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  • Regulatory NewsRegulatory News

    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • Regulatory NewsRegulatory News

    FDA Addresses Questions on 510(k) Third-Party Review Program

    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act . The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize...
  • Regulatory NewsRegulatory News

    CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

    A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a patient-reported outcome (PRO). The research , led by statisticians Chul Ahn and Xin Fang at FDA’s Center for Devices and Radiological Health (CDRH), seeks to arrive at an acceptable level of probability for a PRO measure to reveal the “truth” of a subject’s disease or health condition. It comes at time when the science of ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
  • Regulatory NewsRegulatory News

    Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess

    Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week. McConnell called to renew the user fee programs as they are “critical to speeding up the drug approval process, and that’s important for everyone frustrated by the time and cost of bringing lifesaving drugs to market. Without it, ...
  • Regulatory NewsRegulatory News

    House Passes Bill to Reauthorize FDA User Fee Programs

    In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name dr...
  • Regulatory NewsRegulatory News

    House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess

    The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off. The bipartisan House user fee bill , which sailed through the Energy & Commerce committee unanimously last month, has be...
  • Feature ArticlesFeature Articles

    Navigating the Medical Device User Fee Act (MDUFA)

    This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...
  • Regulatory NewsRegulatory News

    HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees

    Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...
  • Regulatory NewsRegulatory News

    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...