US FDA Clarifies Human Subject Requirements for Clinical Investigations

USA – US FDA Clarifies Human Subject Requirements for Clinical Investigations

EMERGO SUMMARY OF KEY POINTS: New US FDA guidance clarifies compliance requirements for clinical trial sponsors, investigators and IRBs whose studies fall under both...
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...
CDRH Drafts New Framework to Create a Pediatric Device Safety Network

USA – CDRH Drafts New Framework to Create a Pediatric Device Safety Network

A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical...
Combo Product Reviews: FDA Drafts Guidance

USA – Combo Product Reviews: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how...
FDA Expands RWE Demonstration Project

USA – US FDA Launches Pilot to Expand Special 510(k) Market Pathway

EMERGO SUMMARY OF KEY POINTS: US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices. Pilot would allow more...
FDA to End Alternative Summary Reporting for Devices

USA – CDRH Draft Guidance Tackles Nitinol Devices

As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed...
FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’...

A recent US Food and Drug Administration (FDA) notice proposed reverting to a 7-day grace period to review, edit and correct records that medical...
UK's NICE recommends Procept's robotic system for BPH

UK – UK’s NICE recommends Procept’s robotic system for BPH

Procept BioRobotics said today that it won an Interventional Procedure Guidance recommendation from the UK’s National Institute for Health and Clinical Excellence for is Aquablation...
FDA’s OCP Works to Modernize Review Functions

USA – FDA’s OCP Works to Modernize Review Functions

Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP)...
New Hip Replacement Procedure Launches

USA – New Hip Replacement Procedure Launches

The first two total hip replacement surgeries using a new 3D technology were recently performed by Gregory Martin, MD, founder of Personalized Orthopedics of...

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