De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low ...

Researchers identified the most effective screening tools and treatment options for children with obsessive compulsive ...

Although the insertion of inferior vena cava filters declined between 2013 and 2021, the rate of retrievals remained low, ...

Non-EU vendors are required to designate an EU-based authorized representative, so ask for proof during your evaluation. If your potential partner isn’t EU-based, dig deeper. Do they have a ...

Complete and submit an online application. Applicants can monitor the status of their application in the online application system to see when all components have been received. Transcripts uploaded ...

In the pre-procedure evaluation everything seemed to be normal,' Matos said. 'But in any surgical intervention, there are repercussions that can be immediate or delayed.' Amezquita told the outlet ...