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09 December 2019
Despite concerns raised by both the medical device industry and EU member states that the 26 May 2020 deadline for the Medical Devices Regulation (MDR) is unfeasible, European commissioner for health Stella Kyriakides said Monday that the EC is fu...

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09 December 2019
In a letter to Acting US Food and Drug Administration (FDA) Commissioner Brett Giroir last week, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) raised questions about the agency’s plans to issue rules to regulate over-the-counter (OTC)...
09 December 2019
The US Food and Drug Administration (FDA) last week warned two California-based companies, Liveyon Labs Inc. and Liveyon LLC, for processing and distributing unapproved umbilical cord blood stem cell products.
09 December 2019
Whether the US Food and Drug Administration (FDA) classifies a product as a drug or a device can have huge implications for the sponsor, partly because of how the agency reviews the different products and partly because of the increased cost of br...
09 December 2019
The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009.
06 December 2019
Regulators including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are looking into whether formulations of the diabetes drug metfo...
06 December 2019
The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance (MR) coils under the agency’s safety...