• Regulatory NewsRegulatory News

    FDA proposes breakthrough status for devices that address health disparities

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.   These updates were proposed in a recent draft guidance issued on Thursday. If ...
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    FDA finalizes guidances on device post-approval studies, postmarket surveillance

    The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and to better understand the agency’s expectations for conducting post-approval studies of these products.   The final versions contain minor changes from the draft versions released for comment in May 2021. (RELATED: FDA issues new draft guidances on devi...
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    CHMP recommends 12 new medicines, including first RSV treatment for infants

    The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.   The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was s...
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    FDA officials discuss prioritizing inspections, QMSR transition

    Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...
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    FDA warns that some prenatal screening tests can generate false results

    Some non-invasive prenatal tests  (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic purposes, the US Food and Drug Administration (FDA)  warned on Tuesday.   The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.   These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are ...
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    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
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    Device companies urge FDA to refine guidance on PCLC devices

    Medical devices companies urged the US Food and Drug Administration (FDA) to expand the scope of its recent guidance on assessing physiologic closed-loop control (PCLC) technology to cover non-invasive devices and to incorporate additional standards when outlining patient hazards.   Other companies suggested that FDA include additional examples of sensor performance risks.   The comments were in response to FDA’s draft guidance for manufacturers on developing med...
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    FDA Approvals Roundup: Vabysmo, Cabenuva, Vonvendi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vabysmo approved for treating two types of macular disease Genentech’s Vabysmo ( faricimab-svoa; injection ) has been approved for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. The bispecific antibody targets and inhibits the disease pathways in the respective conditions.   Approval of Vabysmo...
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    FDA: Device breakthrough program surpassed expectations, while novel device authorizations fell in 2021

    In its 2021 annual report, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said that it cleared, approved or authorized a record 13 devices with breakthrough status, though the number of novel devices it authorized fell from its peak last year.   The report also discusses the center’s actions to address device shortages, thanks to new funding from Congress, as well as its COVID-19 pandemic response, patient engagement and d...
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    FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...
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    FDA issues draft guidance on assessing physiologic closed-loop control devices

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with physiologic closed-loop control (PCLC) technology to ensure their safe and effective use. Submissions should carefully weigh patient and device-related risks as well as use-related hazards.   These devices consist of a sensor that measures a physiologic variable from the patient, a controller/control...
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    FDA expands eSTAR filing to de novo devices, IVDs

    US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in 2020 began with a template for 510(k) device submissions.   Nine companies participated in that pilot program that trialed the interactive, PDF-based filing format. Use of eSTAR was expanded in September 2020 to include all 5...