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Patricia O'Connell
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Sonali Gunawardhana Discusses FDA's Efforts to Standardize Medical Device Labels

Bloomberg BNA 
April 15, 2015

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted in a recent Bloomberg BNA article about the U.S. Food and Drug Administration’s (FDA) efforts to standardize the labeling of medical devices. The FDA plans to study how doctors and other professionals respond to standardized labeling in comparison to existing device labeling, according to the article.

Ms. Gunawardhana said the FDA Center for Devices and Radiological Health’s (CDRH) 2013 strategic priorities included taking steps to improve the accessibility of device labeling so that consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices in order to use this information to make health care decisions. She also noted that the effort to standardize device labels follows a 2013 FDA rule requiring unique device identifiers.

CDRH already has a standardized label regime in place for in vitro diagnostics as demonstrated by the issuance of a 2004 guidance document on the topic, Ms. Gunawardhana told BNA’s Medical Devices Law & Industry Report.