Steven Tjoe Steven Tjoe

Steven Tjoe is a FDA Senior Associate, FDA Counseling Group at Goodwin. Steven advises drug, biotech, medical device, and diagnostic developer clients on a range of FDA regulatory matters, including product development strategies, lifecycle management & competition issues, advertising & promotion issues, and regulatory compliance. Prior to joining Goodwin, Steven served as regulatory counsel at FDA’s Center for Devices and Radiological Health.

3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices

Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine ...

Steven Tjoe
Steven Tjoe

Promotion of Devices Subject to the FDA’s COVID-19 Enforcement Policies

On April 16, 2021, the FDA announced the withdrawal of their January 15, 2021 ...

Steven Tjoe
Steven Tjoe

Public Health Crises and FDA Scrutiny

Every public health emergency or outbreak brings with it a corresponding urgent need for ...

Julie Tibbets
Julie Tibbets
Steven Tjoe
Steven Tjoe

The FDA, Marketing Claims, and Digital Health Products

For both developers and marketers of digital health products, a thorough evaluation of each ...

Steven Tjoe
Steven Tjoe

Marketing Laboratory Developed Tests

On April 4, 2019, the U.S. Food and Drug Administration issued a Warning Letter ...

Steven Tjoe
Steven Tjoe
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