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See today's BioWorld MedTech
Home » FDA enforcement discretion for digital health a source of uncertainty for industry
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FDLI Enforcement Conference

FDA enforcement discretion for digital health a source of uncertainty for industry

Dec. 28, 2020
By Mark McCarty
The U.S. FDA has exercised a considerable degree of enforcement discretion during the COVID-19 pandemic, particularly when it comes to digital health. However, Christine Bump, principal at Penn Avenue Law & Policy, said that this very discretion has an uncertain shelf life and advised industry to remain compliant with the regulations as much as possible to avoid unnecessary enforcement actions by federal agencies.
BioWorld MedTech Regulatory Digital health SAMD U.S. FDA

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