An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
What are the challenges faced by OCP?
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
Differing approaches to risk could hamper further growth of combination products.
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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.