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    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   These updates were proposed in a recent draft guidance issued on Thursday.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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    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: 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 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...
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    FDA announces stronger warnings on breast implant labels

    The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.   FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patien...
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    FDA issues proposed OTC hearing aid rule

    The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.   Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . The act directed FDA to create a report available f...
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    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...