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  • Regulatory NewsRegulatory News

    CDRH official offers advice for smoother Q-submission meetings

    A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...
  • Regulatory NewsRegulatory News

    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
  • Regulatory NewsRegulatory News

    FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

    The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...
  • 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...