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  • Regulatory NewsRegulatory News

    Medtech groups want more time to implement FDA’s QMSR rule

    Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.   In February, FDA published a long-awaited proposed Quality Management System Regulation (QMSR) rule to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with the international stan...
  • Regulatory NewsRegulatory News

    FDA takes steps to relax blood donor requirements

    The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive blood while not significantly increasing risk to donors and patients.   On 23 May, the Center for Biologics Evaluation and Research published two draft guidances titled Compliance Policy Regarding Blood and Blood Component Do...
  • Regulatory NewsRegulatory News

    Califf uses budget hearing to advocate for resources, authority to monitor supply chains

    A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula shortage in the country. In turn, Califf used the opportunity to ask lawmakers for more resources and authority to oversee the supply chains for products the FDA regulates.   Califf testified virtually on 19 May before the House Appropria...
  • Regulatory NewsRegulatory News

    User fee reauthorization bill advances in the House, Senate eyes different riders

    The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one proposed in the Senate because of severe time constraints, according to an industry source with extensive legislative Hill experience.   On 18 May, the Energy and Commerce committee voted to move forward with the much-anticipated Foo...
  • Regulatory NewsRegulatory News

    New report urges more clinical trial diversity, recommends incentives

    A new report commissioned by Congress makes significant recommendations for improving clinical trial diversity, including offering financial incentives that have typically been off the table for ethical reasons. The 403-page report addresses a range of stakeholders but specifically urges the US Food and Drug Administration (FDA) to hold sponsors accountable for enrolling more diverse participants in trials.   On 17 May, the National Academies of Sciences, Engineering a...
  • Regulatory NewsRegulatory News

    Euro Convergence: Attendees want end to regulatory ‘micromanagement’

    Corrected 13 May 2022* AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authorities: Trust us.   Gathered at RAPS Euro Convergence at a panel on how to better communicate with health authorities and notified bodies, they voiced their displeasure and asked for a respite from what they describe as micromanagement.   “You heard from academia, you heard from the early start-ups, you heard from the large manufacturers [at this confe...
  • Regulatory NewsRegulatory News

    Euro Convergence: AI, notified body shortage top health authorities session

    AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a townhall meeting at the 2022 RAPS Euro Convergence.   On 11 May, a high-level group of representatives from health authorities, notified bodies, and regulatory agencies opened themselves up for questions from delegates who asked them a...
  • Regulatory NewsRegulatory News

    Euro Convergence: Big data offers the potential to improve patient outcomes

    AMSTERDAM – Regulatory experts speaking at the opening plenary of RAPS 2022 Euro Convergence on 10 May discussed the potential to improve patient outcomes by harnessing the power of registries and other large databases, including Eudamed and the recently proposed European Health Data Space (EHDS).   Data, sharing and outcomes   Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University...
  • Regulatory NewsRegulatory News

    Outgoing CDRH digital health chief: Pre-Cert needs new legislative authorities

    Bakul Patel, the US Food and Drug Administration’s (FDA) former digital health chief, said he’s always known the agency needed additional congressional authorities to fully implement a new digital health products pathway in an interview with Focus on Sunday.   On 30 April, Patel, longtime digital health director for FDA’s Center for Devices and Radiological Health (CDRH), announced on LinkedIn that he was leaving the agency after more than 13 years.   “It truly...
  • This Week at FDAThis Week at FDA

    This Week at FDA: What we learned at MedCon, looking to RAPS Euro Convergence and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week we’ve been covering the annual MedCon 2022 conference, presented by the AFDO/RAPS Healthcare Collaborative. At the meeting, Jeff Shuren, FDA’s device center chief, said the agency is planning to ease back into holding pre-submission meetings for all products after hitting t...
  • Regulatory NewsRegulatory News

    IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback

    Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from the International Medical Device Regulators Forum (IMDRF). The draft is the result of feedback from a 2020 guidance that stakeholders said did not sufficiently address legacy products.   The draft guidance, published 4 May, outlines what is considered a legacy device, and how stakeholders ca...
  • Regulatory NewsRegulatory News

    First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing

    The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.   On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages...