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Patricia O'Connell
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Sonali Gunawardhana Quoted in Bloomberg BNA Article on Medical Devices

Bloomberg BNA
March 6, 2014

Sonali Gunawardhana, of counsel in Wiley Rein's Food & Drug Law Practice, recently spoke at the Food and Drug Law Institute's 2014 Medical Device Federal Regulation and Enforcement Conference. Some of Ms. Gunawardhana's remarks were quoted in a Bloomberg BNA article published March 5.

The article focused on how the reorganization of the compliance office within the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last year could lead to increased enforcement activity especially in the area of promotion and advertising. The violation most frequently noted during inspections by the CDRH was with respect to "quality system issues," these design failures resulted in approximately half of all recalls in 2013. On its website, the FDA said it is working with the device industry, health care providers, patients, payers, and investors to encourage a new focus on implementing quality at all stages of medical device development.

These quality issues affect the entire industry, as they "can impair or enhance the overall market reputation," Ms. Gunawardhana -- a former top FDA attorney -- said during the conference.