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...
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...
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...
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...
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...
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