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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
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.
FDA approves first disposable duodenoscope
The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope.
FDA: Sterilization facility closures could prompt future device shortages
The Food and Drug Administration today alerted the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close.
FDA updates guidance on regulating digital health tools
The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk.