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  • Regulatory NewsRegulatory News

    FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

    While seeking to safeguard its gold standard for approvals, the US Food and Drug Administration (FDA) is modernizing its 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissi...
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    CDRH Clarifies What Success Means for Special 510(k) Pilot

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) clarified on Thursday how the center intends to assess the success of its new special 510(k) program pilot based on the types of information to be collected.   Last month, CDRH issued draft guidance to propose certain modifications to the existing special 510(k) program aimed at expanding device eligibility criteria and subsequently launched a new pilot to ope...
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    CDRH Finalizes Classifications on Anesthesiology, ENT Medical Devices

    The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued two final orders Thursday, classifying an anesthesiology and an ENT device into class II.   The classifications complete the work on the de novo classification requests submitted to CDRH in early 2017. Vapotherm’s de novo request for the classification of the Precision Flow HVNI, which is designed to help patients breathe easily, was granted in April. The de novo request for ...
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    CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

    The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine individual premarket testing recommendations for ophthalmic optical coherence tomography (OCT) devices.   Under the pilot program, the individual premarket testing recommendations CDRH staff will seek to refine in collaboration with participating manufacturers are aimed at enabling greater consistency in 510(k) s...
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    CDRH Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
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    CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

    In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).   The two devices are named “herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel” and “external upper limb tremor stimulator.”   Both of the new de novo classifications are intended to “enhance patients’ access to beneficial innovative devices, in part by reduci...
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    CDRH Requests Labeling Changes on Certain Pen Needles

    In a letter to manufacturers of pen needles designed to be used with injectors, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) called for labeling updates to address the adverse events associated with improper patient use.   The request comes after the agency became aware of the reported incidents of hyperglycemia, diabetic ketoacidosis and at least one patient death through medical device reports and FDA’s adverse ev...
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    Special 510(k)s: FDA Seeks Input to Expand Eligibility

    Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program.   The 32-page draft guidance for industry and FDA staff is intended to update the policies set forth when the program was launched in 1998. At the time, modifications to the intended use of a device or any labeling changes were deemed inappropriate for special 510(k) submissions.   “We are proposing to evaluate whether design a...
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    FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

    After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices. FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act...
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    What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

    While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence. The creation of this voluntary, alternative 510(k) pathway, first announced back in September , "will allow more flexibility to use more moder...
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    When to Submit a New 510(k): FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software. In August 2016, FDA released the two draft guidances, five years after the agency's first attempt to replace its 1997 guidance on 510(k) changes. But the agency withdrew the 2011 draft guidance after Congress ordered it to rethink the policies discussed in that version, which industry complained woul...
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    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...