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.
When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
For 3D printing to thrive in the medical device space, the use of biomaterials must be expanded.
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.