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The US Food and Drug Administration (FDA) issued draft guidance Wednesday to update the current framework on acceptable levels of uncertainty in regulatory decision-making...
Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam

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...
CDRH to Survey Manufacturers in Prep for Device Shortages

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...
Health Canada Creates New Medical Devices Directorate

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 The Draft guidance will cover Class...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 Debates Creating Pilot to Evaluate Novel Excipientshangeability With a Reference Product

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 authorizes marketing of first diagnostic test for detecting Zika virus antibodies

USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
Examining US FDA criteria for medical device cybersecurity and risk management

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...
Wearable device studied for detection of pediatric anxiety, depression

USA – Wearable device studied for detection of pediatric anxiety, depression

When Ellen McGinnis started her career as a psychologist several years ago, she realized just how hard it can be to spot anxiety and...
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...
CDRH to Survey Manufacturers in Prep for Device Shortages

USA – CDRH Touts Uptick in Foreign Device Inspections

The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials...

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