• Regulatory NewsRegulatory News

    House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests

    In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests. The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from  in ...
  • Feature ArticlesFeature Articles

    Types of In Vitro Diagnostics: Clearing Up the Confusion

    All in vitro diagnostics (IVDs) for human use are medical devices. After that, it is easy to get lost in a seemingly foreign language of acronyms—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? How does it even begin to know into which category its new device will fall? The US Food and Drug Administration (FDA) has several good guidance doc...
  • Feature ArticlesFeature Articles

    Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

    The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...