FDA, device manufacturers make deal on user fees
Editor's Note The Food and Drug Administration and medical device manufacturers have made a deal on user fees companies pay to have the FDA review their products, the August 23 Mass Device reports. The Medical Device User Fee & Modernization Act IV will allow the FDA to collect nearly $1…
FDA expands indication for two transcatheter aortic valves
Editor's Note The Food and Drug Administration (FDA) on August 18 approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic stenosis. The new indication is for patients who are at intermediate risk for death or complications associated with open-heart surgery. Previously,…
FDA: Sagent Pharmaceuticals recalls one lot of Oxacillin for Injection
Editor's Note The Food and Drug Administration (FDA) on August 19 announced the recall by Sagent Pharmaceuticals, Inc (Schaumburg, Illinois), of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp Date March 2017). The recall was initiated because of a user complaint of a vial…
FDA issues safety alert on Custom Ultrasonics reprocessors
Editor's Note The Food and Drug Administration (FDA) on August 17 issued a Safety Alert on the System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics (Warminster, Pennsylvania), recommending that healthcare facilities stop using them to reprocess duodenoscopes. The system may still be used for reprocessing endoscopes other than duodenoscopes.…
FDA: Cook Medical recalls Roadrunner UniGlide Hydrophilic Wire Guides
Editor's Note The Food and Drug Administration (FDA) on August 15 announced the recall by Cook Medical (Bloomington, Indiana) of 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because of concerns about a potential contamination of the wires’ hydrophilic coating with glass particles. The wire guides are used in…
FDA issues draft guidance on when to seek reapproval for medical devices
Editor's Note The Food and Drug Administration (FDA) on August 8 published draft guidance on when medical device manufacturers and software developers must obtain FDA clearance before making changes to existing products, the August 8 Modern Healthcare reports. The draft says if the “overall structure” of a device’s software is…
FDA: Hospira recalls one lot of 0.25% Bupivacaine Hydrochloride Injection
Editor's Note The Food and Drug Administration (FDA) on August 5 reported that Hospira, Inc (Lake Forest, Illinois) is recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064-DK, Expiry 1 Nov 2017) because of the presence of particulate matter found in a single vial. The lot…
Medical device companies scrambling to meet UDI deadline
Editor's Note A survey by Loftware, Inc (Portsmouth, New Hampshire), shows that only 15% of medical device companies are currently compliant with the next phase of the Food and Drug Administration's Unique Device Identification (UDI) regulation, the August 3 PRWEB reports. The deadline is September 24. Of 120 companies polled,…
FDA advises Florida blood banks to cease blood collection
Editor's Note The Food and Drug Administration (FDA) on July 27 requested that all blood establishments in Miami-Dade and Broward Counties cease collecting blood immediately until they implement testing of each unit of blood with an investigational donor screening test for Zika virus RNA or the use of an approved…
FDA issues draft UDI guidance
Editor's Note The Food and Drug Administration (FDA) on July 26 issued a draft Unique Device Identification (UDI) guideline that requires most medical device labels and packages to bear a UDI in easily readable plain-text and automatic identification and data capture technology forms. UDIs must be issued under a system…
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