FDA Launches the TEMPO Pilot for Digital Health Devices

By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte

The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.

Read the full Alert on the Duane Morris LLP website.

INFORM Consumer Act Designed to Curb Counterfeits

In March 2021, the Senate reintroduced a revised version of a bill calling for online retailers to publish specific, verified information concerning high-volume third-party sellers of consumer products for their customers. The Integrity, Notification and Fairness in Online Retail Marketplaces (INFORM) for Consumers Act is directed toward putting an end to the online sale of stolen, counterfeit and unsafe consumer products.

In particular, online marketplaces that include high-volume third-party sellers would be required to authenticate vendors’ identities through essential identification and contact information in the hopes of preventing not only anonymous online sales of counterfeit goods, but also preventing organized retail crime rings from stealing from stores and reselling items online.

To read the full text of this Duane Morris Alert, please visit the firm website.

Nanette Heide Comments on the Future of Private Equity Firms and Small Beauty Brands

Nanette Heide, Duane Morris partner and Fashion/Retail/Consumer Branded Products Group senior advisory partner, is quoted in Glossy article, “Private Equity Firms Will Get Comfortable With Small Beauty Brands in 2020.”

“The trend will be private equity companies getting involved in brands earlier and taking on a minority stake versus majority control,” she said. “They’ll blur the lines of venture capital in order to make sure they are in early enough, because then brands can catch fire and sell within 16 months.”

To read the full article, visit the Glossy website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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