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  • 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, ...
  • ReconRecon

    Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Genentech scores sixth FDA approval in lung cancer with Gavreto ( Pharmafile ) US FDA Personnel Costs Drop: Is the Next Generation Taking Over? ( Pink Sheet ) Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA ( Pink Sheet ) Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma ( Forbes ) Here’s how Trump could bigfoot the FDA an...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA releases draft guidance on PROs for device manufacturers

    Device manufacturers have new draft guidance from the US Food and Drug Administration (FDA) for the selection of patient-reported outcome instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing instruments, and the possibility of nesting patient-reported outcome instruments within real-world data sources.   The new draft was jointly issued by the Center for Devices and Radiological Health and the ...
  • 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 lists medical devices in shortage under CARES authority

    For the first time, the US Food and Drug Administration (FDA) on Friday listed medical devices in shortage or that have been discontinued during the coronavirus disease (COVID-19) public health emergency using a new authority under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   The CARES Act amended the Federal Food, Drug, and Cosmetic Act by adding Section 506J, which requires manufacturers of certain devices to notify the agency of manufa...
  • Regulatory NewsRegulatory News

    FDA proposes down-classifying bone grown stimulators

    The US Food and Drug Administration (FDA) on Friday proposed to reclassify non-invasive bone growth stimulators under two product codes from class III to class II, allowing the devices to be marketed with 510(k) clearance rather than requiring premarket approval (PMA).   Non-invasive bone growth stimulators are postamendments devices that were automatically classified as class III devices in 1979 with the PMA for the Bio Osteogen System 204. FDA has since approved five...
  • Regulatory NewsRegulatory News

    FDA finalizes first device-specific safety and performance based pathway guidances

    More than two years after the US Food and Drug Administration (FDA) first proposed an alternate safety and performance based pathway for certain well-understood medical devices, the agency on Thursday finalized the first two device-specific guidances establishing performance criteria to support 510(k) clearance via the new pathway.   The two final guidances provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters ...
  • Regulatory NewsRegulatory News

    Device importers' COVID questions answered by FDA

    The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic.   The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.   In the question-and-answer format, FDA collates information and guidance documents pertinent to o...
  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...