Advisories archive


FDA issues guidance on exempting certain medical devices from 510(k) requirements

USA: The US Food & Drug Administration (FDA) has issued guidance describing the intent to exempt certain...
February 11, 2019

FDA suggests improvements to De Novo pathway for novel medical devices

USA: The Food & Drug Administration (FDA) has published the De Novo Classification Proposed Rule, which proposes...
January 31, 2019

2018 US Farm Bill includes plant biostimulant definition

USA: The Agriculture Improvement Act of 2018 was signed into law on December 20, 2018 and provides the first statutory...
December 21, 2018

Notification of hazardous mixtures in France – Deadline 1 January 2019

Chemical product manufacturers, importers or distributors placing products on the French market are required to notify...
November 05, 2018

FDA releases updated cybersecurity guidance for medical devices

On 18 October, 2018, the US Food & Drug Administration (FDA) released a draft revision to its 2014 cybersecurity...
October 23, 2018