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  • Regulatory NewsRegulatory News

    House Committee Considers Four Device Bills to Add to User Fee Reauthorization

    The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...
  • Regulatory NewsRegulatory News

    AdvaMed CEO Confident of Device Tax Repeal This Year

    The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year. Whitaker made the remarks during a call with reporters on Tuesday, where he also discussed potential changes to the US Food and Drug Administration's (FDA) inspection program for devices. Device Tax Repeal Despite the stalling of the Obamacare replacement b...
  • Regulatory NewsRegulatory News

    FDA Offers its Views on Medical Device Trials

    Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array of clinical trial designs and data sources that may be used to support the safety and effectiveness of medical devices. Unlike for pharmaceuticals, which generally see double-blind, randomized, Phase 3 trials assessing outcomes prior to approval, "practical limitations related ...
  • Regulatory NewsRegulatory News

    FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers

    The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations. Background In September 2013, FDA published a final rule creating a UDI system and outlining labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the US, unless a...
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    AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017

    Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies. In addition to recommending that FDA finalize all of the draft guidances issued within the last year, the list of seven final guidance documents (of the 12 listed in FDA’s "A" list for 2017, meaning the agency has a...
  • Regulatory NewsRegulatory News

    Obamacare Repeal Bill Would Eliminate Tax on Device Companies

    Late Monday, the GOP unveiled its Obamacare replacement bill with at least one provision that medical device companies will like: a permanent repeal of the 2.3% medical device tax. The tax’s full repeal, which was floated in standalone legislation in early January, would begin 1 January 2018 under the new version of Obamacare, known as the American Health Care Act (AHCA). That full repeal would also come more than two years after the tax was suspended following a ...
  • Feature ArticlesFeature Articles

    MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

    The following article represents the views and interpretations of the author and do not necessarily reflect those of RAPS: This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR. Introduction Both the MDR: the EU Medical Device Regulation, 2012/0266 (COD) and ...
  • Regulatory NewsRegulatory News

    Industry Group Links More Than 28,000 Job Losses to Device Tax

    As part of its push to fully repeal the medical device tax from the Affordable Care Act , industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect. Citing data from the Commerce Department, AdvaMed notes that from 2012 to 2015, the number of medical technology jobs in the US declined from 401,472 to 372,638, and though the group does not explicitly say the job loss...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...
  • Regulatory NewsRegulatory News

    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...
  • Regulatory NewsRegulatory News

    Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days ), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device. The draft comes as the controversy over Mylan’s EpiPen has simmered down, though the only current gener...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs). "A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can ensure appropriate patient and participant protections in investiga...