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

USA – FDA permits marketing of first medical device for relief of pain associated...

The U.S. Food and Drug Administration today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA issues new draft guidances on device postmarket surveillance

The US Food and Drug Administration (FDA) has issued two draft guidances to help device manufacturers comply with postmarket surveillance requirements and to understand...
European Regulators Publish UDI Guidance |

USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by...

he US Food and Drug Administration (FDA) released new guidance Friday that effectively pushes back by two years the date by which FDA will...
Determining Whether to Submit an ANDA or a 505(b)(2) Application - Guidance for Industry

USA – Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19)...

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious...

USA – COVID-19 pauses US FDA inspection plans, again

Due to the coronavirus pandemic, the US Food and Drug Administration (FDA) has further delayed inspection plans, at least until  February 4, 2022. The regulator had...
Biological medicine quality to receive major boost

UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – ANVISA publishes list of exempted healthcare products and cybersecurity guide

Brazil’s National Health Surveillance Agency (ANVISA) has issued an up-to-date list of healthcare products exempt from regulation and a new cybersecurity guide for medical...

USA – FDA recommends sponsors plan to include race, ethnicity in clinical trial design

The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products...
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...

Canada – Medical Devices Action Plan: Progress report

We launched the MDAP in December 2018. Since its publication, we have made significant progress toward achieving the goals of the action plan's 3...

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