What Do FDA Investigators Look for During an Inspection?
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
Our content and conferences are stronger than ever, and our new name, MedTech Intelligence, reflects a continued commitment to the medical device industry.
Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
Differing approaches to risk could hamper further growth of combination products.
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.