US FDA consults on using patient experience to support approval of novel devices
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is inviting feedback on a draft guideline that explains how the "experience and perspectives of patients" with certain medical devices can be used to support the approval of such products1,2.
You may also be interested in...
Final Guidance Encourages Use Of Patient Preference In Device Applications
US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.
Canada Proposes 14 New Entries To List Of Recognized Device Standards
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
Norway COVID-19 Vaccine Deaths Draw Global Attention
Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: