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FDA issues import alert, additional recommendations against using plastic syringes made in China
The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes.
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 advises against using plastic syringes made in China
U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced.
FDA approves combo test for flu, COVID-19; alerts providers to medical device risks
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19.
FDA adds vaporized hydrogen peroxide as an established medical device sterilization method
In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an established sterilization method for medical devices.
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.
AHA urges EPA to ensure ethylene oxide standards don’t disrupt supply chain
Commenting yesterday on the Environmental Protection Agency’s proposed standards for ethylene oxide use to sterilize medical devices, AHA encouraged the agency to give commercial sterilization facilities sufficient time to comply with any final standards to protect access to safe and sterile medical devices for patient care.
EPA sets 2024 date for ethylene oxide emissions rule; extends comment period to June 27
The Environmental Protection Agency May 30 announced its intent to finalize by March 1, 2024, new rules governing emissions from ethylene oxide, the gas widely used in medical sterilization facilities.
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.
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.