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  • Feature ArticlesFeature Articles

    FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

    This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the ...
  • Feature ArticlesFeature Articles

    Contingency Plans for MDR and IVDR Implementation for a no Deal Brexit

    This article discusses implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) regarding the potential exit (called Brexit) of the United Kingdom (UK) from the European Union (EU). The author suggests the fate of regulations will be not without consequence should the UK and the remaining members of the EU find they are unable to negotiate how medical devices will be regulated, sold and moved between the UK and t...
  • Feature ArticlesFeature Articles

    FDA Announces new TRG Rapid Inquiry Program

    This article discusses the US Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG) new Rapid Inquiry Program (TRIP). 1 The author covers how the TRIP program is designed to work and explains elements of its regulatory changes under the Code of Federal Regulations, Title 21 Part 1271: human cells, tissues and cellular and tissue-based products (HCT/Ps). She describes product registration requirements and exceptions and highlights the program’s multiple benef...