In March and April 2020, the Food and Drug Administration (FDA) issued guidance aimed at expanding the availability of certain medical devices that were critical in fighting COVID-19, such as ventilators, respiratory devices, sterilizers, disinfectants devices, air purifiers, gowns, hoods, and gloves. The guidance, which would remain in effect only for the duration of the pandemic public health... Read More

Due to the limitations inflicted by the pandemic, Remote Interactive Evaluations (RIEs) are becoming an important part of regulatory decision-making. Specifically, the FDA is using RIEs to limit unnecessary contact.   Read More

How much does quality cost your company?  Read More

Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspections. The agency is now taking advantage of the available technologies to maintain high-level regulatory oversight remotely.  Read More

The medical device industry is already feeling the effects of the Artificial Intelligence (AI) revolution. However, most advanced AI algorithms are not well-suited for the current regulatory landscape. Fortunately, the FDA has released an action plan on how they plan to handle the challenges brought on by AI/ML-based software for medical devices.  Read More

When contracting with external experts, you may be uncertain about whether to select a consulting firm or work with an individual consultant, i.e. a single-person LLC or sole proprietorship.  Read More

When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improve the time-to-market for your product.   Read More

Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS.  Read More

Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes changes to the labeling for a medical device, they must assess the impact of the change against their 510(k) clearance.  Some changes may require a new 510(k) submission.  Others don't require a new 510(k) submission but will require thorough documentation of the changes.   Read More

In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and preventative actions have not been [adequately] established." (1)  Read More