CDRH https://www.bioworld.com/rss en-us FDA hints that QMSR is retroactive for applications, inspections http://www.bioworld.com/articles/725509 Tue, 04 Nov 2025 11:00:00 -0500 https://www.bioworld.com/articles/725509-fda-hints-that-qmsr-is-retroactive-for-applications-inspections FDA icons and doctor FDA’s AI life cycle guidance falls in importance for 2026 http://www.bioworld.com/articles/724498 Fri, 03 Oct 2025 12:00:00 -0400 https://www.bioworld.com/articles/724498-fdas-ai-life-cycle-guidance-falls-in-importance-for-2026 Hourglass on glowing circuit board, symbolizing time and technology Baxter clarifies Novum IQ update, but root cause unclear http://www.bioworld.com/articles/722530 Mon, 28 Jul 2025 12:00:00 -0400 https://www.bioworld.com/articles/722530-baxter-clarifies-novum-iq-update-but-root-cause-unclear FDA icons and doctor FDA rapidly lists raft of class I device recalls http://www.bioworld.com/articles/720667 Fri, 06 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/720667-fda-rapidly-lists-raft-of-class-i-device-recalls Product recall concept image FDA’s Tarver says agency open to improvement of third-party reviews http://www.bioworld.com/articles/719541 Thu, 01 May 2025 12:00:00 -0400 https://www.bioworld.com/articles/719541-fdas-tarver-says-agency-open-to-improvement-of-third-party-reviews U.S. FDA headquarters FDA says changes in Dexcom G6, G7 sensors constitute misbranding http://www.bioworld.com/articles/718261 Wed, 26 Mar 2025 12:00:00 -0400 https://www.bioworld.com/articles/718261-fda-says-changes-in-dexcom-g6-g7-sensors-constitute-misbranding Dexcom G7 CGM Dexcom Inc.’s G7 continuous glucose monitor. Smith’s Medical removes endotracheal tubes due to small diameter http://www.bioworld.com/articles/718207 Tue, 25 Mar 2025 11:00:00 -0400 https://www.bioworld.com/articles/718207-smiths-medical-removes-endotracheal-tubes-due-to-small-diameter Product recall concept image Shuren confirms Tarver in as FDA’s device center director http://www.bioworld.com/articles/713177 Fri, 18 Oct 2024 12:00:00 -0400 https://www.bioworld.com/articles/713177-shuren-confirms-tarver-in-as-fdas-device-center-director Michelle Tarver, FDA device center director Michelle Tarver, director of the FDA's Center for Devices and Radiological Health FDA divisions to develop pilot for companion diagnostic performance criteria http://www.bioworld.com/articles/691889 Wed, 23 Nov 2022 13:00:00 -0500 https://www.bioworld.com/articles/691889-fda-divisions-to-develop-pilot-for-companion-diagnostic-performance-criteria FDA divisions to develop pilot for companion diagnostic performance criteria http://www.bioworld.com/articles/691817 Tue, 22 Nov 2022 13:00:00 -0500 https://www.bioworld.com/articles/691817-fda-divisions-to-develop-pilot-for-companion-diagnostic-performance-criteria FDA adds orthopedic fracture fixation plates to device types eligible for 510(k) alternative http://www.bioworld.com/articles/517961 Thu, 14 Apr 2022 13:00:00 -0400 https://www.bioworld.com/articles/517961-fda-adds-orthopedic-fracture-fixation-plates-to-device-types-eligible-for-510k-alternative Third-party reviews of 510(k) applications trending nearly flat since 2018 http://www.bioworld.com/articles/517864 Tue, 12 Apr 2022 13:00:00 -0400 https://www.bioworld.com/articles/517864-third-party-reviews-of-510k-applications-trending-nearly-flat-since-2018 FDA reviewers seen resurrecting trend of increasing demands for data BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.]]> http://www.bioworld.com/articles/516538 Tue, 01 Mar 2022 13:00:00 -0500 https://www.bioworld.com/articles/516538-fda-reviewers-seen-resurrecting-trend-of-increasing-demands-for-data U.S. FDA headquarters Stakeholders prod FDA to include drugs in scope of device software functions guidance http://www.bioworld.com/articles/515963 Thu, 10 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/515963-stakeholders-prod-fda-to-include-drugs-in-scope-of-device-software-functions-guidance Laptop displaying FDA logo FDA’s strategic priorities include bringing half of new technologies to US market first or in parallel http://www.bioworld.com/articles/515761 Thu, 03 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/515761-fdas-strategic-priorities-include-bringing-half-of-new-technologies-to-us-market-first-or-in-parallel U.S. FDA headquarters CDRH releases Health of Women Program