Devices
FDA has approved an emergency use authorization for a Roche Covid-19 at-home rapid test that can be used by people as young as 14. The company says the test uses an anterior nasal swab and produces “accurate, reliable, and quick results in as few as 20 minutes” for
Devices
FDA has issued an emergency use authorization for the Siemens Healthineers Clinitest Rapid Covid-19 Antigen Self-Test. The company says the test is for use by those age 14 and older or with adult-collected samples from individuals ages 2-13. Results will be available in 15 minutes. The
Devices
FDA has issued two draft medical device plans for the transition to normal operations from the policies adopted and operations implemented during the Covid-19 public health emergency. “FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies
Devices
FDA has authorized marketing of the Philips CavaClear Laser Sheath, the first laser-based device for removing inferior vena cava (IVC) filters. An agency statement says the device is intended for removing tissue to facilitate detachment of an IVC filter during retrieval when previous methods of removal have failed. The
Devices
FDA says Baxter Healthcare’s 4/26 recall of 268 units of its Volara system with an in-line ventilator adaptor is Class 1. An agency notice says the devices were distributed between 5/28/20 and 4/19/22. The system is intended to help people clear mucus out
Drugs
New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater
Devices
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices. The existing pilot program, which is limited to PMA devices, is intended to streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities. It was established to encourage
Devices
FDA is alerting clinical laboratory staff and health care providers that false reactivity or false positive Rapid Plasma Reagin (RPR) test results are possible when using Bio-Rad Laboratories’ BioPlex 2200 Syphilis Total & RPR kit. A false positive can occur in some people who received a Covid-19 vaccine,
Devices
Sens. Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Medical Device Integrity Act to give FDA the authority to request records and require that medical device manufacturers comply with the requests. In a statement, the senators say the measure will better prepare the U.S. for
Drugs
FDA has denied a 7/19 petition submitted by Buchanan Ingersoll Rooney asking that the agency: * review the basis for submission of an ANDA by Eugia Pharma Specialties; * determine that the ANDA should have been filed as a 505(b)(2) NDA; * conclude that FDA should have issued a refuse-
Devices
CDRH is planning to release “very soon” a long-awaited proposed rule to modernize the medical device Quality System Regulation (QSR) by harmonizing and “supplanting” existing requirements with the specifications in the International Organization for Standardization’s (ISO) 13485:2016. Speaking at a virtual Food and Drug Law Institute (FDLI)
Devices
FDA says the 10/27 Getinge/Datascope/Maquet recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is Class 1. An agency notice says the company recalled 4,338 devices in the U.S. manufactured between 12/2011 and the present and distributed 3/6/2012 to 10/
Drugs
An FDA 12/7/20-1/20/21 inspection at Dental Technologies, Lincolnwood, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and Quality System (QS) regulations for medical devices. An 11/30 Warning Letter identifies the specific violations as: * failing to thoroughly investigate any
Devices
FDA has published a draft guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Comment, Communications, and Other Public Documents, to promote clarity regarding references to the terms “device” and “counterfeit device.” The document says that as a result of the enactment
Devices
A 7/28-8/25 FDA inspection at the DeVilbiss Healthcare medical device operation in Somerset, PA, found Quality System regulation violations in the firm’s manufacturing of oxygen concentrators, nebulizers, suction units, non-continuous ventilators, and related accessories. An 11/23 Warning Letter says specific violations were: * failing to
Devices
FDA has approved Svelte Medical Systems’ Slender IDS fixed-wire and Direct RX rapid-exchange drug-eluting stent systems to treat coronary artery disease. The company says the two systems, incorporating the same stent, bioresorbable drug coating, and balloon technologies, achieved 1.5% clinically-driven target lesion revascularization at one
Devices
FDA has approved an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures. Optilume is designed as an alternative to traditional endoscopic stricture treatments. It dialates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence, according to
Devices
FDA’s Medical Devices Advisory Committee’s Neurological Devices Panel has voted 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate the device’s benefits outweigh its risks. The company is seeking an indication for increasing cerebral blood flow and to reduce disability in
Devices
CDRH has issued a discussion paper, “3D Printing Medical Devices at the Point of Care,” that proposes potential point-of-care (PoC) manufacturing scenarios for public comment. The paper identifies challenges presented by 3D-printed devices at PoC and offers a potential approach for regulatory oversight under various scenarios to
Devices
Medtronic’s Covidien unit has recalled its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Customers have been told to immediately discontinue use of the affected ventilators
Devices
FDA has approved a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Janssen’s Rybrevant (amivantamab-vmjw). The device uses
Devices
Entellus Medical and Jeffrey Gallups, founder, owner, medical director, and past-CEO of Milton Hall Surgical Associates (MHSA), that employed multiple physicians throughout north Georgia, have agreed to pay about $1.2 million and $3 million respectively to resolve allegations they violated the False Claims Act through an unlawful kickback