USA – AdvaMed Backs Wright Medical in Hip Liability Case
A case stemming from a hip implant lawsuit against Wright Medical has caught the attention of several professional associations, including AdvaMed, as the outcome could have...
Canada – Health Canada to Release Action Plan for Medical Devices Amid Reports of...
Following a first-of-its-kind investigation into serious patient injuries associated with use of implants, the Canadian Minster of Health called on Health Canada to issue...
USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says
The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report...
Canada – AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices
AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing...
USA – FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices
The US Food and Drug Administration (FDA) issued draft guidance Wednesday to update the current framework on acceptable levels of uncertainty in regulatory decision-making...
USA – FDA – MD Safety Action Plan to enhance post-market safety : Statement...
In April of this year, the FDA released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which described recent actions we’ve taken...
USA – CDRH Qualifies 3rd Medical Device Development Tool
A software module intended to aid health care providers in marking and classifying brain contusions became the third medical device development tool (MDDT) to...
Canada – Health Canada Developing MDL Policies for 3D-Printed Medical Devices
EMERGO SUMMARY OF KEY POINTS:
Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices.
The Draft guidance will cover Class...
USA – FDA Proposes Rule to Implement New De Novo Classification Process
The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying...
USA – FDA Withdraws Proposed Rule on Electronic Labeling for Certain Devices
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it was withdrawing a proposed rule that...
