• Regulatory NewsRegulatory News

    FDA, Industry See Progress in MDUFA IV Negotiations

    At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction. The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the ef...
  • Regulatory NewsRegulatory News

    Top Legal Minds Against FDA's Proposal to Regulate Lab Tests

    A new legal whitepaper authored by two of America's most prominent lawyers argues that the US Food and Drug Administration's (FDA) plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful. For more on LDTs and why and how FDA wants to regulate them, please see our August 2014 explanation of the policy shift here. The legal analysis is co-authored by  Paul Clement, the former US ...
  • Regulatory NewsRegulatory News

    In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

    The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...
  • Citizen Petition Claims Lab-Developed Tests aren't Devices and are Beyond FDA Regulation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of diagnostic devices known as laboratory-developed tests (LDTS), but now at least one association has filed a Citizen Petition with the agency seeking to exempt LDTs from new guidance, new regulation or seemingly any regulation whatsoever. Background Under normal circumstances, med...