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.  

How much does quality cost your company? 

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. 

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. 

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. 

To attract and retain top talent and keep your employees content, healthy company culture is crucial. Great company culture can boost certain metrics such as engagement, while also improving the workforce through activities such as individual recognition and team building. If you can create a culture that values your employees and leads them to value their employment in return, both your employees and your business will be able to thrive.  

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.  

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. 

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.  

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)