FDA Opens Office of Digital Transformation to Streamline Data and Cybersecurity Efforts
FDA formally opened the office as part of a broader effort to modernize and strengthen its information technology, data management,...
FDA formally opened the office as part of a broader effort to modernize and strengthen its information technology, data management,...
FDA doubled down on its enforcement commitment for Human Cell and Tissue Products after its enforcement discretion ended in May....
FDA recently announced its plans to resume inspections by July. The agency is working through a backlog of 8,000 inspections...
Orthopedics accounted for the largest portion of Class II recalls last year. FDA representatives and industry consultants recently detailed both...
Notified Bodies talk “significant change,” capacity and reporting requirements for orthopedic device companies....
Incorrect inventors could lead to patents being deemed invalid. Companies should follow best practices like creating a claim chart to...
Biocompatibility is a topic of growing interest for FDA. The goal of the resource center is to explain terms and...
While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could...
FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and...
FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and...
The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing...
Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future. ...
The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks...
Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice...
Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated...
Login to your Bonezone account to access favorite articles, saved suppliers, and more.
In less than a minute you'll have access to a customizable BONEZONE experience.
We’ll send a recovery link to your email.