USA – FDA outlines safety and performance-based criteria for facet screw systems and denture...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria...
U.S. FDA Approves TherapeuticsMD's Menopause Drug

USA – Vagal nerve stimulator for stroke rehab nabs FDA nod

The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent...

USA – FDA updates safety communication for robotically assisted surgical devices used in mastectomy

The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to...
Coronavirus delays many FDA foreign inspections

USA – FDA affirms increased risk with pelvic mesh products

The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant...

USA – Update: Check first with FDA regarding their current availability to review a...

In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors (HF) validation test protocols for...

USA – Update: FDA is not accepting human factors validation test protocols for review...

In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors validation test protocols for agency...

USA – Proposed US FDA program targets medical device supply chain shortages

A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but...
ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program

Brazil – Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers

Brazilian medical device market regulator ANVISA has rolled out its proposed framework for Unique Device Identification (UDI) requirements, and is seeking public comment on...

USA – CDRH official offers advice for smoother Q-submission meetings

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings,...
New guidance on biologics affects authorized generics

USA – FDA seeks expanded authority to boost device supply chain

FDA has called for new powers and more funding to improve its ability to prevent medical device shortages. Janet Woodcock, the acting FDA commissioner, said...

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