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  • Regulatory NewsRegulatory News

    FDA finalizes blood glucose monitor guidances

    The US Food and Drug Administration (FDA) on Monday finalized guidance providing recommendations for device makers looking to submit 510(k)s for prescription point-of-care and over-the-counter blood glucose monitoring systems (BGMSs), two years after the agency went back to the drawing board to address concerns about its previous guidance.   FDA first issued final guidance on point-of-care and over-the-counter BGMSs in October 2016. In November 2018, in response to ind...
  • Regulatory NewsRegulatory News

    Breast implant label guidance finalized by FDA

    The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries to track real-world data on breast implants.   FDA reco...
  • Regulatory NewsRegulatory News

    FDA finalizes ASCA pilot guidance as it gears up for launch

    The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.   The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible con...
  • Regulatory NewsRegulatory News

    FDA issues proposed rule clarifying stance on intended use

    After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.   The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a propos...
  • Regulatory NewsRegulatory News

    Convergence: Thinking beyond the registry for real-world device evidence

    Medical device registries can provide rich fields for data mining when real-world evidence is sought. But most medical devices will never land on a registry. Does this mean that these manufacturers will not be able to find a source of real-world data?   Not according to Heather Colvin, who spoke during a real world evidence-focused session at RAPS Convergence 2020. Colvin is the director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson. Sh...
  • Regulatory NewsRegulatory News

    Voluntary consensus standards guidance updated by FDA

    Voluntary consensus standards guidance updated by FDA   The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September 2018 version.   The final guidance also supersedes one issued in 2007 by the Center for Devices and Radiological Health (CDRH) entitled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition.”   The final document, ...
  • Regulatory NewsRegulatory News

    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...
  • Regulatory NewsRegulatory News

    MHRA posts suite of post-transition guidances

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • ReconRecon

    Recon: Drugmakers counter Trump's pricing plan; Teva indicted by US DOJ on price-fixing charges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers deliver counteroffer to Trump international pricing plan ( Politico ) Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide ( Pink Sheet ) Eric Topol Criticizes FDA's Exaggeration Of Plasma's Efficacy In COVID-19 Treatment ( NPR ) Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy ( KHN ) O...
  • Regulatory NewsRegulatory News

    European Commission sets common specifications for reprocessing single-use devices

    The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).   Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common sp...
  • Regulatory NewsRegulatory News

    FDA qualifies decision tool for breast reconstruction studies

    The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced. “An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement , which noted its ...