USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those...

USA – Pandemic prompts mask, ventilator EUAs from FDA

This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use...

USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process

The US FDA’s Office of Combination Products (OCP) announced a pilot program in the Federal Register to help the OCP evaluate a potential new electronic submissions process for...

USA – FDA Purple Book Database now includes all CBER-, CDER-licensed biological products

The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for...

USA – FDA authorizes first two semi-quantitative COVID-19 serology tests

The US Food and Drug Administration has authorized the first two serology tests that report semi-quantitative data about past infection with SARS-CoV-2, the virus...

USA – Lawmakers introduce EtO monitoring bill

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from...

USA – FDA clarifies pooled sample, multi-analyte coronavirus EUAs

Developers of multi-analyte respiratory panels that include a test for SARS-CoV-2, the novel coronavirus, can request emergency use authorizations (EUAs) from the US Food...
New guidance on biologics affects authorized generics

USA – Multiple Function Device Products: Policy and Considerations

Medical products may contain several functions, some of which are subject to FDA's regulatory oversight as medical devices, while others are not. Section 3060(a)...
Access our Canada medical device regulatory chart in RAMS

Canada – Regulatory considerations on the classification of non-medical masks or face coverings

About non-medical masks or face coverings Non-medical masks or face coverings may help reduce the spread of respiratory droplets from the user to others or...

USA – FDA exempts additional Class II devices from 510(k) requirements

The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements,...

NOS PROCHAINES FORMATIONS