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 emergency, gave manufacturers regulatory flexibility for products that had already been submitted by a 510(k) premarket notification. The FDA emphasized that it would not object to certain modifications to devices or their indications of use.  

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.