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  • 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 ...
  • 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...
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    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...
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    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 ...
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    FDA finalizes recommendations for enrolling males in breast cancer trials

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance making recommendations to sponsors encouraging them to enroll male patients in breast cancer clinical trials.   The final guidance comes one year after the agency issued the draft version for comment and includes only minor changes from the previous iteration. (RELATED: FDA calls for men to be enrolled in breast cancer trials , 26 August 2019) .   As in the draft version, FDA explains that ...
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    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...
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    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...
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    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
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    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...
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    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...