Medical Devices

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Medical Devices, FDA, Uncategorized / Steve 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 […]

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management Read More »

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?

The de novo process employed by FDA’s Center for Devices and Radiological Health (CDRH) is a less frequently used mechanism for the clearance of medical devices. The de novo process employs a risk-based strategy for evaluating applications. It is used for new, novel devices that lack previous classification. These would ordinarily be Class III devices,

Medical Devices

FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?

FIRM

INDUSTRIES

Food & Agriculture

Customs and Trade

Consumer and Commercial Litigation

Cannabis

NEWSLETTER

Industries

Our Firm

Insights