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  • Regulatory NewsRegulatory News

    CDRH Redrafts Policies on CLIA Waivers for IVDs

    The US Food and Drug Administration (FDA) reissued two draft guidances on Wednesday to help in vitro diagnostic (IVD) manufacturers apply for and obtain Clinical Laboratory Improvement Amendments (CLIA) waivers. The newly drafted guidance documents—first issued last November—were updated to reflect input from the comment period that closed after an extension granted per the request of the Coalition for CLIA Waiver Reform earlier this year. Modifications to the 2017...
  • Regulatory NewsRegulatory News

    FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

    The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). Under CLIA, clinical laboratories must obtain a certificate to perform complex diagnostic t...
  • Regulatory NewsRegulatory News

    CLIA Waiver Decisions: FDA Begins Posting Summaries

    The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency. FDA also updated its guidance on its administrative procedures for CLIA categorization for IVDs to reflect new commitments under the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). So far, the agency has posted de...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • Regulatory NewsRegulatory News

    FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

    The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...
  • Regulatory NewsRegulatory News

    FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

    • 20 April 2015
    • By
    The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies. Background The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests devel...
  • 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...
  • Regulatory NewsRegulatory News

    How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

    The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
  • 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...
  • New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs

    A new final guidance document released by US medical device regulators makes recommendations on how to comply with the Clinical Laboratory Improvements Amendments (CLIA) , a 1988 law that instituted laboratory testing requirements meant to improve in vitro diagnostic testing. The guidance, Administrative Procedures for CLIA Categorization , was released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on 11 March 2014. ...
  • 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...