FDA Wants to Take a Hard Look at Medical Device Materials

USA – FDA Wants to Take a Hard Look at Medical Device Materials

As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.  The agency released a statement Friday from...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

Canada – Health Canada: MDSAP Could Force Some Manufacturers Out

With the approaching deadline for those in Canada to comply with the Medical Device Single Audit Program (MDSAP), Health Canada issued a notice to...
Benefits of ERP in an FDA-Regulated Environment

USA – Benefits of ERP in an FDA-Regulated Environment

This guide will examine how medical device manufacturers are increasingly turning to ERP systems to mitigate compliance risk and turn developmental concepts into commercialize...
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...
Biosimilars Forum Calls for FDA Guidance to Address Misinformation

USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued two final orders on Wednesday, classifying the...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – Device makers seek transparency on Breakthrough Devices Program

A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority...
Biosimilar use may increase with scrutiny of high drug prices

USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity. ...
Does More FDA Oversight Equal Better Compliance?

USA – Does More FDA Oversight Equal Better Compliance?

Since 2007, FDA has increased its annual number of medical device inspections by 46% and has increased annual inspections of foreign firms by 243%....
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – CDRH to Review Materials Used in Medical Devices

Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb...
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

USA – FDA Warns of Cyber Vulnerability in Medtronic Implantable Cardiac Devices

The US Food and Drug Administration (FDA) on Thursday issued a safety communication to alert of cybersecurity vulnerabilities for Medtronic cardiac implantable electrophysiology devices...

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