FDA Releases Computational Modeling and Simulation Guidance
FDA's guidance focuses on the credibility of CM&S in medical device submissions....
Jan 10 2022,
Regulations
FDA Releases Potential Framework for Point-of-Care 3D Printing
FDA's discussion paper outlines scenarios in which hospitals might 3D-print devices and asks industry for comments. ...
Dec 15 2021,
Development and Lifecycle Management of Software as a Medical Device
Orthopedic companies that manufacture medical software products are required to manage the life cycle of their medical device software....
Oct 29 2021,
Defining and Regulating the Complex World of Software as a Medical Device
Global regulators are considering how to adapt to the fast-moving nature of software as a medical device technology. ...
Oct 11 2021,
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,...
Sep 20 2021,
New Warning from FDA: Sales of Unapproved Orthobiologic Products
FDA doubled down on its enforcement commitment for Human Cell and Tissue Products after its enforcement discretion ended in May....
Jun 22 2021,
FDA Details Plan to Restart Facility Inspections
FDA recently announced its plans to resume inspections by July. The agency is working through a backlog of 8,000 inspections...
May 25 2021,
FDA Update: State of Recalls and Risk Analysis
Orthopedics accounted for the largest portion of Class II recalls last year. FDA representatives and industry consultants recently detailed both...
May 10 2021,
What’s on the Minds of Notified Bodies as EU MDR Deadline Approaches?
Notified Bodies talk “significant change,” capacity and reporting requirements for orthopedic device companies....
May 10 2021,
Virtual Product Development Brainstorming Sessions and Patent Inventorship Issues
Incorrect inventors could lead to patents being deemed invalid. Companies should follow best practices like creating a claim chart to...
Apr 16 2021,
FDA Strengthens its Biocompatibility Focus with new Resource Center
Biocompatibility is a topic of growing interest for FDA. The goal of the resource center is to explain terms and...
Mar 30 2021,
EU Allows Notified Bodies to Conduct Audits Remotely
While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could...
Jan 26 2021,
FDA Releases AI Action Plan for Medical Devices
FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and...
Jan 25 2021,
Additive, AI, Digital Health Noted in FDA’s 2021 Science Report
FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and...
Jan 12 2021,
FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway
The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing...
Jan 11 2021,