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  • Regulatory NewsRegulatory News

    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
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    FDA Lays Out New Areas of Interest for Training Device Review Staff

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia, and health care facilities to participate again in a program that helps train medical device review staff. The 2015 Experiential Learning Program (ELP) General Training Program, which was first launched in September 2011, is intended to provide CDRH staff with a better understanding of the policies, laboratory practices and challenges of t...
  • Regulatory NewsRegulatory News

    FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization

    As the US Food and Drug Administration (FDA) and industry look to deliver recommendations to Congress on the reauthorization of the Medical Device User Fee Amendments (MDUFA) by January 2017, both sides agreed to limit their focus to three top priorities for future stakeholder meetings. The topics nominated in late October as the top priorities include how to incorporate patient perspectives into FDA reviews, how postmarket and premarket device evidence will be better ut...
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    FDA Sees Record-High PMA Approval Rate for 2015

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...
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    CDRH Increases Foreign Quality System Inspections

    Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH). CDRH said the new numbers show that the agency, which previously upped its inspections of foreign generic drug manufacturers , has been working to increase inspections in foreign count...
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    CDRH Unveils Top Regulatory Science Priorities for 2016

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
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    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
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    FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices. The committee, which will be made up of nine voting members, one non-voting industry representative and one non-voting consumer representative, will bring together patients, patient a...
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    FDA's CDRH Adds New Online Tools to Help Industry Learn the Ropes

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released seven new modules of online information this week designed to help industry understand the various parts of medical device laws, regulations and policies. The multimedia catalog of online educational modules, known as CDRH Learn, has now grown to over 80 educational modules, which include presentations, printable slides and transcripts. FDA began releasing...
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    IMDRF Participants Outline Plans for Next Week’s Meeting in Japan

    In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share. Background Begun in 2011, IMDRF is a voluntary group of medical device regulators from Australia, Brazil, Canada, China, EU, Japan and the US, as well as the World Health Organization (WHO), with the aim of accelerating international medical...
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    FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

    The US Food and Drug Administration has just released a list of all medical device guidance documents it plans to release in 2015, including ones related to speeding up device submissions, regulating lab-developed tests (LDTs) and the regulation of decision support software. Background The list, sometimes referred to as a "Guidance Agenda," is published on an annual basis by FDA's Center for Devices and Radiological Health, its medical device regulatory division. The ...
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    As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

    Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups , including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress. Background LDTs are, as their name imp...