Strategic Plan for medical devices http://www.bioworld.com/articles/515233 Tue, 18 Jan 2022 13:00:00 -0500 https://www.bioworld.com/articles/515233-cdrh-releases-health-of-women-program-strategic-plan-for-medical-devices U.S. FDA headquarters AI change control draft a second-tier entry in FDA guidance agenda for 2022 http://www.bioworld.com/articles/512773 Tue, 26 Oct 2021 13:00:00 -0400 https://www.bioworld.com/articles/512773-ai-change-control-draft-a-second-tier-entry-in-fda-guidance-agenda-for-2022 FDA icons FDA’s Shuren stays on message regarding resources as user fee discussions continue http://www.bioworld.com/articles/508532 Tue, 22 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508532-fdas-shuren-stays-on-message-regarding-resources-as-user-fee-discussions-continue U.S. FDA headquarters FDA clarifies distinction between remanufacturing and servicing of medical devices http://www.bioworld.com/articles/508371 Thu, 17 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508371-fda-clarifies-distinction-between-remanufacturing-and-servicing-of-medical-devices FDA icons Trust, interoperability are key issues in generation, use of patient-generated health data http://www.bioworld.com/articles/508368 Thu, 17 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508368-trust-interoperability-are-key-issues-in-generation-use-of-patient-generated-health-data Scientific data illustration FDA responds to NIST call on cybersecurity executive order http://www.bioworld.com/articles/508037 Wed, 09 Jun 2021 13:00:00 -0400 https://www.bioworld.com/articles/508037-fda-responds-to-nist-call-on-cybersecurity-executive-order Lock on digital globe illustration Shuren floats optional total product life cycle advisory mechanism http://www.bioworld.com/articles/507285 Wed, 19 May 2021 13:00:00 -0400 https://www.bioworld.com/articles/507285-shuren-floats-optional-total-product-life-cycle-advisory-mechanism Jeff Shuren Jeff Shuren, former director of the FDA's Center for Devices and Radiological Health CDRH guidance agenda another victim of COVID-19 pandemic http://www.bioworld.com/articles/505890 Tue, 13 Apr 2021 13:00:00 -0400 https://www.bioworld.com/articles/505890-cdrh-guidance-agenda-another-victim-of-covid-19-pandemic U.S. FDA headquarters Advamed says FDA should clarify when patient-reported outcome instruments need revalidation http://www.bioworld.com/articles/499725 Tue, 03 Nov 2020 12:00:00 -0500 https://www.bioworld.com/articles/499725-advamed-says-fda-should-clarify-when-patient-reported-outcome-instruments-need-revalidation Advamed says FDA should clarify when patient-reported outcome instruments need revalidation http://www.bioworld.com/articles/499674 Mon, 02 Nov 2020 12:00:00 -0500 https://www.bioworld.com/articles/499674-advamed-says-fda-should-clarify-when-patient-reported-outcome-instruments-need-revalidation FDA’s Shuren pounds on inadequacy of statute in CDRH town hall http://www.bioworld.com/articles/498643 Tue, 06 Oct 2020 13:00:00 -0400 https://www.bioworld.com/articles/498643-fdas-shuren-pounds-on-inadequacy-of-statute-in-cdrh-town-hall Jeff Shuren Jeff Shuren, former director of the FDA's Center for Devices and Radiological Health Trautman: COVID-19 may hamper FDA’s efforts to further harmonize Part 820, ISO 13485 BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.]]> http://www.bioworld.com/articles/455844 Fri, 17 Jul 2020 13:00:00 -0400 https://www.bioworld.com/articles/455844-trautman-covid-19-may-hamper-fdas-efforts-to-further-harmonize-part-820-iso-13485 Digital illustration of U.S., coronavirus Legislators press White House to activate DPA to combat COVID-19 http://www.bioworld.com/articles/433924 Tue, 24 Mar 2020 12:00:00 -0400 https://www.bioworld.com/articles/433924-legislators-press-white-house-to-activate-dpa-to-combat-covid-19 Coronavirus vs U.S. wrecking balls Device warnings resurgent despite FDA’s claim Theranos discovery a distraction http://www.bioworld.com/articles/432899 Thu, 06 Feb 2020 12:00:00 -0500 https://www.bioworld.com/articles/432899-device-warnings-resurgent-despite-fdas-claim-theranos-discovery-a-distraction Medtronic scores breakthrough device designation for TAAA stent graft system http://www.bioworld.com/articles/430113 Wed, 09 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430113-medtronic-scores-breakthrough-device-designation-for-taaa-stent-graft-system