FDA News Briefs for Monday, January 7, 2019January 7, 2019
These Food and Drug Administration (FDA) developments came in last week:
Update on Recalled ARB Products
The FDA has posted updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan, and irbesartan. There are multiple recalls due to the presence of N-Nitrosodiethylamine (NDEA) and/or and N-Nitrosodimethylamine (NDMA) in affected products. NDMA and NDEA are probable human carcinogens and should not be present in drug products. The FDA has posted a list of recalled valartan products and a list of recalled irbesartan products, as well as a list of products that have not been recalled. More Information.
FDA Grants De Novo Clearance for Scanner that Detects Risk of Pressure Ulcers
The FDA has granted de novo classification for the SEM Scanner (Bruin Biometrics Inc.). The SEM Scanner is a pressure ulcer management tool, which is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention; it is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes. The SEM Scanner is a hand-held, portable, wound assessment device that measures changes in sub-epidermal moisture (SEM), a biophysical marker associated with localized edema in the inflammatory phase. More Information.