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...
Access our Canada medical device regulatory chart in RAMS

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...
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

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and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid...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 Drafts Guidance on Restricted Delivery Systems for Liquid Drugs

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:...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the...
Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

USA – Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

he US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP)...
New guidance on biologics affects authorized generics

USA – Has FDA relaxed its human factors expectations in response to the COVID-19...

There are several key activities required by the US Federal Drug Administration (FDA) to meet its expectations for the application of human factors (HF)...
Eximo Medical’s Atherectomy Laser Cleared by FDA

USA – Eximo Medical’s Atherectomy Laser Cleared by FDA

The FDA granted 510(k) clearance for Eximo Medical’s B-Laser atherectomy system, used for treating patients with peripheral artery disease, including in-stent restenosis. The device —...
FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

USA – FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test...
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,...

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