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 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...
Biosimilar use may increase with scrutiny of high drug prices

USA – US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

EMERGO SUMMARY OF KEY POINTS: US FDA has provided more information on its upcoming Accreditation Scheme for Conformity Assessment (ASCA) pilot program. ASCA will...
Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

Sometimes even seemingly good ideas just don't pan out. Read on to see seven medtech products that once held a lot of promise but just...
FDA Removes 9% of Medical Device Registrations from Database

USA – FDA Issues New Classification for Implantable Bone Conduction Hearing System

Upon request, FDA has classified the active implantable bone conduction hearing system as class II (special controls), which we have determined will provide a...
CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

USA – CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a...
First Version of NEST to Launch in 2019

USA – First Version of NEST to Launch in 2019

The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health...
US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations

USA – US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations

EMERGO SUMMARY OF KEY POINTS: US FDA updates cybersecurity guidance first issued in 2014 for medical device premarket submissions. The new guidance introduces a...
Device Firms to Inform New FDA Framework on Servicing

USA – Device Firms to Inform New FDA Framework on Servicing

Following a decision against extending regulatory requirements to third-party device servicers, the US Food and Drug Administration (FDA) is seeking feedback to inform upcoming...
UDI: 5 Opportunities You May Not Have Considered

USA – UDI: 5 Opportunities You May Not Have Considered

It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an...

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