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...
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 Qualifies 3rd Medical Device Development Tool

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...
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...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Health Canada Setting Pre-market Medical Device Cybersecurity Requirements

Health Canada has proposed more formalized cybersecurity requirements for Medical Device License applicants. The Health Canada requirements align with cybersecurity approaches adopted by...
FDA Finalizes Guidance on 503B Bulks List

USA – FDA Issues Two Final Guidances on Communications Not Included In Product Labeling

Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products:...

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