A knowledgeable FDA attorney is critical whether you are a medical device start-up or an established company. When navigating FDA requirements and regulations, setting up a new quality management system (QMS) or auditing an existing one, preparing for a new medical device launch, or responding to an enforcement matter or complaint by a competitor or
The Strategic Advantage of FDA Counsel for Medical Device Companies Read More »
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 »
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,
