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24 Results Found
FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devic
GAO recommends FDA, CISA update medical device security documentation based on AHA input
The Government Accountability Office Dec. 21 recommended the Food and Drug Administration and Cybersecurity and Infrastructure and Security Agency update a 5-year-old agreement regarding medical device security.
Report offers ways to address cybersecurity challenges posed by legacy medical devices
The Food and Drug Administration on Nov. 16 announced a new report from government contractor MITRE, Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks.
FDA webinar Oct. 31 on proposed rule for laboratory developed tests
On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro diagnostic products.
FDA approves first sterilization system for 3D-printed medical devices
The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities.
EPA proposes new standards for ethylene oxide sterilizing facilities
The Environmental Protection Agency today proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide (EtO), a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative methods.
FDA releases FAQs on new requirements for medical devices vulnerable to cybersecurity threats
Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain cybersecurity requirements if they connect to the internet and contain software and technological characteristics vulnerable to cybersecurity threats.
FDA reports issues with certain reworked Philips ventilators
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic backing, potentially blocking the air inlet and lowering inspiratory pressure, FDA said.
FDA updates EUAs for COVID-19 antigen tests, alerts providers to device recall and shortage
The FDA revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing, and designated the recall of 60,500 filters used in breathing systems a Class I recall.
FDA issues update on heart device recall
All hospitals may request a backup controller with modified software for the Heartware Ventricular Assist Device System to use in certain circumstances if the primary controller fails to restart the pump, the Food and Drug Administration announced today.