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 to End Alternative Summary Reporting for Devices

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...
Drugmakers, EMA Comment on FDA Guidance on Assessing Food Effects on Drugs

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...
FDA Proposes New Framework on Prescription Drug-Related Software

USA – FDA Proposes New Framework on Prescription Drug-Related Software

The US Food and Drug Administration (FDA) issued a request for comment on Monday that sets forth a proposal for a new framework on...
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...
Framework for the Regulation of Regenerative Medicine Products

USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid...
FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the...
TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

USA – UL Wades into Cybersecurity of Connected Medical Devices

Safety science firm UL is honing in on the cybersecurity of connected medical devices, suggesting a two-pronged approach that spans across the total product...
US FDA Updates UDI Policy for Direct Marking of Medical Devices

USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices

EMERGO SUMMARY OF KEY POINTS: US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices. ...
Wearable dialysis system gains breakthrough designation from FDA

USA – FDA permits marketing of two devices that detect parathyroid tissue in real-time...

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as...

NOS PROCHAINES FORMATIONS