AdvaMed Backs Wright Medical in Hip Liability Case

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...
Health Canada Details Medical Device Action Plan

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...
FDA isn't doing enough to prevent medical device hacking, HHS report says

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...
AdvaMed Calls for Revisions to Health Canada Guidance on 3D-Printed Implantable Devices

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AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

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The US Food and Drug Administration (FDA) issued draft guidance Wednesday to update the current framework on acceptable levels of uncertainty in regulatory decision-making...
FDA to Test PreCert De Novo Requests Under Pilot

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...
Bipartisan Bill would allow Drug Imports from Canada

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 The Draft guidance will cover Class...
FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections

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...
FDA to beef up cell and gene therapy staff

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...
FDA Reveals Vision for the Transition to ISO 13485

USA – FDA Reveals Vision for the Transition to ISO 13485

An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug...

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