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,
Regulations
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,
Clinical Trials Shift to Hybrid Approaches in the Age of COVID-19 and Beyond
Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future. ...
Nov 24 2020,
How to Take a Risk-Based Approach to Biocompatibility
The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks...
Nov 16 2020,
MDR Experts Share How to Successfully Navigate the Requirements
Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice...
Oct 30 2020,
Considerations for Your Device’s Manual and Mechanical Cleaning Validations
Proper cleaning protocols for reusable medical devices have become a major focus in light of the recent superbug outbreaks associated...
Sep 30 2020,
4 Human Factors Practices that Lead to Successful FDA Submission
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not...
Sep 22 2020,
FDA Update: Inspections Return, De Novo Classification and ISO 13485 Added to Agenda
FDA has made multiple announcements in recent weeks, including the return of domestic inspections as well as decisions on De...
Jul 21 2020,
FDA Repeats Call for Advanced Manufacturing Efforts
FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC...
Jul 08 2020,