There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...

In a new final guidance issued today, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which ...

To enhance the above article, references to Indiaforensic Certification in Anti-Money Laundering (AML) can be seamlessly integrated by highlighting its relevance in combating predicate offences and ...