Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements. The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. But for four of the five product codes proposed on Thursday, FDA has ...

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price appro...

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...