Advisories

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 unclassified medical devices from 510(k) submission. The devices...

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 unclassified medical devices from 510(k) submission. The devices...

USA: The Food & Drug Administration (FDA) has published the De Novo Classification Proposed Rule, which proposes...
USA: The Agriculture Improvement Act of 2018 was signed into law on December 20, 2018 and provides the first statutory...
Chemical product manufacturers, importers or distributors placing products on the French market are required to notify...
On 18 October, 2018, the US Food & Drug Administration (FDA) released a draft revision to its 2014 cybersecurity...
In June, The European Chemicals Agency (ECHA) added 10 new substances of very high concern (SVHC) to the...
The European Commission had tasked ECHA and EFSA with developing harmonised guidance to ensure that the endocrine...
In August 2016 the Office of Environmental Health Hazard Assessment (OEHHA) adopted Article 6 Clear and Reasonable...
One of Health Canada’s responsibilities is the regulation and evaluation of health products prior to their...
The US Environmental Protection Agency (EPA) has released a “Quick Guide for Disinfectant Products for Drinking Water...
On August 11, 2017, the Federal Register published the Toxic Substances Control Act (TSCA) Inventory Notification Rule...
The conversation of cleaning product safety has been a growing concern for state officials across the country...
The California Department of Food and Agriculture (CDFA) is requesting public comments on the Requests for...
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