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  • Regulatory NewsRegulatory News

    Industry Argues Against FDA Home-Use Device Label Database

    The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels. In October, FDA announced the proposed rule , which would require the makers of Class II and Class III medical devices intended for home-use to submit the labels and package inserts for their products electronically. These electronic labels and package insert...
  • Regulatory NewsRegulatory News

    AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices

    Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions. The draft guidance, released in July and known as “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” is meant to bring FDA’s be...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • Regulatory NewsRegulatory News

    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...
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    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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    MDUFA IV Negotiations: FDA, Industry Propose New Performance Goals

    At the November meeting on the fourth iteration of the Medical Device User Fee Act (MDUFA IV), the US Food and Drug Administration (FDA) and industry representatives both unveiled new performance targets for de novo submissions, pre-submissions and third-party 510(k) reviews. The MDUFA IV proposal package, which would take effect in 2017, includes the goals of maintaining the MDUFA III FDA performance targets for 510(k) and premarket approval (PMA) submissions, though ...
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    Industry Weighs Integration of UDIs Into Medical Device Registry Network

    The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices. Background In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance , which detailed the agency's vision for improving device surveillance. One of the report's...
  • 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...
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    FDA Commissioner Outlines Critical Time Ahead for Agency

    As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years. FDA Acting Commissioner Stephen Ostroff told attendees on Tuesday at RAPS' Regulatory Convergence that he's seeing an "unusual confluence" of events, particularly as the House-passed  21st Century Cures leg...
  • Regulatory NewsRegulatory News

    Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

    The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices. Background The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed pat...
  • AdvaMed Outlines Wishlist for New Changes to 510(k) Process

    The system by which most medical devices reach the market, known as the premarket notification or 510(k) process, has been subject to a considerable amount of criticism in recent years, with detractors claiming that it is both too rigorous and not rigorous enough, and legislators ordering the US Food and Drug Administration (FDA) to scrap planned changes to the process in favor of one yet to be built. Now the influential trade industry group AdvaMed, the largest medical...
  • Medical Device Industry Comes Together to Slam Proposed Regulation on Clinical Trials

    The medical device industry is none too pleased with a proposed regulation released in February 2013 that would require all companies to make sure their clinical trials, no matter where in the world those trials are conducted, to adhere to US clinical trials regulations. Background The US Food and Drug Administration's (FDA) draft regulation, Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices , would notably require sponsors to o...