Medical Device Safety
FDA releases transition plans for medical device enforcement, authorization after COVID-19 public health emergency
Mar 24, 2023
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.
Nov 2, 2022
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.
Oct 14, 2022
Exela Pharma Sciences this week recalled 49 lots of sodium bicarbonate injection because the vial may break while preparing the product for administration, causing glass to fly.
Sep 7, 2022
Philips Respironics has recalled more than 17 million masks used with Bilevel Positive Airway Pressure and Continuous Positive Airway Pressure machines because the masks contain magnets that could cause serious injury to people with implanted metallic medical devices or other objects, the Food and…
Aug 11, 2022
The FDA announced a Class 1 recall of devices used to access blood vessels through a patient’s bone because the devices may malfunction, and recommended customers quarantine the devices.
Aug 3, 2022
The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.
Jul 25, 2022
Baxter Healthcare Corp. recently recalled its Abacus software for ordering compounded liquid medications due to a risk the printed bag labels may contain incorrect information, the FDA announced.
Jul 20, 2022
Smiths Medical recently recalled more than 118,000 Medfusion syringe infusion pumps whose software could malfunction, the FDA announced.
Jul 5, 2022
CVS Health and Walgreens recently launched clinical trials businesses with an eye toward reducing research costs and making it easier for historically underrepresented racial and ethnic groups to participate in drug and medical device studies.
Jun 9, 2022
The FDA released an update on Medtronic’s recall of 1,614 devices used to pump blood from the heart to the rest of the body