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...
Considering Old and New 510(k) Predicates

USA – Considering Old and New 510(k) Predicates

The 510(k) route to market for Class II devices involves the comparison of the candidate device to a legally marketable (already cleared) device. Note...
CDRH Drafts Guidance on Mouse Embryo Assays

USA – CDRH Drafts Guidance on Mouse Embryo Assays

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid...
FDA Approves First Generic Versions of EpiPen

USA – FDA Approves First Generic Versions of EpiPen

The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency...
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 Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

USA – US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

US FDA finalizes Safety and Performance 510(k) registration route; Performance criteria to play greater role in substantial equivalence for qualifying devices; 510(k) predicate...
Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

Boston Scientific won FDA regulatory approval to introduce the Eluvia drug-eluting vascular stent to the U.S. market. The device is the first peripheral stent to...
CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – CDRH Redrafts Policies on CLIA Waivers for IVDs

The US Food and Drug Administration (FDA) reissued two draft guidances on Wednesday to help in vitro diagnostic (IVD) manufacturers apply for and obtain...
FDA permits marketing of first medical device for treatment of ADHD

USA – FDA permits marketing of first medical device for treatment of ADHD

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device,...
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...

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