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    This Week at FDA: User fee update, Califf nomination, and more

    Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transmitted three of FDA’s user fee packages to Congress – with one notable exception – and, as we reported on Thursday, FDA is one step closer to having a permanent commissioner.   Earlier this week, we read that FDA and the medical device...
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    Senate committee advances Califf’s nomination as FDA commissioner

    The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).   The vote split largely along party lines, with six Republicans joining Sens. Bernie Sanders (I-VT) and Maggie Hassan (D-NH) in voting against moving the nomination forward. Both Sanders and Hassan , along with Sens. Joe Manchin (D-WV) and Ed Markey (D...
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    Woodcock defends COVID test review priorities to Congress

    Facing questions from members of the Senate Health, Education, Labor & Pensions Committee, Acting FDA Commissioner Janet Woodcock defended the agency’s move to prioritize the review of at-home and point-of-care tests based on manufacturing capacity.   The agency has so far granted emergency use authorizations (EUAs) to more than 400 COVID-19 tests and sample collection devices, including more than a dozen over-the-counter tests for at-home use.   “The agency’s been...
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    IVDR: European Commission publishes second batch of harmonized standards

    On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The standards cover topics including sterilization, aseptic processing, quality management systems, the use of symbols in product information, and requirements for establishing metrological traceability of certain values for calibrators,...
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    FDA seeks comment on device shortage reporting guidance

    The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing interruptions created under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   The CARES Act was signed into law in the early months of the COVID-19 pandemic and, for the first time, established requirements for medical device makers to notify FDA of permanent discontinuances...
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    This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents

    Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s nomination to lead the FDA. Plus, we get word that FDA’s move to harmonize its quality system regulation with ISO 13485:2016 may finally be on the horizon.   Last month, Califf breezed through his nomination hearing in front of the Senate Committee on Health, Education, Labor an...
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    European Commission publishes second batch of harmonized standards under MDR

    The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR).   The standards cover topics including the biological evaluation of medical devices, sterilization, aseptic processing, quality management systems, the use of symbols in product information, and more.   The nine newly recognized harmonized stand...
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    FDA temporarily halts inspections due to omicron

    As the US and other countries grapple with record-high COVID-19 cases driven by the omicron variant, the US Food and Drug Administration (FDA) has once again halted many of its domestic and foreign inspections.   Just before the New Year, on 29 December, FDA “implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread ...
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    Computational modeling and simulation: FDA outlines framework for assessing credibility

    With the use of computational modeling and simulation (CM&S) in medical device submissions on the rise, the US Food and Drug Administration (FDA) last month issued draft guidance detailing a risk-based framework for how to assess the credibility of such models.   Within the 36-page guidance, the agency lays out a nine-step generalized framework for assessing the credibility of computational modeling in a regulatory submission and provides additional details on the key ...
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    FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

    The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).   The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakehold...
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    IVDR’s progressive rollout gets official with EU Council, Parliament adoption

    The progressive rollout of the In Vitro Diagnostic Medical Devices Regulation (IVDR) is now official, after the European Parliament and Council adopted an amendment setting new dates of application for some of the regulation’s requirements.   Following significant pressure from industry and facing fears of a market collapse for diagnostics amid the COVID-19 pandemic, the European Commission announced it would delay certain provisions of the IVDR in October. The Commi...
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    Fall Unified Agenda: A look at FDA’s planned rulemaking

    The Biden administration’s second regulatory agenda for the US Food and Drug Administration (FDA) largely picks up where the previous agenda left off.   Released by the White House Office of Management and Budget last week, the Fall 2021 Agency Rule List contains 85 proposed and final rules the agency plans to issue under FDA’s purview. More than half of those rules pertain to human medical products or their development, with the remainder related to animal medical pro...