Canada – Guidance on summary reports and issue-related analyses for medical devices: Overview

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – HHS pushes through last-minute policies impacting FDA

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that...
New guidance on biologics affects authorized generics

USA – FDA lays out 2021 regulatory science areas of focus

Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to...

USA – FDA: COVID-19 variants may affect molecular test results

The U.S. drugs regulator said on Friday genetic variants of COVID-19, including the one found in the UK, could lead to false negative results...

USA – US FDA provides extra response time for device submissions on hold and...

In June 2020, the US Food and Drug Administration (FDA) published a guidance document outlining the impact of the COVID-19 pandemic on meetings and user fee applications for...

USA – Guidance : Safer Technologies Program for Medical Devices

The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety...

Canada – Importation and sale of medical devices for COVID-19 guidance document

COVID-19 is the infectious disease caused by coronavirus, SARS-CoV-2. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11,...

Canada – New regulations strengthening the post-market surveillance and risk management of medical devices...

Changes to the regulations Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA extends timeline for device submissions on hold during pandemic

The US Food and Drug Administration (FDA) on Tuesday revised its guidance on meetings and user fee applications for medical devices during the COVID-19...

USA – FDA Approves Prosthetic Implant for Above-the-Knee Amputations

The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed...

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