries of the FDA’s review 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 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 ways the FDA monitors medical device safety;
•Compliance and enforcement: Official actions the FDA has taken regarding problems with devices or device companies;
•Science and research: Research programs at CDRH or sponsored by CDRH;
•Educational resources: Information to help industry and others understand CDRH requirements and processes; and
•CDRH performance data: Metrics about CDRH programs.

The site also features a searchable Total Product Life Cycle database, which integrates premarket and postmarket medical device information from multiple data sources into a single snapshot.

FDA officials hope to expand the Web site to include premarket approval and clearance reviews. The site includes a feedback feature that allows FDA to collect input and suggestions from the public about the information provided.

“The Web site launch is only a beginning for transparency efforts within the Center for Devices and Radiological Health,” Shuren said.