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  • Regulatory NewsRegulatory News

    EC floats cross-sector health innovation partnership

    In a draft document issued 29 July, the European Commission (EC) unveiled its plan for integration of health technology capabilities across the European Union (EU). The plan was lauded by five pharmaceutical and medical technology associations who signed on to a joint statement welcoming the proposal.   Dubbed the Partnership for Health Innovation, the initiative aims to facilitate translational work by creating an EU-wide “health research and innovation ecosystem,” to...
  • Regulatory NewsRegulatory News

    FDA exempts additional Class II devices from 510(k) requirements

    The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory burdens on industry for makers of those devices.   Under the 21 st Century Cures Act , FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I device...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...
  • Regulatory NewsRegulatory News

    Updates on MDR implementation, transparency; MDCG posts CEAR template

    The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.   The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medic...
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    House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

    The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.   (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more , Regulatory Focus 29 January 2020).   “These bills will expand coverage and access to car...
  • Regulatory NewsRegulatory News

    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
  • FDA guidance addresses ultrasonic prostate ablation submissions

    A new final guidance from the US Food and Drug Administration (FDA) addresses clinical testing and clinical data collection to support marketing authorizations for high intensity ultrasound systems to ablate prostate tissue.   The agency clarified in the guidance that the scope is limited to clinical investigations that support authorization to market the devices for “general indications of prostate tissue ablation systems,” including those regulated under the PLP...
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    Electronic device submissions addressed in FDA guidance

    A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts of electronic submissions, as well as the timing of implemention, will be provided in upcoming guidances.   One guidance document is insufficient for describing and implementing electronic formats for all types of submissions covered under the statutory requirements, said F...
  • Regulatory NewsRegulatory News

    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
  • Regulatory NewsRegulatory News

    FDA proposes changes to atherectomy, BPH device guidances

    The US Food and Drug Administration (FDA) on Monday released two draft guidances proposing changes to two final device guidances, one on 510(k) submissions for peripheral vascular atherectomy devices and the other on clinical and nonclinical investigations for devices intended to treat benign prostatic hyperplasia (BPH).   Both draft guidances present updates to sections of the related final guidances that will be incorporated into the documents following a public cons...
  • Regulatory NewsRegulatory News

    French notified body GMED designated under MDR

    France’s GMED on Wednesday became the country’s first notified body designated under the Medical Devices Regulation (MDR) and the 15 th overall with less than a year before the regulation’s new date of application.   The Paris-based GMED is the sixth to be designated in 2020, following the designation of Swedish notified body Intertek in May. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory Focus 24 April 2020; Swedish notified bo...
  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...