FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Medical Devices, FDA, Uncategorized / Stephen D. Terman

The U.S. Food and Drug Administration (FDA) has been actively working to address cybersecurity concerns related to medical devices. On March 29, 2023, FDA published a much-anticipated cybersecurity final guidance regarding cybersecurity requirements for medical device pre-market submissions. Medical devices, like many other modern technologies, are susceptible to cybersecurity vulnerabilities that could potentially compromise patient […]

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OFW Law Launches FDA DevicEd Training Initiative

FDA, OFW Law News / Stephen D. Terman

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative. The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them. Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of

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My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

FDA / Stephen D. Terman

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document lifted much of the regulatory uncertainty regarding which types of mobile apps FDA would and would not be actively regulating. Some of the regulated MMAs are developed (i.e., manufactured) by entities that have little to

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Stephen D. Terman

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

OFW Law Launches FDA DevicEd Training Initiative

My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

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