Product Liability Update - November 2013


Summary of FDA Guidance on Mobile Medical Apps

by Daniel Wittenberg and Andrea Fitzgerald

On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps will be regulated by the FDA and who will be required to comply with the regulations. The FDA intends to focus its oversight on mobile medical apps whose functionality poses a risk to patient safety if the mobile app malfunctions.

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Newest Food Safety Rules Approach Deadline

by Joseph S. Kiefer

In June, a federal judge in California ordered the U.S. Food and Drug Administration (“FDA”) to issue proposed rules for the Food Safety Modernization Act (“FSMA”) by November 30, 2013. In July, the agency requested an extension for two of five rules that must be proposed by the November deadline. One of the primary areas at issue is known as the “intentional adulteration” or “anti-terrorism” rule related to contamination of food primarily from foreign markets. The agency requested an additional two years to develop this rule, indicating it had not previously regulated in this area.

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Four New Privacy Laws and What They Mean for Businesses

by Kelly MacHenry

Does your business operate a website, online service, application or database? California has passed a group of privacy and data security laws that apply to those types of businesses. The new laws are either effective already or will be soon. Because most websites, applications and databases involve California residents, such new laws effectively set a nationwide baseline.

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