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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 updates sterilization standards for medical device makers
The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical device sterilization processes.
FDA releases transition plans for medical device enforcement, authorization after COVID-19 public health emergency
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations.
AHA opposes tariffs imposed on medical equipment, products
The AHA opposes tariffs that have been imposed on medical equipment and medical products imported from China that are used in hospitals, as well as potential tariffs under consideration that would impact the health care field.
FDA announces coming changes to premarket review of medical devices
The Food and Drug Administration intends to finalize guidance early next year on a new approach to its 510(k) program for pre-market review of medical devices.
FDA seeks input for future guidance on 3D printing at the point of care
The Food and Drug Administration released a discussion paper on 3D printing of medical devices at the point of care to facilitate input from stakeholders and others to inform future guidance. The agency will accept comments on the paper for 60 days.
Dynamic Ventilator Reserve
Websites
The Dynamic Ventilator Reserve is a public-private partnership between the American Hospital Association, the federal government and leading group purchasing organizations. This program brings together health systems from across the country to contribute a portion of their ventilator fleets to share with hospitals experiencing shortages.
AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical Devices
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
I&L Committee Topic: Ethylene Oxide (EtO) Sterilization
AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental,
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio